CRITICAL APPRAISAL OF INCLUDED PUBLICATIONS

First Author, Publication
Year, Study Design,
Comparators

Strengths

Limitations

Space maintainer (SM) vs. none:

Alnahwi¹¹ 2015

Observational

SM (mix of band and loop, lower lingual holding arch, transpalatal arch, and Nance holding appliance) vs. No SM

Long follow-up period (up to 48 months)
Defined inclusion/exclusion criteria
Defined outcomes

Did not describe recruitment
Did not account for confounding
Grouped different appliances, which may have different treatment effects into one comparator; did not report the proportion of each SM type used
Included patients who had SM applied years after primary second molar extraction
Small sample size
Single centre

Letti¹² 2013

Observational

Lingual arch appliance vs. No SM

Used commonly accepted cephalometric analyses to measure outcomes

Did not describe recruitment
Did not account for confounding
Reported a study error in the outcome measurements; measurements were taken again and no significant differences were found (Student’s t test, p> 0.05)
Results did not support conclusions
Poor reporting overall
Single centre

Comparisons of different types of SM to each other:

Setia⁷ 2014

CCT

Band and loop vs. Band and custom loop vs. Ribbond vs. Super splint

Technique of each SM application described
Used commonly accepted index for measuring plaque deposition as an outcome

Method of randomization not described although there was mention of SM “randomly placed” in extraction sites
No information on concealment of allocation
No power calculation
Small sample size
Single centre

Nidhi⁸ 2012

CCT

GFRCR vs. Band and loop (in different quadrants of mouth)

Both SM appliances applied to each patient so that each patient acted as own control to address potential confounding
Procedure for SM application clearly described

Did not describe recruitment
No indication that randomization occurred
Statistical analysis may not be appropriate (used Chi-square instead of McNemar’s test); did not account for correlation
No power calculation
Small sample size
Single centre

Subramaniam⁹ 2008

CCT

GFRCR vs. Band and loop

Both SM appliances applied to each patient so that each patient acted as own control to address potential confounding
Defined inclusion/exclusion criteria
Defined outcomes

No indication that randomization occurred
Did not describe recruitment
No information on concealment of allocation
No power calculation
Small sample size
Single centre

Arikan¹⁰ 2007

Observational

Fixed appliance (band and loop) vs. removable appliance

Used commonly accepted indices for measuring plaque deposition and gingival health as outcomes
Defined most inclusion criteria

Did not describe recruitment
Did not account for confounding
Small sample size; further stratified into smaller groups (verbal vs. written health education; test vs. control teeth); made statistical comparisons even with such small sample sizes
Single centre

Comparisons of different types of SM to each other as well as to No SM:

Rubin¹³ 2012

Observational

Schwarz appliance vs. Lingual holding arch vs. Combination of two appliances vs. Control

Prospective study
Defined inclusion/exclusion criteria
Defined outcomes
Matched comparators based on age (although methods not described)
Provided power calculation
Statistical analysis controlled for some known confounders (i.e., age)
Same investigator checked reliability of measurements made; noted high intraclass correlation coefficients (≥ 0.95)
Large sample size
Multi-centre study

Consecutively recruited patients, which may not provide a representative sample
Potential for residual confounding
Did not describe losses to follow-up
Final time point for outcome measurement and statistical analysis varied among patients (“after treatment with the appliance and before fixed or orthodontic treatment in the permanent dentition” p. 147)

Owais⁶ 2011

Quasi-RCT

LLHA 0.9 mm wire vs. LLHA 1.25 mm wire vs. No SM

Defined inclusion/exclusion criteria
Defined outcomes
Assessed information bias: same examiner reassessed outcome measurements of 10 randomly chosen patients; coefficient of reliability was > 90%
Provided numbers lost to follow-up
Statistical analysis was appropriate; Bonferroni correction used for multiple comparison tests

No information on recruitment
Quasi-random method of treatment assignment (alternation using odd and even numbers)
No information on concealment of allocation
No power calculation
Small sample size
Single centre

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Bookshelf ID: NBK401558

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Dental Space Maintainers for the Management of Premature Loss of Deciduous Molars: A Review of the Clinical Effectiveness, Cost-effectiveness and Guidelines [Internet].

