AN OVERVIEW OF RANDOMIZED CONTROL TRIALS IN

ORTHODONTICS
Authors :

Varadharaja Muthukrishnan
Post graduate student

Sivakumar Arunachalam
Reader

Ashima Valiathan
Professor and Head of the Department
Address for correspondence:
Dr. Ashima Valiathan, B.D.S ( Pb), D.D.S, M.S (USA)
Director of Postgraduate Studies,
Professor and Head,
Department of Orthodontics and Dentofacial Orthopaedics,
Manipal College of Dental Sciences,
Manipal - 576104
Karnataka.
E-mail: avalaliathan@yahoo.com
Abstract

The comparison of technologies or alternative ways to accomplish the same aim, is inherently
difficult. In orthodontics, technology covers a wide spectrum of areas: variations in treatment
approach, appliances, wires, diagnostic procedures, and patient management techniques. Clinical trial methodology has been developed to minimize the effect of bias and to provide more
objective answers to questions of comparative efficacy and benefits of particular treatments or
procedures. The randomized controlled clinical trial (RCT) is now generally considered the strongest research design for the comparison of treatments. This article is intended to provide an
overview of the RCT's done in the field of orthodontics. They have been broadly classified and
discussed under 4 headings- RCT's in treatment techniques, biology and disorders, materials and
devices and retaining devices.

constructs or empirical evidence. Many of these

technologies have later been deemed ineffective. The
comparison of technologies, or alternative ways to
accomplish the same aim, is inherently difficult. Until
recently, comparisons in orthodontics have generally
depended on case series or observational studies.

Introduction
Clinical trials are always prospective studies, and can
be classified as (1) uncontrolled, if there is no
concurrent comparison group although historical
controls may be used; (2) nonrandom controlled trial,
if a concurrent comparison group is used but patients
allocation to each group occurs by means of some
nonrandom process (e.g., convenience or clinical
judgment); and (3) randomized controlled trial (RCT),
if subjects are randomly allocated into treatment and
control groups.

The Randomized clinical trial (RCT) is now generally

considered the strongest research design for the
comparison of treatment alternatives. The advantage
of the RCT is that it is prospective with subjects and
the data under some control by the investigator. The
treatment or intervention is randomly allocated, so
perceptions of the investigator on the value of a
particular treatment should not influence treatment
allocation, which could bias the results. The study is
planned before the data is collected; hence it results in

Technology in orthodontics covers a wide spectrum of

areas: variations in treatment approach, appliances,
wires, diagnostic procedures, and patient management
techniques. New developments or modifications of
existing methods are frequently based on theoretical
42

a minimization of bias that is inherent in the

retrospective study.

mandibular size alteration, and the treatment effects

were mostly vertical dimension increase.

First step in conducting a RCT is to define a sample

group from a group of population using inclusion and
exclusion criteria. Adequate sample size is calculated.
The treatment outcomes are clearly stated. Then the
sample is allotted to control and experimental group,
using selected randomization technique.
Randomization is central to the mechanics of the trial,
because by allocating participants randomly, patient
characteristics are likely to be similar across the groups
at the start. By keeping the groups balanced at baseline,
the outcomes can be attributed to the intervention with
minimal effects from other factors that may influence
the treatments. Three frequently used methods of
randomization are (1) Simple randomization is
equivalent to coin tossing. (2) Block randomization
assures that the number of subjects is closely balanced
at periodic intervals (3) Blocked stratification guards
against imbalances between the groups resulting in the
prognostic factor(s) being more evenly distributed
within the treatment groups

