Objectives: The objective of this study was to evaluate the benefit of repeated subgingival cleaning with a low-concentrated hypochlorite/amino acid gel in subjects in maintenance care with residual pockets ≥ 5 mm.
Material and methods: Examiner masked, randomized two-arm parallel design. Thirty-two adult periodontal patients in maintenance phase, > 3 months after periodontal therapy, with at least one residual periodontal pocket ≥ 5 mm, were randomly assigned to treatment by subgingival ultrasonic debridement with the gel or ultrasonic debridement only. At months 0, 4, and 8, all sites presenting with a probing depth (PD) ≥ 5 mm were treated. Six sites were monitored on each tooth. The primary end point was the presence or absence of PD ≥ 5 mm after 12 months. Secondary clinical outcomes were oral tissue safety; patient acceptance; changes in PD; bleeding on probing; recession after 4, 8, and 12 months; and the presence or absence of six target microorganisms in treated pockets at baseline, after 7 days and 4 months.
Results: A total of 365 sites in 32 patients with PD ≥ 5 mm were treated at baseline. At the final evaluation at month 12, 47% of these sites in the test and 49% in the control group were still in this PD category. The difference between baseline and month 12 was significant in both groups (p < 0.01), whereas the difference between groups was not. Repeated short ultrasonic instrumentation with adjunctive administration of the test product resulted in a clinical attachment level (CAL) gain of 1.02 mm (p < 0.01) and led to - 0.97 mm of pocket reduction (p < 0.01) without inducing further recession. However, repeated short ultrasonic debridement without the gel led to a similar clinical outcome (p < 0.01). No adverse events were recorded.
Conclusions: Short ultrasonic instrumentation of residual pockets with PD ≥ 5 mm during maintenance visits resulted in a clinically relevant CAL gain and PD reduction in the order of 1 mm in 1 year, without inducing further recession.
Clinical relevance: This study corroborates the benefit of regular maintenance care after periodontal therapy, including short debridement of the residual pockets.
Keywords: Clinical trial; Hypochlorite/amino acid gel; Maintenance; Subgingival plaque removal.