This single-center 2-arm parallel randomized clinical trial aimed to compare the dentoskeletal effects of bonded spurs combined with posterior build-ups vs conventional bonded spurs in the treatment of anterior open bite malocclusion in the mixed dentition.
Patients aged from 7 to 11 years with anterior open bite, recruited at a university orthodontic clinic, were randomly allocated into 2 groups. The experimental group consisted of patients treated with bonded spurs combined with posterior build-ups. The comparison group comprised patients treated with conventional bonded spurs. Lateral headfilms were obtained at pretreatment and after 12 months of treatment. The primary outcome was the change in the overbite. Randomization was performed using the Web site www.randomization.com . Sequentially numbered opaque and sealed envelopes were used for allocation concealment. Blinding was applicable for outcome assessment only. Intergroup comparisons were performed using t or Mann-Whitney U tests ( P <0.05). Mean difference (MD) and 95% confidence interval (CI) were obtained.
The experimental group included 24 patients (17 female, 7 male; mean age, 8.22 ± 1.06 years) and the comparison group comprised 25 patients (14 female, 11 male; mean age, 8.30 ± 0.99 years). Baseline demographic and cephalometric characteristics were similar between groups. After 12 months, all patients showed improvements. Both groups showed similar improvements of the overbite (MD, 0.00 mm; 95% CI, −0.92 to 0.91), similar slight decreases of the gonial (MD, 0.02°; 95% CI, −1.11 to 1.15) and mandibular plane (MD, 0.15°; 95% CI, −0.64 to 0.93) angles, and similar mandibular molar extrusion (MD, 0.14 mm; 95% CI, −0.27 to 0.56). The experimental group showed significantly smaller extrusion of the maxillary first molar than the comparison group (MD, −0.70 mm; 95% CI, −0.92 to −0.49). The other dentoskeletal variables showed similar changes without statistically significant intergroup differences. No serious harm was observed other than plaque accumulation around the spurs.
Similar overbite increases and dentoskeletal changes were observed in both groups after 12 months of treatment. Although the experimental group showed significantly smaller extrusion of the maxillary molars, no greater counterclockwise rotation of the mandible than the comparison group was observed.
The protocol was not published.
This trial was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES), Finance Code 001; and by grants: no. 2017/06440-3, no. 2018/05238-9 and no. 2018/24003-2, São Paulo Research Foundation (FAPESP).
Two protocols for anterior open bite treatment in children were evaluated.
Treatment with spurs and posterior build-ups was compared with treatment with spurs alone.
Overbite increase was similar.
The experimental group showed smaller maxillary molar extrusion and similar counterclockwise rotation of the mandible.
Anterior open bite malocclusion is considered a challenge for orthodontists. , It affects esthetics and produces functional problems that could reflect in psychosocial issues. , Anterior open bite prevalence in the mixed dentition is approximately 17% and has a multifactorial etiology involving the interaction of environmental and genetic factors. , Environmental factors include deleterious habits such as using a pacifier, thumb sucking, tongue thrusting, and mouth breathing. , The greater the influence of environmental factors, the better will be the treatment prognosis because the causal factors are eliminated. ,
Several protocols have been proposed as early treatment and mostly focus on the interruption of deleterious habits allowing vertical dentoalveolar development of the anterior teeth without interferences. Among these protocols, bonded spurs have been reported to show advantages of low cost, small size, esthetics, no need for laboratory preparation, easy installation, and reduced chair time. Lingual spurs effectively correct the anterior open bite by keeping tongue pressure away from the anterior teeth and as a reminder to cease other oral habits. Their effects include extrusion and palatal and lingual tipping of the maxillary and mandibular incisors, respectively.
Anterior open bite is commonly related to a vertical growth pattern and an increase in the lower anterior face height. , , Thus, some protocols have combined therapies that correct the habits and control the vertical dimension. Bonded spurs combined with chincup demonstrated efficiency in open bite correction , and a significant decrease of the gonial angle. However, chincup success depends on patient compliance.
The use of posterior build-ups combined with orthodontic fixed appliances for anterior open bite treatment in adults has been reported as a practical, efficient, and stable treatment option that provides counterclockwise rotation of the mandible because of the bite-block effect. Therefore, the combination of bonded spurs with posterior build-ups can produce vertical control during anterior open bite early treatment. Nevertheless, no studies evaluating this combination has been reported.
