NCT06438354

Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT.

Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Witten/Herdecke · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation.

Conditions

• Periodontal Pocket

Interventions

Type	Name	Description
BIOLOGICAL	subgingival instrumentation plus Perisolv / hyaDent BG	Group A: Perisolv is applied prior to subgingival instrumentation for disinfecting purpose, hyaDent BG seals the site for accelerated blood clot stabilisation and support of cell proliferation.
PROCEDURE	subgingival instrumentation	Group B: sites requiring re-treatment are subjected to subgingival scaling

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-10-30
• Completion: 2024-02-29
• First posted: 2024-05-31
• Last updated: 2024-05-31

Locations

1 site across 1 country: Germany