Dataset Information

Outcome and comparator choice in molar incisor hypomineralisation (MIH) intervention studies: a systematic review and social network analysis.

ABSTRACT:

Objectives

Outcome and comparator choice strongly determine the validity and implementation of clinical trial results. We aimed to assess outcome and comparator choice in intervention studies on molar incisor hypomineralisation (MIH) using systematic review and social network analysis (SNA).

Design and data sources

Medline, Embase, Cochrane Central, Google Scholar, opengrey.eu as well as DRKS.de and Clinicaltrials.gov were searched for MIH intervention studies. The search covered the period from 1980 to 2019.

Eligibility criteria

Clinical single-arm/multiarm, controlled/uncontrolled studies reporting on the management of MIH were included. Reported outcomes and comparators were extracted and categorised. SNA was used to evaluate comparator choice and the resulting trial networks.

Data extraction

Of the 7979 identified records, 100 were evaluated in full text and 35 studies (17 randomised controlled trials, 14 prospective and 4 retrospective cohort studies) were included.

Results

In total, 2124 patients with a mean age of 11 years (min/max 6/70 years) were included. Outcomes fell in one of 11 different outcome categories: restoration success, aesthetic improvement, pain/hypersensitivity/discomfort, mineral gain, space management, anaesthesia effectiveness, preventive success, efficiency, quality of life, gingival and periodontal health and patient satisfaction. Comparators were mainly restorative interventions (17 studies), remineralisation (3), treatment of hypersensitivity (10), aesthetic interventions (5) and orthodontic interventions (3). Two highly clustered comparator networks emerged; many interventions were not robustly linked to these networks.

Conclusions

MIH intervention studies recorded both clinically centred and patient-centred outcomes. Core outcome set development should consider these and supplement them with outcomes on, for example, applicability. The high number of compared interventions tested in only few studies and our SNA results implicate that the current evidence may not be robust.

SUBMITTER: Elhennawy K

PROVIDER: S-EPMC6687020 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Outcome and comparator choice in molar incisor hypomineralisation (MIH) intervention studies: a systematic review and social network analysis.

Elhennawy Karim K Krois Joachim J Jost-Brinkmann Paul-Georg PG Schwendicke Falk F

BMJ open 20190802 8

<h4>Objectives</h4>Outcome and comparator choice strongly determine the validity and implementation of clinical trial results. We aimed to assess outcome and comparator choice in intervention studies on molar incisor hypomineralisation (MIH) using systematic review and social network analysis (SNA).<h4>Design and data sources</h4>Medline, Embase, Cochrane Central, Google Scholar, opengrey.eu as well as DRKS.de and Clinicaltrials.gov were searched for MIH intervention studies. The search covered ...[more]

PMID: 31377700

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Project description:All children, who were born in 2004 and had undergone surgical treatment for recurrent acute tonsillitis and/or acute otitis media at the ear, nose and throat clinic (ENT) between 2004 and 2010, were called on dental examination and blood sampling. Out of 441 invitees, 113 children and their parents/legal guardians agreed to participate. The following data from this group of subjects are presented: the presence of clinical signs of molar-incisor hypomineralisation (MIH), the distribution of human leukocyte antigen (HLA) alleles DQ2 and DQ8 and eight single nucleotide polymorphisms (SNPs) located in amelogenesis-related genes (rs3796704 in the ENAM gene, rs546778141 in the AMBN gene, rs2106416 in the AMELX gene, rs7660807 and rs35286445 in the AMTN gene, rs4870723 in the COL14A1 gene, rs2245803 in the MMP20 gene, and rs3828054 in the TUFT1 gene). Data on clinical signs of MIH were collected in accordance with the recommendation and on the proposed MIH clinical data recording sheet [1], and with appropriate preliminary training and calibration. Data on HLA DQ2 and DQ8 haplotypes and on SNPs of amelogenesis-related genes were obtained using DNA isolated from blood samples taken from subjects. The HLA DQ2 and DQ8 alleles were determined using the EliGene® Coeliac RT Kits (90,048-RT; Elisabeth Pharmacon spol. s.r.o., Brno-Židenice, Czech Republic) on a 7500 Fast RT-PCR System (Applied Biosystems, Waltham, MA, USA). The distributions of SNPs in the amelogenesis-related genes were determined using high resolution melting (HRM) using the Type-IT HRM Master Mix (Qiagen), TaqMan genotyping assays (ID: C__25766207_10; Thermo Fisher Scientific, Waltham, MA, USA) with the TaqMan Universal Master Mix II, or Sanger sequencing using sequencing master mix BigDye® Terminator v3.1 (Applied Biosystems) and ABI 3500 Genetic Analyser (Applied Biosystems). L. Hočevar, J. Kovač, K. Trebušak Podkrajšek, S. Battelino, A. Pavlič, 2020. The possible influence of genetic aetiological factors on molar-incisor hypomineralisation, Arch. Oral. Biol. 118, 104848. https://doi.org/10.1016/j.archoralbio.2020.104848.

Project description:IntroductionMolar 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 analysisPatients 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 χ2 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 disseminationThis 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 numberNCT05443035.

Dataset Information

Outcome and comparator choice in molar incisor hypomineralisation (MIH) intervention studies: a systematic review and social network analysis.

Objectives

Design and data sources

Eligibility criteria

Data extraction

Results

Conclusions

Publications

Outcome and comparator choice in molar incisor hypomineralisation (MIH) intervention studies: a systematic review and social network analysis.

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