During the early 1990s, three American orthodontic

departments received around seven million dollars from
the National Institute of Dental Research (NIDR) to run
RCTs to study the effects of functional appliances and
headgear on Class II malocclusions. These schools were
the University of Pennsylvania, the University Florida,
and the University North Carolina. Inclusion criteria
of the RCT done in University of North Carolina were
overjet greater than 7mm and 1 year pre- peak height
velocity as judged by hand wrist radiograph. The
subjects were randomly assigned to observation only,
headgear, or functional appliance (modified bionator)
and were monitored for 15 months. It was shown that
headgear produces greater change in the maxilla
(restricted forward movement of the maxilla), whereas
functional appliance therapy produces greater
mandibular change (increase in mandibular length),
but there was considerable variation in the effect with
both appliance systems.3 Children in all three groups
were pooled together and continued into second phase
of treatment, where all underwent comprehensive fixed
appliance therapy. Results at end of second phase
showed that, time in fixed appliances was shorter for
children who underwent early treatment. Also, only
small differences were noted in anteroposterior jaw
position between the groups at the completion of
treatment. The number of patients who required
extraction of permanent teeth was greater in the early
functional appliance group than in the headgear or
control group. The option of orthognathic surgery was
presented more often in the cases of children who did
not undergo early treatment, but surgery was
considered almost as frequently in the previous
headgear group as in the controls, and less often in the
patients previously treated with functional appliances.4
Brin et al5 using the same sample showed that early
growth modification reduces the severity of overjet in
Class II malocclusion and might have a role in reducing
the likelihood of external apical root resorption.

The modern era of RCTs began in the early 1950s with

the evaluation of streptomycin in patients with
tuberculosis.
This article is intended to provide an overview of the
RCTs done in the field of orthodontics. Some articles
failed to state in the title or abstract that the paper was
reporting a clinical trial or those treatments were
allocated randomly. So, those articles that were
classified as RCT by Cochrane data bases and review
articles were included in this overview. For
convenience, RCTs in orthodontics are broadly
classified into 4 major topics,
1.
2.
3.
4.

RCTs in treatment techniques

RCTs in Biology and Disorders
RCTs in Materials and Devices
RCTs in retaining devices

In a similarly designed RCT at University of Florida,

children with Class II molars including subdivisions
were randomly assigned to control, bionator, and
headgear/biteplane treatments. Phase 1 results showed
that both bionator and headgear treatments corrected
Class II molar relationships. 6 The skeletal changes,
largely attributable to enhanced mandibular growth in
both headgear and bionator subjects, were stable a year
after the end of treatment, but dental movements
relapsed. They also suggested that headgear may be
superior to bionator/biteplane in achieving a Class II
correction during early treatment.7 Results at the end

RCTs in treatment techniques (Dentofacial

orthopedics, Temporary anchorage devices,
Expansion, Self Ligation etc)
RCTs in Treatment of Class II malocclusion
RCTs on the treatment of Class II treatment were first
conducted by Nelson1 and Webster2 at the University
of Otago. Their inclusion criteria were Class II division
1 with bilateral Class II malocclusion. Treatment with
Frankel, Harvold activator was compared with
untreated controls. They found no evidence on
43

of phase 2 comprehensive treatment showed that there

were no significant differences with respect to initial
PAR or final PAR among the 3 treatment protocols. They
did not support the hypothesis that different
dentoalveolar outcomes are obtained between 2-phase
and 1-phase treatment of Class II malocclusions.8 In
RCT done at University of Pennsylvania, children with
bilateral distoclusion (unilateral Class I excluded) and
a minimum ANB angle of 4.5 were assigned at random
to treatment with either a headgear or a Frankel group.
Ghafari et al9 showed that on average, the headgear
has a distal effect on the maxilla and first molars; The
Frankel FUNCTIONAL regulator restrains the growth
of the maxilla and results in a retroclination of the
maxillary incisors and a proclination of the mandibular
incisors. The effects of both appliances on mandibular
length were similar. A significant finding of the study is
the increased maxillary intercanine distance and
spacing among the maxillary anterior teeth with
headgear treatment. Treatment in late childhood was
as effective as that in mid childhood.

