Core Outcome Measures in Effectiveness Trials

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

General Information

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, as well as and 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.

Elhennawy, K. Krois, J. Jost-Brinkmann, P. G. Schwendicke, F.


BMJ Open
e028352 -
Further Study Information

Funding source(s):
The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Health Area

Disease Category
Dentistry & oral health

Disease Name
Molar Incisor Hypomineralization (MIH)

Target Population

Age Range
6 - 60


Nature / type of Intervention


Systematic review

Stakeholders Involved


Study Type

Systematic review of outcomes measured in trials

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