2.1

Eligibility criteria

This systematic review (registered at PROSPERO CRD42016039677) included clinical trials

• •

  on human subjects having a minimum of one permanent first molar with MIH (with or without affection of one or more incisor) in need of any, i.e. preventive, restorative, endodontic, surgical and/or orthodontic, treatment. Note that the decision as to if a treatment was needed could have been made subjectively; we did not predefine criteria how such need was decided. Given the wide range of treatment modalities, we expected a range of lesion severities and symptomatologies to be included.

• •

  reporting on minimum one such treatment, which means that studies could be retrospective or prospective, controlled trials or cohort studies.

• •

  with a minimum sample size of 10 to exclude small case series, as any inference as to how well a treatment truly performs based on such small sample sizes is unlikely to be robust

• •

  reporting on the “performance” of the provided treatment, as described below.

Consequently, case reports or small case series, studies describing a treatment method without reporting any results, review articles or non-clinical studies were excluded.

2.2

Outcomes

The primary outcome was the “success” of a treatment, i.e. the proportion of teeth and/or patients where the treatment did not need repeating or other re-interventions. Success captures a range of complications, like enamel breakdown, caries occurrence, restoration failure, pain needing endodontic treatment, or the proportion of cases requiring orthodontic alignment after extraction (i.e. without spontaneous alignment).

Preventive treatments, like fluoride varnishes, are oftentimes repeated in a planned manner without this being considered a “failure”. Therefore, success was defined as the proportion of teeth or patients, which did not require further (restorative, endodontic, surgical) interventions for these treatments.

The secondary outcomes were

• •

  adverse events (like allergies towards a used material)

• •

  treatment costs or efforts (required time, materials)

• •

  subjective evaluations by patients, parents, or dentists.

We have not specified upfront how outcomes needed to be reported (on binary, ordinal or continuous scale etc.).

2.3

Information sources and study selection

We searched Medline via PubMed, Embase via Ovid, Cochrane Central and Google Scholar. Moreover, opengrey.eu was searched to identify accepted, but not published studies. In addition, reference lists of identified full texts were screened and cross-referenced. We contacted study authors if required to obtain full texts. The search covered a period from January 1, 1980, to May 1, 2016. Neither authors nor journals were blinded to reviewers. No language restriction was set; studies in languages other than English or German were translated by native speakers.

2.4

Search strategy

The following search was adapted for each database:

((((((((((((((((((mottled enamel) OR non endemic mottling of enamel) OR internal enamel hypoplasia) OR cheese molars) OR non-fluoride enamel opacities) OR idiopathic enamel opacities) OR enamel hypomineralization) OR enamel hypomineralisation) OR hypomineralized molars) OR hypomineralized molars) OR molar incisor hypomineralization) OR molar incisor hypomineralisation) OR molar-incisor hypomineralization) OR molar-incisor hypomineralisation) OR molar-incisor-hypomineralization) OR molar-incisor-hypomineralisation) OR mih)) AND ((((((management) OR treatment) OR orthodontics) OR extraction) OR first permanent molar) OR clinical).

2.5

Selection process

Both authors (FS, KE) independently screened titles and then compared their findings. In the case of disagreement, titles were included to obtain full texts. Full texts were assessed independently after de-duplication. Studies were included after agreement with a consensus in cases of disagreement being reached through discussion.

2.6

Data collection process

A pilot-tested spreadsheet was used for data extraction, which was performed independently by both reviewers (FS, KE). No disagreements occurred.

2.7

Data items

The following items were collected: Author names, year of publication, sample size, sample characteristics, type of intervention, drop-out rate, results and risk of bias.

2.8

Outcomes

The study findings for our primary and secondary outcomes and outcome measures were extracted. For studies reporting non-significant findings without any further information, this was extracted to potentially allow sensitivity meta-analysis (which was eventually not possible).

2.9

Quantitative synthesis

The synthesis was performed for annual failure rates in restorative trials. For other groups of treatments, pooling of data was not possible or needed as only one intervention was investigated. The unit of analysis was the tooth; clustering is thus possible and standard deviations of pooled failure rates are likely wider than estimated. As we did not aim to statistically compare rates (given the low number of studies supporting each intervention), this was accepted. Annual failure rates were sample size weighted for pooling.

