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HERRERA ET AL .
Apart from the evidence included in the SR, three additional RCTs were considered, evaluating the adjunctive effect of an antiseptic (CHX chip), a ‘ postbiotic ’ ( ‘ Lactobacillus Ferment ’ ) and a desiccant gel/liquid (concentrated aqueous mixture of hydroxybenzenesulpho- nic and hydroxymethoxybenzene acids, together with sulphuric acid) as adjunctives to mechanical therapy, compared with mechanical ther- apy plus application of 1% CHX gel (Butera et al., 2022; Lombardo et al., 2019; Sahrmann et al., 2019). Risk of bias For CHX and NaOCl, study quality assessment using the RoB 2 tool identified a low risk of bias for both studies included (Iorio-Siciliano et al., 2020; Menezes et al., 2016). For the other three RCTs, risk of bias was not specifically evaluated, since they were not included in the SR, but their overall quality of evidence was considered as low. Effect sizes and their clinical relevance For CHX, based on one RCT ( n = 37 patients), no additional effect of 0.12% CHX was demonstrated regarding reductions in BOP, PD and PlI. For NaOCl, based on one RCT ( n = 46 patients), no additional effect of 0.95% NaOCl was identified regarding reductions in BOP, PD and PlI. In the case of the individual RCTs, the magnitude of the effect (comparison vs. a negative control or a placebo) could not be determined as the control groups were 1% CHX gel. For the ‘ postbio- tic ’ gel, based on one RCT ( n = 20 patients), no additional effect was demonstrated (Butera et al., 2022). For the desiccant solution, based on one RCT ( n = 23 patients), significant differences between groups were only observed for plaque indices (Lombardo et al., 2019). For the CHX chip, based on one RCT ( n = 32 patients), significant additional ben- efits in BOP were observed in the test group, but the statistically signifi- cant differences observed at baseline precluded a strong conclusion on the adjunctive effect (Sahrmann et al., 2019). The effect of the 1% CHX was heterogeneous, which is beneficial in two studies (Butera et al., 2022; Lombardo et al., 2019), but not in the third (Sahrmann et al., 2019).
PICOS question addressed by an SR
R6.9: Evidence-based recommendation Supporting literature (Dommisch et al., 2023) and (Butera et al., 2022; Lombardo et al., 2019; Sahrmann et al., 2019) and expert opinion Quality of evidence Low Grade of recommendation GradeB — # Strength of consensus Strong consensus (0% of the group abstained due to potential CoI)
Background
Intervention
Professional administration of topical antiseptics/agents (hydrogen peroxide, chlorhexidine, delmopinol hydrochloride, sodium hypochlo- rite, chitosan, acids, ‘ postbiotics ’ ) following non-surgical mechanical/ physical therapy in patients with peri-implant mucositis. ‘ Postbiotics ’ are products of the metabolic activity of the micro-organism, which, by exerting an antioxidant action, lead to a positive effect on the host (Zolkiewicz et al., 2020); in contrast with probiotics, they do not include live microorganisms.
Available evidence
Number and design of included studies Two RCTs were selected by the SR (Dommisch et al., 2023). One of them ( n = 37 patients) assessed the professional administration of 0.12% CHX in 119 implants over the time periods of 1, 3 and 6 months in non-smokers. In the control group, CHX was not pro- fessionally applied. Outcome measures compared PD, BOP and visible plaque index (PlI). Disease resolution, SOP and PROMs were not reported. In both the control and test groups, significant reductions in PD, BOP and visible PlI were observed when com- paring values at baseline with values at the 3- and 6-month follow-up. The inter-group comparison revealed no differences when comparing test and control groups (Menezes et al., 2016). The second one ( n = 46 patients) tested the professional adminis- tration of 0.95% NaOCl in 68 implants over a time period of 1, 3 and 6 months. In the control group, NaOCl was not applied. Out- come measures compared reduction in BOP, PD and a modified PlI. In addition, disease resolution was evaluated. Significant reductions in BOP, PD and the modified PlI for oral implants in both the test and control groups were observed at the 6-month follow-up. The inter-group comparison did not show differences among groups regarding BOP, disease resolution, PD or the modi- fied PlI (Iorio-Siciliano et al., 2020). Changes in SOP as well as PROMs were not reported. Thus, the main finding of the RCTs identified in the SR was that 0.12% CHX or 0.95% NaOCl did not additionally improve clinical outcomes.
Consistency Not applicable.
Balance of benefit and harm In both identified studies, the adjunctive professional administration of 0.12% CHX or 0.95% NaOCl did not cause unintentional side effects that suggest harm to the patient (Iorio-Siciliano et al., 2020; Menezes et al., 2016). Thus, formulations of both CHX and NaOCl may be considered as a professional treatment adjunctive to non- surgical mechanical/physical therapy in the treatment of peri-implant mucositis. Future studies are needed to further investigate the effi- cacy of the given and other concentrations of CHX and NaOCl. For CHX, several adverse effects such as taste alteration, mouth numb- ness, xerostomia, and tooth discoloration have been reported (Poppolo Deus & Ouanounou, 2022). For NaOCl, the occurrence of potential adverse effects is uncertain for various concentrations. Potential adverse side effects must be considered to balance benefits
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