were randomly assigned to 1 of 3 groups: facemask

with palatal expansion, facemask without palatal
expansion, and observation for 12 months. Vaughn et
al13 found no significant differences between expansion
and non expansion groups in any measured variable.
This study demonstrated that facemask therapy with
or without palatal expansion produced equivalent
changes in the dentofacial complex that combined to
improve the Class III malocclusion.
RCTs in Distalization of molars
Bondemark and Karlsson14 using RCT methodology
compared intraoral and extraoral appliances for
distalization of maxillary molars and showed that
intraoral appliance was more effective than the
extraoral. Also, moderate anchorage loss was produced
with intraoral appliance implying increased overjet
whereas the extraoral appliance decreased overjet.
RCTs in Temporary Anchorage Devices
Sandler 15 and Benson 16 using RCT methodology
compared Midpalatal implants with Headgears for
distalization of molars and demonstrated that all skeletal
and dental points moved mesially more in the headgear
group during treatment than in the implant group. The
total number of visits was greater in the implant group,
but the overall treatment times were almost identical.
They concluded that Midpalatal implants are an
acceptable technique for reinforcing anchorage in
orthodontic patients.

In a Multicenter RCT in United Kingdom, subjects with

minimum of 7 mm overjet were randomly allocated to
receive treatment with a Twin-block appliance or to an
untreated, control group. After 15 months of observation,
OBrien10 showed that early treatment with the Twinblock appliance is effective in reducing overjet and
severity of malocclusion but most of this correction was
due to dentoalveolar change, but some was due to
favorable skeletal change. Twin-block appliances
resulted in an increase in self-concept and a reduction
of negative social experiences. The subjects also reported
treatment benefits that could be related to improved selfesteem.11 The second phase results are yet to be
published; provisional results indicate that, at the end
of phase 2 treatment, there were no differences between
the patients who had early treatment and those who did
not. In another multicentre RCT, Subjects with minimum
of 7 mm overjet were randomly allocated to receive
treatment with a Herbst or Twin-block appliance. Results
showed that treatment with the Herbst appliance resulted
in a lower failure-to-complete rate. OBrien12 found that
there were no differences in treatment time between
appliances, but significantly more appointments were
needed for repair of the Herbst appliance than for the
Twin-block. There were no differences in skeletal and
dental changes between the appliances. Because of the
high cooperation rates of patients using it, the Herbst
appliance could be the appliance of choice for treating
adolescents with Class II Division 1 malocclusion.

Feldmann and Bondemark17 compared anchorage

capacity of 4 anchorage systems namely onplant,
orthosystem implant, headgear, and transpalatal bar.
They found that stable anchorage was provided with
the onplant and the orthosystem implant. Headgear
anchorage was stable during the leveling/ aligning
phase but demonstrated anchorage loss at the end of
the observation period. The transpalatal bar provided
insufficient anchorage throughout the observation
period.
Madhur Upadhyay18 quantified treatment effects of enmasse retraction of anterior teeth with mini-implants
as anchor units and compared it with conventional
anchorage. Anchorage loss, in both the horizontal and
vertical directions, was noted in conventional
anchorage, whereas space closure with mini-implants
showed distalization and intrusion of molars. There was
no difference in mean retraction time.
RCTs in expansion
Thilander 19 in his RCT compared grinding and
expansion plates for correction of crossbite and
suggested that removal of premature contacts of the

RCTs in Treatment of Class III

Facemask with or without rapid palatal expansion was
compared. Subjects with Class III molar relationship
44

an Angle Class I anterior open bite. The results showed

no significant differences in the level of molar eruption
or in lower anterior face height, suggesting that the
vertical control expected from the chin cup therapy
did not occur. The dentoalveolar changes at the anterior
region of the dental arches were mainly responsible
for closure of the anterior open bite in patients treated
in the mixed dentition.

primary teeth is effective in preventing a posterior

crossbite from being perpetuated to the mixed dentition.
When grinding alone is not effective, using a removable
expansion plate to expand will decrease the risk of a
posterior crossbite from being perpetuated to the
permanent dentition. Banded or bonded slow maxillary
expansion were compared in an RCT by MossazJoelson,20 and they found no difference in the expansion
obtained when using either a bonded or banded slow
maxillary expansion appliance. The banded appliance
took longer to insert, and Oral hygiene was harder to
maintain for patients in the bonded group. Comparing
Quad helix and Expansion arch, McNally21suggested
that quadhelix and the expansion arch were equally
effective in producing expansion. There was some
evidence that the expansion arch was slightly more
reliable for producing expansion since the data for
quadhelix intercanine width increase are skewed.
Petrn and Bondemark22 in his RCT compared Quadhelix, expansion plate, composite onlay, and untreated
control. They said that if crossbite is planned to be
corrected in the mixed dentition treatment with the
quad-helix is an appropriate and successful method.
Treatment with the expansion plate was unsuccessful
in one third of the patients, and the reason was
insufficient patient cooperation. Crossbite correction
with composite onlay in the mixed dentition was not
effective.