APPENDIX 3CRITICAL APPRAISAL OF INCLUDED PUBLICATIONS

Table A3Strengths and Limitations of Controlled Trials and Observational Studies using Downs and Black⁵

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First Author, Publication Year, Study Design, Comparators	Strengths	Limitations
Space maintainer (SM) vs. none:
Alnahwi¹¹ 2015 Observational SM (mix of band and loop, lower lingual holding arch, transpalatal arch, and Nance holding appliance) vs. No SM	Long follow-up period (up to 48 months) Defined inclusion/exclusion criteria Defined outcomes	Did not describe recruitment Did not account for confounding Grouped different appliances, which may have different treatment effects into one comparator; did not report the proportion of each SM type used Included patients who had SM applied years after primary second molar extraction Small sample size Single centre
Letti¹² 2013 Observational Lingual arch appliance vs. No SM	Used commonly accepted cephalometric analyses to measure outcomes	Did not describe recruitment Did not account for confounding Reported a study error in the outcome measurements; measurements were taken again and no significant differences were found (Student’s t test, p> 0.05) Results did not support conclusions Poor reporting overall Single centre
Comparisons of different types of SM to each other:
Setia⁷ 2014 CCT Band and loop vs. Band and custom loop vs. Ribbond vs. Super splint	Technique of each SM application described Used commonly accepted index for measuring plaque deposition as an outcome	Method of randomization not described although there was mention of SM “randomly placed” in extraction sites No information on concealment of allocation No power calculation Small sample size Single centre
Nidhi⁸ 2012 CCT GFRCR vs. Band and loop (in different quadrants of mouth)	Both SM appliances applied to each patient so that each patient acted as own control to address potential confounding Procedure for SM application clearly described	Did not describe recruitment No indication that randomization occurred Statistical analysis may not be appropriate (used Chi-square instead of McNemar’s test); did not account for correlation No power calculation Small sample size Single centre
Subramaniam⁹ 2008 CCT GFRCR vs. Band and loop	Both SM appliances applied to each patient so that each patient acted as own control to address potential confounding Defined inclusion/exclusion criteria Defined outcomes	No indication that randomization occurred Did not describe recruitment No information on concealment of allocation No power calculation Small sample size Single centre
Arikan¹⁰ 2007 Observational Fixed appliance (band and loop) vs. removable appliance	Used commonly accepted indices for measuring plaque deposition and gingival health as outcomes Defined most inclusion criteria	Did not describe recruitment Did not account for confounding Small sample size; further stratified into smaller groups (verbal vs. written health education; test vs. control teeth); made statistical comparisons even with such small sample sizes Single centre
Comparisons of different types of SM to each other as well as to No SM:
Rubin¹³ 2012 Observational Schwarz appliance vs. Lingual holding arch vs. Combination of two appliances vs. Control	Prospective study Defined inclusion/exclusion criteria Defined outcomes Matched comparators based on age (although methods not described) Provided power calculation Statistical analysis controlled for some known confounders (i.e., age) Same investigator checked reliability of measurements made; noted high intraclass correlation coefficients (≥ 0.95) Large sample size Multi-centre study	Consecutively recruited patients, which may not provide a representative sample Potential for residual confounding Did not describe losses to follow-up Final time point for outcome measurement and statistical analysis varied among patients (“after treatment with the appliance and before fixed or orthodontic treatment in the permanent dentition” p. 147)
Owais⁶ 2011 Quasi-RCT LLHA 0.9 mm wire vs. LLHA 1.25 mm wire vs. No SM	Defined inclusion/exclusion criteria Defined outcomes Assessed information bias: same examiner reassessed outcome measurements of 10 randomly chosen patients; coefficient of reliability was > 90% Provided numbers lost to follow-up Statistical analysis was appropriate; Bonferroni correction used for multiple comparison tests	No information on recruitment Quasi-random method of treatment assignment (alternation using odd and even numbers) No information on concealment of allocation No power calculation Small sample size Single centre