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SANZ et al .
R3.8 | What is the adequate choice of regenerative biomaterials for promoting healing of residual deep pockets associated with a deep intrabony defect? Evidence-based recommendation (3.8) In regenerative therapy, we recommend the use of either barrier membranes or enamel matrix derivative with or without the addition of bone-derived grafts* Supporting literature Nibali et al. (2019) Quality of evidence Twenty RCTs (972 patients)—four studies at low risk of bias—moderate-to-high heterogeneity for superiority of these biomaterials Grade of recommendation Grade A—↑↑ Strength of consensus Consensus (18.1% of the group abstained due to potential CoI) * Clinicians should select a specific biomaterial to be used to promote regeneration at intrabony defects (or Class II furcation involvements) based on satisfaction of all of the following criteria (Proceedings of the, 1996 World Workshop in Periodontics, 1996): (a) availability of solid preclinical research identifying plausible mechanism(s) of action leading to periodontal regeneration; (b) human histological evidence of regeneration in the specific application; and (c) evidence of efficacy in applicable, high-quality randomized controlled clinical trials. While there are biomaterials that satisfy all these criteria, it must be understood that many biomaterials do not meet them in spite of being CE (“Conformité Européene”) marked or Food and Drug Administration (FDA)-approved/cleared.
The combination of membrane with bone-derived graft resulted in higher CAL gain of 1.5 mm (95% CI [0.66; 2.34], equivalent to a 90% improvement) compared with OFD. The comparison between EMD versus GTR resulted in no statistically significant difference in CAL gain. The choice of biomaterial or possible combinations should be based on defect configuration. R3.9 | What is the adequate choice of surgical flap design for the regenerative treatment of residual deep pockets associated with an intrabony defect? Evidence-based recommendation (3.9) We recommend the use of specific flap designs with maximum preservation of interdental soft tissue such as papilla preservation flaps. Under some specific circumstances, we also recommend limiting flap elevation to optimize wound stability and reduce morbidity. Supporting literature Graziani et al. (2012); Nibali et al. (2019) Quality of evidence Ancillary evidence arising from systematic reviews and expert opinion. Grade of recommendation Grade A—↑↑ Strength of consensus Consensus (2.8% of the group abstained due to potential CoI)
Background
Background
Intervention See previous sections.
Intervention See previous sections.
Available evidence The evidence base includes two systematic reviews.
Available evidence The evidence base includes 20 RCTs with 972 patients. The quality of the evidence was considered to be high. Risk of bias Study quality assessment identified four studies at low risk of bias and 15 studies at unclear risk of bias. Consistency Regenerative surgical therapy with a variety of biomaterials resulted in improved clinical outcomes compared with open flap debridement in the majority of studies. No indication of publication bias was ob - served. Moderate to substantial heterogeneity in the size of the ad - junctive effect was observed. Clinical relevance and effect size The mean adjunctive benefit in term of CAL gain was 1.27 mm (95% CI [0.79; 1.74], equivalent to a 77% improvement) for EMD and 1.43 mm (95% CI [0.76; 2.22], equivalent to an 86% improve - ment) for guided tissue regeneration (GTR) compared with OFD.
Risk of bias Study quality assessment identified five studies at low risk of bias and 15 studies at unclear risk of bias.
Consistency No conclusion can be drawn.
Clinical relevance and effect size Papilla preservation flaps have been shown to lead to increased CAL gain and PD reduction as well as reduced post-surgical recession compared with OFD. Balance of benefit and harm No serious adverse event has been reported after application of papilla preservation flaps in regenerative periodontal surgery per - formed by adequately trained clinicians. The added complexity of the surgery requires additional training.
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