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
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
10
current version
GRADE rated
4
No studies
2
Included studies
8
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
Show all 3 versionsDirect 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)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Harms (toxicity and postoperative sensitivity) Follow-up: 2 weeks to 7 years | 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 | 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 | 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 | RR 1.33 [0.84, 2.11] | 6 studies | Ungraded |
Harms: allergic reaction | 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 | RR 1.93 [0.98, 3.80] | 7 studies | Ungraded |
Secondary caries Follow-up >= 3 years · Split-mouth trials | RR 1.30 [0.34, 4.97] | 5 studies | Ungraded |
Restoration failure rate Follow-up >= 3 years · Parallel-group and split-mouth trials combined | RR 1.65 [1.13, 2.40] | 8 studies | Ungraded |
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 |
Harms: injury | 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 |