Clinical effectiveness of restorative materials for the restoration of carious lesions in pulp treated primary teeth: a systematic review.
Amend S, Boutsiouki C, Bekes K, et al. · European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2022 · PubMed · doi:10.1007/s40368-022-00744-4
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 | Children of any sex and age with carious primary teeth subjected to restorative treatment after vital or non-vital pulp therapy | 364 children (aged 2-10 years); 808 teeth randomised and 695 restorations evaluated across 5 RCTs (n=5 studies); mean follow-up 21.6 months (SD 10) |
| Intervention | Any technique/degree of carious tissue removal combined with a restorative material placed in primary teeth: compomer (C), composite resin (CR), glass-ionomer cement (GIC), resin-modified GIC (RMGIC), metal-reinforced GIC (MRGIC), bio-active materials (BM), amalgam (A), preformed metal/zirconia/composite crowns | Amalgam; composite resin; compomer; RMGIC + composite resin (modified open-sandwich); preformed metal crowns; composite strip crowns with composite/fibre/reverse-metal posts (n=5 studies); no bio-active materials found |
| Comparison | Conventional restorative approach using any other technique/degree of carious tissue removal and/or any other type of restorative material | Head-to-head material or technique comparisons within split-mouth RCTs (n=5 studies) |
| Outcomes | Primary: treatment failure (modified USPHS/FDI criteria) and restoration quality (plus crown-specific success/failure criteria). Secondary: time to failure/re-treatment, discomfort, patient/carer perceptions, and factors influencing effectiveness | Annual failure rate (AFR) and reasons for failure (secondary caries, marginal adaptation, fracture, loss of retention, radiographic pathology); no pooled restoration-quality outcome |
| Study designs | Randomised controlled clinical trials (RCTs) | 5 RCTs, all split-mouth design (published 2006-2020) |
| Timing | Follow-up of at least 12 months | Follow-up 1-3 years (mean 21.6 months, SD 10) |
Search date: December 28, 2020. Databases: MEDLINE/PubMed; EMBASE (via Ovid); Cochrane Library; LILACS; hand search of reference lists of included studies and of published systematic reviews
Questions and results
Preformed metal crowns vs Resin-modified glass-ionomer cement plus composite resin
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Restoration failure 2 years In one RCT, preformed metal crowns had an annual failure rate of 2.5% after 2 years. Source: Table 2; Results, Crowns · same question in other reviews | Annual failure rate (AFR, %) 2.5 | 1 study · 87 participants | Ungraded |
Treatment failure (annual failure rate) 2 years · PMC arm Population: Children with carious primary molars treated by pulpotomy (vital pulp therapy) Preformed metal crowns had a low annual failure rate (2.5%) in primary molars after pulpotomy, but the evidence is of low quality (single high-risk-of-bias split-mouth RCT; not GRADE-rated). Source: Results (Crowns; Quality assessment); Table 2 (Atieh 2008) · same question in other reviews | AFR 2.5 | 1 study · 87 participants | Ungraded |
Treatment failure (annual failure rate) 2 years · RMGIC + composite resin (modified open-sandwich) arm Population: Children with carious primary molars treated by pulpotomy (vital pulp therapy) Modified open-sandwich (RMGIC + composite resin) restorations had an annual failure rate of 3.8% in primary molars after pulpotomy (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Compomer and composite resin; Crowns); Table 2 (Atieh 2008) · same question in other reviews | AFR 3.8 | 1 study · 87 participants | Ungraded |
Compomer (C) vs Composite resin (CR)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Treatment failure (annual failure rate) 2 years · Compomer (C) arm Compomer restorations had an annual failure rate of 8.9% in primary molars after pulpotomy, higher than composite resin in the same trial (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Compomer and composite resin); Table 2 (Cehreli et al. 2006) · same question in other reviews | AFR 8.9 | 1 study · 84 participants | Ungraded |
Restoration failure 2 years Population: Children with carious primary teeth after vital or non-vital pulp therapy In one RCT, composite resin had an annual failure rate of 0% after 2 years. Source: Table 2; Results, Compomer and composite resin · same question in other reviews | Annual failure rate (AFR, %) 0 | 1 study · 84 participants | Ungraded |
Treatment failure (annual failure rate) 2 years · Composite resin (CR) arm Composite resin restorations had an annual failure rate of 0% in primary molars after pulpotomy (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Compomer and composite resin); Table 2 (Cehreli et al. 2006) · same question in other reviews | AFR 0 | 1 study · 84 participants | Ungraded |
Composite strip crowns with composite, fiber, or reverse metal posts vs Alternative post type
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Restoration failure 1 year · Composite post (CP) arm In one RCT, composite strip crowns with composite posts had an annual failure rate of 2.3% after 1 year. Source: Table 2; Results, Crowns · same question in other reviews | Annual failure rate (AFR, %) 2.3 | 1 study · 54 participants | Ungraded |
Treatment failure (annual failure rate) 1 year · Preformed metal crown (PMC) arm Population: Children with carious primary molars treated by pulpotomy (vital pulp therapy) Preformed metal crowns had a low annual failure rate (2.4%) in primary molars after pulpotomy, lower than amalgam in the same trial (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Crowns); Table 2 (Sonmez and Duruturk 2010) · same question in other reviews | AFR 2.4 | 1 study · 83 participants | Ungraded |