RCTs in self ligation brackets

Scott26 compared the efficiency of mandibular tooth
alignment and the clinical effectiveness of a self-ligating
and a conventional preadjusted edgewise orthodontic
bracket system. He found no significant difference in
initial rate of alignment for either bracket system. Incisor
root resorption was not clinically significant and did
not differ between systems. Damon3 self-ligating
brackets are no more efficient than conventional ligated
preadjusted brackets during tooth alignment.
Fleming27 compared pain experience during Initial
Alignment with a Self-ligating bracket system
(SmartClip) and a Conventional appliance (Victory). He
found that bracket type had no effect on subjective
pain experience during the first week after initial
placement of archwire. Significantly greater discomfort
was experienced during archwire insertion and removal
with the SmartClip appliance.
RCTs on canine lace backs
Active ligation, Power chain and NiTi coil spring for
space closure were compared using RCT by Dixon28,
and showed that NiTi coil spring gave the most rapid
rate of space closure; Power chain can be considered
cheaper option as it is also effective. Slowest rate of
closure was seen when active ligatures were used.

RCTs in correcting Anterior open bite

Erbay23 compared Frnkels function regulator (FR-4)
appliance on the treatment of Angle Class I skeletal
anterior open bite malocclusion with untreated
controls. The results indicate that a spontaneous
downward and backward growth direction of the
mandible observed in the control group could be
changed to an upward and forward direction by FR-4
therapy.

Two RCTs compared anchorage loss of molars during

leveling with and without use of lacebacks. They
showed contradictory results. Usmani29 showed no
difference in anchorage loss of molars during leveling
in the upper jaw with or without laceback ligatures.
Irvine30 on the other hand, demonstrated a significant
larger anchorage loss when laceback ligatures were
used for leveling in the lower jaw.

Kiliaridis24compared posterior bite blocks with posterior

repelling magnet splints for correction of anterior open
bite. Dental and skeletal vertical relation responded
quickly to the magnet treatment. The open bite was
generally closed in just under 4 months, especially in
patients in early mixed dentition. Transverse problems,
i.e. unilateral cross-bite, sometimes followed by scissorbite on the opposite side were observed. The patients
who wore acrylic posterior bite-blocks also showed
improvement in the dental and skeletal vertical
relationships, especially during the first months. This
was followed by a plateau period. No transverse
problems were found in these patients.

RCT on sequlae of Extractions of lower primary canines

to relieve crowding
Kau31 in a RCT done to assess extraction of deciduous
canine as method to relieve crowding, randomly
allocated subjects to a primary canine non-extraction
or extraction group and were followed for 2 years. He
showed that crowding reduced 1.27 mm in the nonextraction group and 6.03 mm in the extraction group.
But arch perimeter decreased more in the extraction
group by 2.73 mm by molars moving forward

Torres25 compared Removable appliance with a palatal

crib with high-pull chin cup therapy in children with
45

RCT on Orthodontic archwire sequence

Mandall32 compared three different wire sequence
namely A = 0.016-inch nickel titanium (NiTi), 0.018
0.025-inch NiTi, and 0.019 0.025-inch stainless steel
(SS); B = 0.016-inch NiTi, 0.016-inch SS, 0.020-inch
SS, and 0.019 0.025-inch SS; and C = 0.016 0.022inch copper (Cu) NiTi, 0.019 0.025-inch CuNiTi,
and 0.019 0.025-inch SS. This trial showed that no
archwire sequence tested was more effective than
another, in terms of reported patient discomfort or upper
incisor root resorption or time taken to reach working
archwire. However, sequence B required statistically
significantly more visits, before the working archwire
was placed.

