Cochrane · intervention · CD005620

Direct composite resin fillings versus amalgam fillings for permanent posterior teeth

Worthington, HV, Khangura, S, Seal, K, et al. · Cochrane Database of Systematic Reviews · 2021 · Cochrane Library

Oral Health Dental caries3 versionsAMSTAR 2: not assessed

Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.

Questions

current version

GRADE rated

No studies

Included studies

as reported

No studies 2 · 20%Ungraded 4 · 40%Very low 1 · 10%Low 3 · 30%Moderate 0 · 0%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

Element	Planned (methods)	Found (results)
Population	Efficacy: people with permanent posterior teeth with dental caries requiring direct restorations suitable for composite resin or amalgam, or both. Safety: people with dental caries treated with direct composite resin or amalgam restorations	871 of 921 analysed participants from two parallel-group trials (children aged 6-12 years); six split-mouth trials reported 2230 restorations (participant numbers/ages unclear)
Intervention	Direct dental restorations made from composite resin	Composite resin restoration (n=1645 parallel; split-mouth restorations also included)
Comparison	Direct dental restorations made from amalgam	Amalgam restoration (n=1365 parallel; split-mouth restorations also included)
Outcomes	Primary: restoration failure (or survival); harms (toxicity, sensitivity, allergic reaction, injury). Secondary: reason for failure (USPHS: colour match, marginal adaptation, anatomical form, secondary caries) and tooth fracture	Failure rate (n=3010 parallel); Secondary caries (n=3010 parallel); Fracture of restorations (n=3010 parallel); Harms (toxicity and postoperative sensitivity; 3 studies; narrative)
Study designs	Efficacy: RCTs (parallel-group or split-mouth), follow-up 3 years or more. Safety: RCTs and non-randomised studies directly comparing composite resin and amalgam (from 2007)	Two parallel-group RCTs; six split-mouth RCTs
Timing	Efficacy follow-up 3 years or more	Follow-up 3 to 7 years (harms 2 weeks to 7 years)

Search date: 2021-02. Databases: Cochrane Oral Health Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; LILACS BIREME Virtual Health Library; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform

Questions and results

Current version only

Direct composite resin restoration vs Amalgam restoration

Population: People with permanent or adult posterior teeth requiring restoration (parallel-group trials involved children aged 6 to 12 years)

CD005620.PUB3 (current) · 10 questions

Outcome	Effect	Evidence	Status / GRADE
Harms (toxicity and postoperative sensitivity) Follow-up: 2 weeks to 7 years same question in other reviews	SoF (Harms, follow-up 2 weeks to 7 years): See comments; 3 studies; certainty very low (⊕⊝⊝⊝). Comments: data were reported for physical development, neurological and psychological effects, neurobehavioural and…	3 studies	Very low Downgraded: risk of bias, imprecision, inconsistency
Restoration failure rate Follow-up: 5 to 7 years same question in other reviews	RR 1.89 [1.52, 2.35] 67 [39, 101] more per 1000	2 studies · 921 participants	Low Downgraded: risk of bias, inconsistency
Secondary caries Follow-up: 5 to 7 years same question in other reviews	RR 2.14 [1.67, 2.74] 65 [38, 99] more per 1000	2 studies · 921 participants	Low Downgraded: risk of bias, inconsistency
Restoration failure rate Follow-up >= 3 years · Split-mouth trials same question in other reviews	RR 1.33 [0.84, 2.11]	6 studies	Ungraded
Harms: allergic reaction same question in other reviews	We did not find any eligible studies that evaluated allergic reaction or injury (no studies reported on outcomes of relevance to allergic reaction).	0 studies	No studies
Secondary caries Follow-up >= 3 years · Parallel-group and split-mouth trials combined same question in other reviews	RR 1.93 [0.98, 3.80]	7 studies	Ungraded
Secondary caries Follow-up >= 3 years · Split-mouth trials same question in other reviews	RR 1.30 [0.34, 4.97]	5 studies	Ungraded
Restoration failure rate Follow-up >= 3 years · Parallel-group and split-mouth trials combined same question in other reviews	RR 1.65 [1.13, 2.40]	8 studies	Ungraded
Fracture of restorations Follow-up: 5 to 7 years same question in other reviews	RR 0.87 [0.46, 1.64] -2 [-8, 9] per 1000 (fewer)	2 studies · 921 participants	Low Downgraded: risk of bias, imprecision
Harms: injury same question in other reviews	We did not find any eligible studies that evaluated allergic reaction or injury (no studies reported on outcomes of relevance to injury).	0 studies	No studies

Direct composite resin restoration vs Amalgam restoration

Population: People with permanent or adult posterior teeth requiring restoration (parallel-group trials involved children aged 6 to 12 years)

CD005620.PUB2 · 9 questions

Outcome	Effect	Evidence	Status / GRADE
Secondary caries Follow-up: 5 to 7 years	RR 2.14 [1.67, 2.74] 65 [38, 99] more per 1000	2 studies · 921 participants	Low Downgraded: risk of bias, inconsistency
Fracture of restorations Follow-up: 5 to 7 years	RR 0.87 [0.46, 1.64] -2 [-8, 9] per 1000 (fewer)	2 studies · 921 participants	Low Downgraded: risk of bias, imprecision
Restoration failure rate Follow-up >= 3 years · Split-mouth trials	RR 1.33 [0.84, 2.11]	5 studies	Ungraded
Adverse events (neurobehavioural, renal, psychosocial function, physical development) Up to 7 years	SoF (Adverse events): See comments. Data were reported for neurobehavioral assessment, kidney function, psychosocial function, physical development. None of these outcomes were reported in more than 1 study. Evidence…	2 studies	Ungraded
Restoration failure rate Follow-up >= 3 years · Parallel-group and split-mouth trials combined	RR 1.62 [1.13, 2.4]	7 studies	Ungraded
Secondary caries Follow-up >= 3 years · Split-mouth trials	RR 1.3 [0.34, 4.97]	4 studies	Ungraded
Secondary caries Follow-up >= 3 years · Parallel-group and split-mouth trials combined	RR 1.93 [0.98, 3.80]	6 studies	Ungraded
Restoration failure rate Follow-up: 5 to 7 years	RR 1.89 [1.52, 2.35] 67 [39, 101] more per 1000	2 studies · 921 participants	Low Downgraded: risk of bias, inconsistency
Cost (resource use: treatment time plus material costs) Follow-up >= 3 years	We found insufficient outcome data on the cost of restorations, therefore this outcome was not covered in the review.	0 studies	No studies

Direct resin composite restoration vs Amalgam (dental amalgam) restoration

Population: Adults and adolescents with permanent posterior teeth suitable (with tooth decay) for resin composite or amalgam restorations, or both; Class I and II cavities (excluding Class V)

CD005620 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR Follow-up >= 3 years	no estimate extracted	0 studies	No studies