Although some systematic reviews mentioned the need for well performed randomized clinical trials (RCT) on this topic, , , , only 2 RCT evaluated the effects of bonded spurs in the last years. , However, they did not include a combined therapy in their comparisons. Thus, the present study would bring information on the effectiveness of the proposed combined therapy for open bite early treatment.
Specific objectives or hypotheses
This study aimed to compare the dentoskeletal changes of bonded spurs combined with posterior build-ups vs conventional bonded spurs in anterior open bite early treatment. The null hypothesis tested was that both therapies produce similar dentoskeletal effects.
Trial design and any changes after trial commencement
This project was a single-center RCT with 2 parallel arms and a 1:1 allocation ratio. This RCT followed the Consolidated Standards of Reporting Trials statement and guidelines, and did not require changes in methods after trial commencement.
Participants, eligibility criteria, and settings
This study was approved by the Ethics in Research Committee of Bauru Dental School, University of São Paulo, Bauru, Brazil (protocol no. 68551617.8.0000.5417/2.112.035). In addition, the protocol of this study was registered at Clinicaltrials.gov with the identifier NCT03702881 .
Patients were recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Bauru, Brazil, from June 2017 to April 2018. The selection criteria included patients aged between 7 and 11 years, anterior open bite >1 mm (clinically evaluated as the vertical distance between the incisal edges of the maxillary and mandibular central incisors), erupted permanent first permanent molars, with the maxillary and mandibular permanent central incisors fully erupted, without or with only mild crowding, and without the need of maxillary expansion. To differentiate between incomplete eruption and open bite for the younger patients, we considered the vertical relationship between lateral and central incisors. If the maxillary lateral incisors were closer to the occlusal plane than the maxillary central incisors and these central incisors still showed a negative overbite greater than 1 mm, the condition was classified as an open bite. This method was adopted on the basis of previous studies. , , Children with previous orthodontic treatment, craniofacial anomalies or syndromes, tooth agenesis, loss of permanent teeth, severe crowding, maxillary constriction, or posterior crossbite were excluded.
Informed consent was obtained from the patients and their parents or legal guardians before recruitment.
Bonded spurs (Morelli Ortodontia, Sorocaba, São Paulo, Brazil) were installed at the cervical and incisal regions of the palatal and lingual surfaces of the maxillary and mandibular incisors, respectively. These regions were selected to prevent possible occlusal interferences during treatment. , The spurs were bonded using the Transbond XT light cure orthodontic adhesive (3M Unitek, Monrovia, Calif). The spurs were sharpened with a carborundum disk before bonding.
The experimental group comprised patients treated with bonded spurs combined with posterior build-ups. Posterior build-ups consisted of 2-3 mm resin blocks of light-cured orthodontic cement (Ortho Bite; FGM, Joinville, Santa Catarina, Brazil) bonded on the palatal cusps of all maxillary posterior teeth to maintain the natural occlusal force balance ( Fig 1 , A ). The maxillary molars were chosen on the basis of a previous study, and because of the facility for relative isolation. Posterior build-ups wore down in a few patients (4 of 25) and were rebuilt only once during treatment. The comparison group comprised patients treated with only bonded spurs ( Fig 1 , B ). The treatment follow-up was 12 months, as previously reported for similar studies. , , Posterior build-ups were removed in the experimental group before obtaining the second digital lateral headfilms (which were taken on the same day). Bonded spurs were maintained as active retention in both groups.
Digital lateral headfilms were obtained using Orthophos XG 3D (Dentsply Sirona, Bensheim, Germany) at pretreatment and after 12 months of treatment for all patients.
Outcomes (primary and secondary) and any changes after trial commencement
The change in the overbite was considered as the primary outcome measurement.
Secondary outcome measurements included the changes in the gonial angle, mandibular plane angle, lower anterior face height, inclination/position/height of the maxillary and mandibular incisors, and maxillary and mandibular molar extrusion.
