A thermosensitive gel with an active hyaluronic acid ingredient that contains an octenidine preservation system as an adjunct to scaling and root planning: a randomized prospective clinical study

Abstract

Objectives: To evaluate the adjunctive effect of a thermosensitive gel formulation that contains 0.8% oligo hyaluronic acid (HA) combined with a preservation system of octenidine HCl 0.625% and phenoxyethanol to scaling and root planing (SRP) as compared with SRP alone in the treatment of residual pockets of patients with stage 3 periodontitis.

Materials and methods: Thirty-four patients (21 males and 13 females) aged 29-78 years (51.3 ± 13.1) with stage 3 periodontitis were recruited to participate in the present split-mouth study. None of the patients has been previously treated for periodontitis. Plaque index (PI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were evaluated at baseline and at 3 and 6 months post treatment. Full-mouth SRP was performed in all residual pockets ≥ 5 mm. Treatment was performed by means of ultrasonic and hand instruments and lasted 45-60 min. The gel was applied subgingivally in the test sites immediately after SRP (baseline) and 1 month later. The paired t-test for two means was applied to test the statistical significance of the change from baseline within each arm and determine the difference between groups. The level of significance was set at 0.05 for all tests.

Results: Mean PD reductions between baseline and 3 and 6 months were 1.98 mm and 2.79 mm for the test and 1.22 mm and 1.50 mm for the control group, respectively. Comparisons between the test and control groups revealed that SRP + gel yielded statistically significantly higher PD reductions compared to SRP alone (p < 0.0001). Compared to baseline, CAL and BOP values improved statistically significantly in both groups, although the test group presented statistically significantly higher CAL gains and BOP reductions than the control group (P < 0.0001).

Conclusion: In residual pockets of stage 3 periodontitis patients, the local application of a thermosensitive gel with an active HA ingredient and a preservation system of octenidine HCl 0.625% in conjunction with SRP may additionally improve the clinical outcomes obtained with SRP alone.

Clinical relevance: A novel HA and octenidine containing thermosensitive gel effectively improved the clinical parameters in stage 3 periodontitis patients over a 6-month period.

Keywords: Dental biofilm; Hyaluronic acid; Octenidine HCl; Stage 3 periodontitis; Thermosensitive gel.