2.10

Risk of bias

For controlled trials, Cochrane’s risk of bias tool was originally planned to be used. As most studies were observational in character, the Newcastle-Ottawa scale (NOS) was instead used for risk of bias assessment of all trials , evaluating selection and comparability of cohorts, assessment of outcomes and exposure ascertainment. NOS scores of 0–5 were assumed to indicate a high risk of bias, while 6–7 indicated moderate and 8 low risks of bias.

2.1

Eligibility criteria

This systematic review (registered at PROSPERO CRD42016039677) included clinical trials

• •

  on human subjects having a minimum of one permanent first molar with MIH (with or without affection of one or more incisor) in need of any, i.e. preventive, restorative, endodontic, surgical and/or orthodontic, treatment. Note that the decision as to if a treatment was needed could have been made subjectively; we did not predefine criteria how such need was decided. Given the wide range of treatment modalities, we expected a range of lesion severities and symptomatologies to be included.

• •

  reporting on minimum one such treatment, which means that studies could be retrospective or prospective, controlled trials or cohort studies.

• •

  with a minimum sample size of 10 to exclude small case series, as any inference as to how well a treatment truly performs based on such small sample sizes is unlikely to be robust

• •

  reporting on the “performance” of the provided treatment, as described below.

Consequently, case reports or small case series, studies describing a treatment method without reporting any results, review articles or non-clinical studies were excluded.

2.2

Outcomes

The primary outcome was the “success” of a treatment, i.e. the proportion of teeth and/or patients where the treatment did not need repeating or other re-interventions. Success captures a range of complications, like enamel breakdown, caries occurrence, restoration failure, pain needing endodontic treatment, or the proportion of cases requiring orthodontic alignment after extraction (i.e. without spontaneous alignment).

Preventive treatments, like fluoride varnishes, are oftentimes repeated in a planned manner without this being considered a “failure”. Therefore, success was defined as the proportion of teeth or patients, which did not require further (restorative, endodontic, surgical) interventions for these treatments.

The secondary outcomes were

• •

  adverse events (like allergies towards a used material)

• •

  treatment costs or efforts (required time, materials)

• •

  subjective evaluations by patients, parents, or dentists.

We have not specified upfront how outcomes needed to be reported (on binary, ordinal or continuous scale etc.).

2.3

Information sources and study selection

We searched Medline via PubMed, Embase via Ovid, Cochrane Central and Google Scholar. Moreover, opengrey.eu was searched to identify accepted, but not published studies. In addition, reference lists of identified full texts were screened and cross-referenced. We contacted study authors if required to obtain full texts. The search covered a period from January 1, 1980, to May 1, 2016. Neither authors nor journals were blinded to reviewers. No language restriction was set; studies in languages other than English or German were translated by native speakers.

2.4

Search strategy

The following search was adapted for each database:

((((((((((((((((((mottled enamel) OR non endemic mottling of enamel) OR internal enamel hypoplasia) OR cheese molars) OR non-fluoride enamel opacities) OR idiopathic enamel opacities) OR enamel hypomineralization) OR enamel hypomineralisation) OR hypomineralized molars) OR hypomineralized molars) OR molar incisor hypomineralization) OR molar incisor hypomineralisation) OR molar-incisor hypomineralization) OR molar-incisor hypomineralisation) OR molar-incisor-hypomineralization) OR molar-incisor-hypomineralisation) OR mih)) AND ((((((management) OR treatment) OR orthodontics) OR extraction) OR first permanent molar) OR clinical).

2.5

Selection process

Both authors (FS, KE) independently screened titles and then compared their findings. In the case of disagreement, titles were included to obtain full texts. Full texts were assessed independently after de-duplication. Studies were included after agreement with a consensus in cases of disagreement being reached through discussion.

2.6

Data collection process

A pilot-tested spreadsheet was used for data extraction, which was performed independently by both reviewers (FS, KE). No disagreements occurred.

2.7

Data items

The following items were collected: Author names, year of publication, sample size, sample characteristics, type of intervention, drop-out rate, results and risk of bias.