Treatment failure (annual failure rate) 1 year · Amalgam (A) arm Population: Children with carious primary molars treated by pulpotomy (vital pulp therapy) Amalgam had the highest annual failure rate (14.3%) among restorations in primary molars after pulpotomy (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Amalgam); Table 2 (Sonmez and Duruturk 2010) · same question in other reviews | AFR 14.3 | 1 study · 83 participants | Ungraded |
Selective caries removal (SCR) + composite resin vs Complete caries removal (CCR) + composite resin
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Treatment failure (annual failure rate) 36 months · Complete caries removal (CCR) arm Complete caries removal with composite resin had an annual failure rate of 6.8% in primary molars (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Compomer and composite resin); Table 2 (Liberman et al. 2020) · same question in other reviews | AFR 6.8 | 1 study · 48 participants | Ungraded |
Restoration failure 2 to 3 years Population: Children with carious primary teeth after vital or non-vital pulp therapy In one RCT, selective caries removal had a 3.44 higher probability of failure than complete caries removal. Source: Results, Compomer and composite resin · same question in other reviews | Relative probability of failure 3.44 | 1 study · 48 participants | Ungraded |
Treatment failure (annual failure rate) 36 months · Selective caries removal (SCR) arm Selective caries removal with composite resin had a higher annual failure rate (17.1%) than complete caries removal in the same trial (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Compomer and composite resin); Table 2 (Liberman et al. 2020) · same question in other reviews | AFR 17.1 | 1 study · 48 participants | Ungraded |
Composite strip crown (CSC) with a post (microhybrid composite resin, Amelogen) vs Post type: composite post (CP) vs fibre post (FP) vs reverse metal post (RMP)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Treatment failure (annual failure rate) 1 year · Composite post (CP) arm Composite strip crowns with composite posts had a low annual failure rate (2.3%) in maxillary primary incisors after pulpectomy (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Crowns); Table 2 (Eshghi et al. 2013) · same question in other reviews | AFR 2.3 | 1 study · 54 participants | Ungraded |
Treatment failure (annual failure rate) 1 year · Fibre post (FP) arm Composite strip crowns with fibre posts had a low annual failure rate (2.2%) in maxillary primary incisors after pulpectomy (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Crowns); Table 2 (Eshghi et al. 2013) · same question in other reviews | AFR 2.2 | 1 study · 54 participants | Ungraded |
Treatment failure (annual failure rate) 1 year · Reverse metal post (RMP) arm Composite strip crowns with reverse metal posts had the lowest annual failure rate (0%) among the three post types in maxillary primary incisors after pulpectomy (single high-risk-of-bias RCT; low quality of evidence; not GRADE-rated). Source: Results (Crowns); Table 2 (Eshghi et al. 2013) · same question in other reviews | AFR 0 | 1 study · 54 participants | Ungraded |
Bio-active restorative materials (containing bio-active compounds) vs Any conventional restorative material
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Treatment failure (planned; no eligible studies) No eligible studies were found evaluating bio-active restorative materials for restoring carious primary teeth after pulp therapy. Source: Results (Characteristics of included studies, final paragraph) · same question in other reviews | No studies were found that reported on the use of restorative materials containing bio-active compounds for the restoration of carious primary teeth after vital or non-vital pulp therapy. | 0 studies | No studies |
AMSTAR 2 appraisal
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | Partial Yes | Partial Yes | yes |
| 3Choice of study designs explained | Yes | Yes | yes |
| 4Comprehensive literature searchcritical | Partial Yes | Partial Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | No | No | yes |
| 8Included studies described in detail | Yes | Yes | yes |
| 9Risk of bias assessed satisfactorilycritical | RCT: Yes · NRSI: N/A | NRSI: N/A · RCT: Yes | no |
| 10Funding of included studies reported | Yes | No | no |
| 11Appropriate meta-analysis methodscritical | RCT: N/A · NRSI: N/A | NRSI: N/A · RCT: N/A | no |
| 12Impact of risk of bias on the pooled results | N/A | N/A | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | N/A | N/A | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Low | Low | yes |
Included primary studies 5
Open as a trial list| Study | Also included by | Outcomes it informs here | Trial PICO | Results |
|---|---|---|---|---|
| Atieh 2008 Stainless steel crown versus modified open‐sandwich restorations for primary molars: a 2‐year randomized clinical trial DOI:10.1111/j.1365-263x.2007.00900.x | 1 other review | Treatment failure (annual failure rate) | not extracted yet | not extracted yet |
| Liberman et al. 2020 (Franzon et al. 2014, 2015) Survival of composite restorations after selective or total caries removal in primary teeth and predictors of failures: A 36-months… DOI:10.1016/j.jdent.2019.103268 | 1 other review | Treatment failure (annual failure rate) | not extracted yet | not extracted yet |
| Cehreli et al. 2006 matched by author and year (probable) | this review only | Treatment failure (annual failure rate) | not extracted yet | not extracted yet |
| Eshghi et al. 2013 matched by author and year (probable) | this review only | Treatment failure (annual failure rate) | not extracted yet | not extracted yet |
| Sonmez and Duruturk 2010 Success rate of calcium hydroxide pulpotomy in primary molars restored with amalgam and stainless steel crowns DOI:10.1038/sj.bdj.2010.446 | this review only | Treatment failure (annual failure rate) | not extracted yet | not extracted yet |
Overlap with other reviews
Reviews that include the same primary studies are not independent evidence. Shared counts match studies by PMID, DOI or NCT, and otherwise by author and year (a probable match).