All measurements ( Table I ) were performed using Dolphin Imaging software (version 11.5; Dolphin Imaging and Management Solutions, Chatsworth, Calif).
|Ar.Go.Me, °||ArGo to GoMe angle|
|SN.GoGn, °||SN to GoGn angle|
|LAFH, mm||Anterior nasal spine to menton distance|
|Overbite, mm||Distance between incisal edges of maxillary and mandibular central incisors, perpendicular to occlusal plane|
|Maxillary dentoalveolar component|
|Mx1.NA, °||Maxillary incisor long axis to NA angle|
|Mx1-NA, mm||Distance between most anterior point of crown of maxillary incisor and NA line|
|Mx1-PP, mm||Perpendicular distance between incisal edge of maxillary incisor and palatal plane|
|Mx6-PP, mm||Perpendicular distance between mesial cusp of maxillary first permanent molar and palatal plane|
|Mandibular dentoalveolar component|
|Md1.NB, °||Mandibular incisor long axis to NB angle|
|Md1-NB, mm||Distance between most anterior point of crown of mandibular incisor and NB line|
|Md1-GoMe, mm||Distance between incisal edge of mandibular incisor and mandibular plane|
|Md6-GoMe, mm||Distance between mesial cusp of mandibular first permanent molar and mandibular plane|
The anterior open bite was considered corrected when the overbite was equal or greater than 0 (0 meaning an end-to-end vertical incisor relationship), cephalometrically confirmed as the distance in millimeters between the incisal edges of the maxillary and mandibular central incisors, perpendicular to the occlusal plane. , There were no outcome changes after trial commencement.
Sample size calculation
The sample size was calculated to provide 80% of test power at a significance level of 0.05 to detect an intergroup difference of 1.5 mm in the overbite with a previously reported standard deviation of 1.69 mm. The minimal sample size required per group was 21 patients.
Interim analyses and stopping guidelines
Randomization (random number generation, allocation concealment, implementation)
The randomization scheme was obtained by using the Web site Randomization.com ( www.randomization.com ). This software generated the randomization list using random block sizes, ensuring equal distribution in both groups. Fifty patients were randomized before trial commencement.
Allocation concealment was achieved with sequentially numbered opaque and sealed envelopes containing the treatment allocation cards. Opacity was implemented by inserting the card with the assignment into the foil. The envelopes were prepared before the trial commencement. The patient’s name and baseline information were written on the envelope before opening it. All envelopes were torn open instead of being unsealed. The envelopes were securely stored in a different location from the trial site.
The generation of randomization lists, allocation concealment, and implementation (enrollment of participants/treatment assignment/deliver intervention) were performed independently by different persons.
Blinding of either patient or operator was not possible because both knew the type of appliance installed. However, the assessment of the lateral radiographs was blinded. All radiographs were unidentified before the assessor’s evaluation, and all those taken at T2 showed the presence of bonded spurs and the absence of posterior build-ups.
Statistical analyses (primary and secondary outcomes, subgroup analyses)
Lateral headfilms of 30% of the sample were randomly selected and retraced by the same examiner after a 30-day interval. Intraobserver reliability was assessed with the intraclass correlation coefficient.
Normal distribution was tested using the Shapiro-Wilk test. Sex distribution was compared with the Fisher exact test. Intergroup comparisons regarding age and cephalometric variables were performed with t or Mann-Whitney U tests, depending on normality. The influence of pretreatment predictor variables (Ar.Go.Me, SN.GoGn, LAFH, and the initial amount of anterior open bite) on the overbite change was evaluated with multiple linear regression analysis considering all patients. Statistical analyses were performed using SPSS software (version 25; IBM, Armonk, NY). Results were considered significant at P <0.05.
A total of 1025 children were assessed for eligibility; 969 were excluded because they did not meet the inclusion criteria, and 6 declined to participate. Fifty patients were randomized in a 1:1 ratio ( Fig 2 ).
|Variable||Experimental group (n = 24)||Comparison group (n = 25)||P value|
|Age, y, mean (SD)||8.22 (1.06)||8.30 (0.99)||0.787 ∗|
|Sex, n (%)|
|Female||17 (70.8)||14 (56.0)||0.377 †|
|Male||7 (29.2)||11 (44.0)|
|Variable||Experimental group (n = 24)||Comparison group (n = 25)|
|Maxillary dentoalveolar component|
|Mandibular dentoalveolar component|