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Functional therapy and adenotonsillectomy clinical trial for class II malocclusion (FACT-II): protocol for a randomised controlled trial

Por: Guo · F. · Lv · C. · Tang · B. · Lin · L. · Zhang · C. · Zheng · J. · Zhao · T. · He · H.
Introduction

Class II malocclusion with mandibular retrognathia is a common complication of paediatric obstructive sleep apnoea (OSA), often accompanied by transverse maxillary deficiency. In early orthodontic treatment, a twin block (TB) is a regular functional appliance for correcting this malocclusion. For paediatric OSA, the most common risk factor is adenotonsillar hypertrophy (AHT). Untreated AHT may lead to the persistence and worsening of obstructive sleep-disordered breathing traits, including habitual mouth breathing. Additionally, the clockwise mandibular rotation associated with AHT-induced pharyngeal crowding can undermine the effectiveness and stability of TB treatment. Adenotonsillectomy (T&A) is currently the first-line treatment for paediatric OSA. This proposed trial will investigate the impact of T&A surgery timing on the efficacy and stability of TB functional treatment in children with class II mandibular retrognathia and ATH.

Methods and analysis

This will be a single-centre, parallel-group, superiority randomised controlled trial with participants randomised to intervention (T&A followed by TB treatment) or control arms (TB treatment followed by T&A) in a 1:1 ratio. A total of 40 patients aged 8–14 years, diagnosed with class II mandibular retrognathia and co-existing ATH-induced OSA, and indicated for both T&A surgery and TB treatment, will be recruited at the School and Hospital of Stomatology, Wuhan University. The primary outcomes will be the changes in the apnoea-hypopnoea index and the point A-nasion-point B angle from baseline to postorthodontic treatment between the two groups. Secondary outcomes will include other dental, skeletal, upper airway and soft tissue changes, as well as subjective sleep-related and oral-related quality of life. Outcome changes within each group and between groups will be analysed.

Ethics and dissemination

This study is approved by the Ethics Committee of the School and Hospital of Stomatology, Wuhan University (no. 2022-D07). The research findings will be faithfully disseminated through scientific conferences or published articles.

Trial registration number

ChiCTR2200061703 (https://www.chictr.org.cn).

Predictive factors for the treatment success of peri-implantitis: a protocol for a prospective cohort study

Por: Zhu · Y. · Lu · H. · Yang · S. · Liu · Y. · Zhu · P. · Li · P. · Waal · Y. C. M. D. · Visser · A. · Tjakkes · G.-H. E. · Li · A. · Xu · S.
Introduction

Peri-implantitis, a common biological complication of dental implant, has attracted considerable attention due to its increasing prevalence and limited treatment efficacy. Previous studies have reported several risk factors associated with the onset of peri-implantitis (eg, history of periodontitis, poor plaque control and smoking). However, inadequate data are available on the association between these risk factors and successful outcome after peri-implantitis therapy. This prospective cohort study aims to identify the local and systemic predictive factors for the treatment success of peri-implantitis.

Methods and analysis

A single-centre cohort study will be conducted by recruiting 275 patients diagnosed with peri-implantitis. Sociodemographic variables, healthy lifestyles and systemic disorders will be obtained using questionnaires. In addition, clinical and radiographic examinations will be conducted at baseline and follow-up visits. Treatment success is defined as no bleeding on probing on more than one point, no suppuration, no further marginal bone loss (≥0.5 mm) and probing pocket depth ≤5 mm at the 12-month follow-up interval. After adjustment for age, sex and socioeconomic status, potential prognostic factors related to treatment success will be identified using multivariable logistic regression models.

Ethics and dissemination

This cohort study in its current version (2.0, 15 July 2022) is in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Stomatological Hospital, Southern Medical University (EC-CT-(2022)34). The publication will be on behalf of the study site.

Trial registration number

ChiCTR2200066262.

Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Por: Mandetta · A. R. H. · Bortoletto · C. C. · Sobral · A. P. T. · Goncalves · M. L. L. · Motta · L. J. · Horliana · A. C. R. T. · Ferrari · R. A. M. · Prates · R. A. · Deana · A. M. · Cordeiro · R. d. C. L. · Pinto · L. A. M. d. S. · Fernandes · K. P. S. · Bussadori · S. K.
Introduction

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Methods and analysis

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the 2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

Trial registration number

NCT05443035.

Efficacy of a modified twin block appliance compared with the traditional twin block appliance in children with hyperdivergent mandibular retrognathia: protocol for a single-centre, single-blind, randomised controlled trial

Por: Liu · A. · Zhang · W. · Zhang · W. · Shi · S. · Chen · Z. · Liu · Y. · Lu · Y.
Introduction

Compensatory mouth breathing, caused by nasopharyngeal obstructive diseases, is the main cause of hyperdivergent mandibular retrognathia in children. Such deformities require effective growth guidance before pubertal growth peaks. The traditional mandibular advancement device, twin block (TB), can guide the forward development of the mandible. However, the side effect of increasing the vertical dimension of the lower facial third, worsens the facial profile of children with divergent growth trends. To solve this problem, a modified TB (LLTB) appliance was designed to control the vertical dimension by intruding incisors and inhibiting the elongation of posterior teeth during the advancement of the mandible, which could avoid the side effects of traditional appliances and effectively guide the growth of the mandible in a normal direction.

Methods and analysis

The study was designed as a single-centre, single-blind, randomised, parallel controlled trial. We aim to enrol 60 children aged 9–14 years with hyperdivergent skeletal class II malocclusion, using a 1:1 allocation ratio. The participants were will be randomly assigned to receive either the TB or LLTB treatment. The primary outcome will be a change in the angle of the mandibular plane relative to the anterior cranial base. The secondary outcomes will include changes in the sagittal maxillomandibular relation, occlusal plane, facial height, morphology of the mandible and upper airway width. Safety endpoints will also be evaluated.

Ethics and dissemination

Ethical approval was obtained from the ethics committee of Shanghai Stomatological Hospital. Both participants and their guardians will be fully informed of the study and sign an informed consent form before participating in the trial. The results will be publicly available in peer-reviewed scientific journals.

Trial registration number

ChiCTR2000035882.

Association between the number of teeth and incident pre-diabetes among middle-aged adults with periodontal disease: a retrospective cohort analysis of Japanese claims data

Por: Hasegawa · K. · Sakurai · A. · Mizuki · M. · Kurita · H. · Tsukahara · T. · Nomiyama · T.
Objectives

To investigate the association between the number of teeth and the new onset of pre-diabetes.

Design

Retrospective cohort study.

Setting

The National Database of Health Insurance Claims and Specific Health Checkups of Japan, which holds information from both the yearly health check-up programme known as the ‘Specific Health Checkup’ and health insurance claims data.

Participants

1 098 371 normoglycaemic subjects who participated in the Specific Health Checkup programme every year from fiscal year (FY) 2015 to FY 2018 and had dental insurance claims data with a diagnosis of periodontal disease during FY 2016.

Outcome measures

Incidence of pre-diabetes or diabetes observed at the Specific Health Checkup during FY 2018.

Results

Among the participants, 1 77 908 subjects developed pre-diabetes, and 579 developed diabetes at the check-up during the subsequent follow-up year. Compared with the subjects with 26–28 teeth, those with 20–25, 15–19 or 1–14 teeth were associated with an increased likelihood of developing pre-diabetes or diabetes onset with adjusted ORs of 1.03 (95% CI: 1.02 to 1.05), 1.06 (1.03 to 1.09) and 1.07 (1.04 to 1.11), respectively. No clear modifications were observed for age, sex, body mass index or current smoking.

Conclusions

Having fewer teeth was associated with a higher incidence of pre-diabetes. Due to the limitations of this study, however, causality remains undetermined.

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