| 37
SANZ et al .
7.5 | Intervention: Management of intrabony defects
tooth survival for a period of 3–20 years show improved tooth re - tention with periodontal regeneration in teeth under regular sup - portive periodontal therapy (28 RCTs summarized in Stavropoulos et al., 2020). Balance of benefit and harm No serious adverse event was reported in any of the studies included in the systematic review. The adverse events associ - ated with regenerative therapy included local adverse events (wound failure) and post-operative morbidity. No specific harm has been reported after regenerative surgery. Potential risk for disease transmission from well-documented human-derived or animal-derived regenerative biomaterials is considered ex - tremely low. Ethical considerations The perception that regenerative treatment of deep intrabony de - fects results in better outcomes than access flap is commonly held in the research and clinical community. Therefore, maximum tissue preservation flap with the application of documented regenerative biomaterials should be the standard of care. This perception is sup - ported by the observation that only 22 of 79 RCTs included in the systematic review used access flap as the control and the majority of the body of evidence compared different regenerative techniques/ biomaterials. Regulatory consideration It is important to emphasise that only few classes of regenerative materials are registered in Europe. In each class, only few materials satisfy the evidence base criteria set forth by these guidelines and the considerations should not be applied to materials that have not been adequately tested. Implementation of the new EU medical de - vice regulations will prove useful. Economic considerations Regenerative surgery is more expensive than access flap surgery but cheaper than tooth replacement necessary as a consequence of tooth loss. In the absence of health-economic data in RCTs included in the review, a pilot study has indicated that the initial increase in cost of regeneration is associated with lower cost of manag - ing recurrence over a 20-year period (Cortellini, Buti, Pini Prato, & Tonetti, 2017). Patient preferences No data are available about patient preference or acceptability. Religious issues may be present for segments of the population since some of the regenerative materials are of porcine or bovine origin. While the use for medical reasons is generally acceptable and has been approved by religious leaders, the sensitivity of individual sub - jects may pose a barrier.
R3.7 | What is the adequate management of residual deep pockets associated with intrabony defects? Evidence-based recommendation (3.7) We recommend treating teeth with residual deep pockets associated with intrabony defects 3 mm or deeper with periodontal regenerative surgery. Supporting literature Nibali et al. (2019) Quality of evidence Twenty-two RCTs (1,182 teeth in 1,000 patients)—four studies at low risk of bias—there is consistency of direction of benefit but high heterogeneity for superiority of regeneration over open flap debridement. Grade of recommendation Grade A—↑↑ Strength of consensus Consensus (10% of the group abstained due to potential CoI)
Background
Intervention See previous sections. An algorithm for clinical decision-making in the treatment by regenerative surgical therapy of intrabony defects and residual pockets is depicted in Figure 1. Available evidence The evidence base includes 22 RCTs with 1,000 patients. The quality of the evidence was rated as 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 resulted in improved clinical out - comes (shallower pockets and higher CAL gain) compared with open flap debridement in the majority of studies. No indication of publi - cation bias was observed. Moderate to substantial heterogeneity in the size of the adjunctive effect was observed. This could be partly explained by the use of specific biomaterials or flap designs. Clinical relevance and effect size The mean adjunctive benefit reported was 1.34 mm (95% CI [0.95; 1.73]) in CAL gain and 1.20 mm (95% CI [0.85; 1.55]) in pocket depth reduction. This represented an 80% (95% CI [60%; 100%]) improve - ment compared to the controls. A mean difference of this magnitude is deemed clinically relevant as it has the potential of decreasing risk of tooth loss. Observational and experimental studies reporting on
Made with FlippingBook Annual report