Nasal continuous positive airway pressure reduced the

apnea-hypopnea index and day time sleepiness more
than mandibular advancement device but the
difference was not significant. And mandibular
advancement device was better tolerated by the
patients. With acceptable efficacy and better
tolerability, mandibular advancement device is a
suitable alternative treatment for obstructive sleep
apnea
RCTs on Tempromandibular joint disorder
Keeling 38 assessed symptoms and signs of
temporomandibular disorders in children enrolled in
a randomized controlled trial of early treatment for Class
II malocclusion in University of Florida. He showed
early treatment with bionators and headgear/bite planes
did not place healthy children without these signs at
risk for developing these signs. Only increasing age
(for the development of sounds) and failure to achieve
a Class I molar relation (for development of muscle
pain) placed sign-free children at greater risk. This is in
contrast to the current consensus that not achieving a
specific gnathologic occlusal scheme does not increase
the risk of having TMD signs. Subjects with TMJ pain
at baseline were 7 times more likely to have pain at
follow-up if they had been treated with a headgear/
bite plane or observed than if they had been treated
with a bionator. These data from children are in
agreement with a review of the literature39 that recently
concluded that adult anterior repositioning splint
therapy appears to be superior to the flat-plane occlusal
splint in eliminating palpatory tenderness of the TMJ

RCT on Ion implantation of TMA archwires

Kula33 conducted a split-mouth randomized clinical
trial was used to determine whether ion implantation
of b-titanium archwire would facilitate sliding space
closure. 0.19 0.025-inch b-titanium archwires, ionimplanted on one half only, were placed. Nickeltitanium springs (150 g) were placed bilaterally to close
the extraction spaces. He found that median rates of
space closure were not significantly different between
the ion-implanted and the unimplanted sides.
RCT on Gingival offset brackets
Thind34 compared the clinical bond failure rate of
gingivally offset mandibular premolar brackets and
standard mandibular premolar brackets, and showed
that gingivally offset mandibular premolar brackets
have a lower bond failure rate than standard
mandibular premolar brackets.

Forssel 40 in his review of occlusal treatments in

temporomandibular disorders, found eight RCTs.
Based on these trials he concluded that occlusal splints
might be of some benefit in the treatment of TMD but
evidence for occlusal adjustment for management of
temporomandibular disorders is lacking. Further 7
RCTs were conducted to assess the effectiveness of
intra-articular injection of hyaluronate. Reviewers
found that long term effects (3 months) favor
hyaluronate for the improvement of clinical signs and
overall treatment of TMD, but mild and transient
adverse reactions such as discomfort or pain at the
injection site were reported.41

RCTs in Biology and Disorders

RCTS on Treatment for Obstructive sleep apnea
Johnston35 compared mandibular advancement devices
with placebo for correction of Obstructive Sleep Apnea
and reported that mandibular advancement devices
was more effective than placebo in reducing snoring,
reported daytime sleepiness and morning tiredness but
excessive salivation was the most common complaint.
Cooke and Battagel36 compared advanced and non
advanced thermoplastic mandibular advancement
devices and suggested that the advanced thermoplastic
mandibular advancement device is effective in the
treatment of snoring in two out of three non-apnoeic
snorers; their sleeping partners derive benefits from this
form of treatment

RCTs on Pain in Orthodontics

In a RCT comparing procedures recommended to
reduce pain, Otasevic42compared Bite-wafers where
immediate mastication of the wafers for 10 minutes,
and thereafter to bite on the wafers to prevent pain for
the next 7 days, was compared with Reducedmastication where patients were advised not to

Tan37 did RCT comparing Nasal continuous positive

airway pressure vs. mandibular advancement device.
46

masticate for 3 hours after placement of the fixed

appliance and to avoid masticating hard food for 7 days.
He found that more pain was reported by those using
bite wafers than by those who avoided masticatory
activity after placement of fixed appliances.

composite reinforced with plasma-treated polyethylene

ribbon retainers and reported that Ribbon reinforced
retainer (five out of ten retainers failed) while the multistrand wire retainer (one out of ten retainer failed)

Bradley43 compared 400 mg of oral ibuprofen or 1 g of

oral paracetamol an hour before and again 6 hours
after separator placement for control of orthodontic
pain. His trial found that a combination of preoperative
and postoperative ibuprofen is more effective than
paracetamol in the control of orthodontic pain.