2.8

Outcomes

The study findings for our primary and secondary outcomes and outcome measures were extracted. For studies reporting non-significant findings without any further information, this was extracted to potentially allow sensitivity meta-analysis (which was eventually not possible).

2.9

Quantitative synthesis

The synthesis was performed for annual failure rates in restorative trials. For other groups of treatments, pooling of data was not possible or needed as only one intervention was investigated. The unit of analysis was the tooth; clustering is thus possible and standard deviations of pooled failure rates are likely wider than estimated. As we did not aim to statistically compare rates (given the low number of studies supporting each intervention), this was accepted. Annual failure rates were sample size weighted for pooling.

2.10

Risk of bias

For controlled trials, Cochrane’s risk of bias tool was originally planned to be used. As most studies were observational in character, the Newcastle-Ottawa scale (NOS) was instead used for risk of bias assessment of all trials , evaluating selection and comparability of cohorts, assessment of outcomes and exposure ascertainment. NOS scores of 0–5 were assumed to indicate a high risk of bias, while 6–7 indicated moderate and 8 low risks of bias.

3.1

Study selection

From 2420 identified studies, 64 were evaluated full text, and 14 clinical trials included ( Fig. 1 , Tables 1 and 2 ). Excluded studies and reasons for exclusion can be found in the appendix (Table S1).

Flow-chart of the study.

Table 1

Included studies on treatments in molars (studies ordered chronologically).

Author/s	Type	N	Age (y)	Gen	Nt	Severity	Intervention	Follow-up (m)	Results
Koch and Garcia- Godoy [2000]	Pro Co	12	6–8	n/a	41	n/a	4 composite crowns 8 ceramic crowns 29 gold crowns	24–60	41/41 (100%) success
Lygidakis et al. [2003]	Pro Co	46	8–10	n/a	49	Severe	Composite (18 two surfaces, 31 three surfaces)	48	49/49 (100%) success
Zagdwon et al. [2003]	RCT	17	6–16	6 M, 11 F	42	Severe	(A) 19 PMC (B) 23 adhesive casts	12–24	(A) 18/19 (94.7%) success (B) 21/23 (91.3%) success Adhesive casts 4 times more expensive than PMCs
Kotsanos et al. [2005]	Retro Co	72	8	38 M, 34 F	136	n/a	(A) 35 sealants (B) 18 amalgam (C) 59 composite (D) 24 PMC	52	(A) 87.1% success (B) 38.9% success (C) 74.6% success (D) 100% success
Mejare et al. [2005]	Retro Co	76	6–17	31 M, 45 F	153	Mild and severe	(A) 63 GIC (B) 14 compomer (C) 34 composite (D) 32 amalgam (E) 1 PMC (F) 9 castings	62	(A) 49.2% success (B) 64.3% success (C) 85.3% success (D) 78.1% success (D) 100% success (F) 100% success 5/153 with pulp necrosis (unclear in which groups)
Jälevik and Möller [2007]	Retro Co	27	6–13	15 M, 18 F	70	Severe	Extraction with or without orthodontics	44–99	Maxilla: 22/40 tooth (55%) space closure without intervention (success) Mandible: 14/30 tooth (47%) space closure without intervention (success)
Lygidakis et al. [2009]	RCT	47	6–7	n/a	94	Mild	(A) Adhesive + FS (B) Conventional FS	48	(A) 33/47 (70.3%) success; 14/47 (29.7%) partially sealed (failure) (B) 12/47 (25.5%) success; 21/47 (44.6%) partially sealed (failure); 14/47 (29.7%) complete loss (failure)
Baroni and Marchionni [2011]	Pro Co	30	6–9	n/a	30	n/a	CPP-ACP	36	Improvement in the enamel morphology
Gaardmand et al. [2013]	Retro Co	33	8–18	17 M, 16 F	57	Severe	Cast adhesive gold copings	Mean 38.6	56/57 (98.2%) success
Fragelli et al. [2015]	Pro Co	21	6–9	12 M, 9 F	48	Severe	GIC	12	15/21 (78%) success

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