Rowland 45 and Hichens 46 compared Hawley vs.

vacuum formed retainers, their clinical effectiveness,
cost-effectiveness and patient satisfaction. They
reported that Vacuum formed retainers are more
effective than Hawley retainers at holding the correction
of the maxillary and mandibular labial segments.
Vacuum formed retainers were more cost-effective than
Hawley retainers from all perspectives. The majority
of subjects showed a preference for Vacuum formed
retainers compared with Hawley retainers.

RCTs in Retaining devices

Rose 44 compared the reliability of 0.0175-inch
multistrand wire canine to canine retainers with resin

RCTs in Materials and Devices

Comparison

Remarks

Author

Band material
No difference in physico-chemical, mechanical,
toxicological properties, weld strength, tensile
strength

Valiathan et al 2000,47

Glass ionomer versus zinc

phosphate

No difference in bond failure, but less

decalcification when glass ionomer is used

Kvam 198349

Glass ionomer versus zinc

phosphate

Bond failure rate was similar for both cements

Stirrups 1991 BJO50

Glass ionomer versus light

cured compomers

No difference in bond failures and enamel

decalcification

Gillgrass 200151

Glass ionomer versus glass

polyphosphonate

Glass polyphosphonate performed as well as a

conventional GIC

Clark 200352

Light cured compomers versus

chemically cured resin
modified GIC

No difference in bond failure rates; taste more

acceptable for resin modified GIC

Williams 200553

Sodium fluoride mouth rinse

versus no mouth rinse

No difference in mineral loss between the

groups, but a significantly decreased lesion depth
in the experimental group

Ogaard, 198654

Antimicrobial varnish and a

Fluoride varnish and placebo
varnish

No differences between control and

experimental group in proportion of patients with
white spot lesions

Ogaard 200155

Resin modified GIC versus light

cured composite

No significant difference in the number of white

spots

Chung 1998,56

Chitra band material versus

Dentauram band material

Valiathan48

Cements for banding

Fluorides in orthodontics

47

Comparison

Remarks

Author

Fluorides in orthodontics (Contd.

GIC versus composite for
bonding

GIC quadrants had a significantly reduced

number of white spots

Marcusson 1997,57 Gorton

2003,58 Pascotto 200459

Fluoride releasing elastomeric

modules versus conventional
modules

Fluoride containing module reduced degree of

decalcification

Mattick 200160

Amine fluoride or Stannous

fluoride versus sodium fluoride
mouthrinses

Sodium fluoride mouthrinse had a slightly less

inhibiting effect on white spot lesion
development

Oggard et al 200661

Hydrophilic primer versus

conventional primer

Increased bracket failure rates with hydrophilic

primer

Littlewood 200162

Adhesive pre-coated versus

non pre-coated brackets

Pre-coated neither superior in bond failure nor

it decreases bracket bonding time

Wong and Power 200363

Direct and indirect bonding

Mean bracket placement errors were similar with

both techniques.

Hodge 200464

Plasma arc versus halogen

curing light

Plasma arc curing reduces the curing time of

orthodontic brackets without affecting the bond
failure rate.

Sfondrini 2004,65 Cacciafesta

2004,66 and Russel 200867

Self etching primer versus

conventional acid etch primer

No differences in bracket failure rates;

significantly shorter bracket bonding time

Aljubouri 2004, 68 Manning

200669

Self etching primer versus

conventional acid etch primer

Self-etching primer results in an unacceptably

high bond failure rate

Murfitt et al 2006,70 House et

al 200671

Bond enhancer (OrthoSolo)

versus conventional primer

Bond failure rate was similar in both the groups

Wenger 200872

Bonding

Conclusion
Certainly, there are circumstances that would prohibit
the use of an RCT, but the RCT still remains the strongest
method for comparing the efficacy of treatments. The
RCT is an unusually reliable method for learning from
experience. Its success comes from structuring that
experience so as to eliminate many of the sources of
ambiguity apparent in other research designs

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