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

Phase 4

Completed

• Conditions: Periodontal Pocket
• Interventions: Procedure: subgingival instrumentation; Biological: subgingival instrumentation plus Perisolv / hyaDent BG

• Registration Number: NCT06438354
• Lead Sponsor: University of Witten/Herdecke

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2023-10-30
• Study Completion: 2024-02-29
• Status Verified: 2024-05
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• systemically healthy individuals, smokers and non-smokers, HbA1c <7.5%, compliant and adhering to systematic periodontal treatment protocol incl. SPT visits, patients willing to complete a 9-month post-op observation period

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Exclusion Criteria

• rheumatoid arthritis, HbA1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	subgingival instrumentation	Control arm, patients undergo subgingival instrumentation of residual active site only.
Group A	subgingival instrumentation plus Perisolv / hyaDent BG	Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol.

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	9 month post-op	Greater amount of CAL gain in the test group A vs. control group B anticipated

Secondary Outcome Measures

Name	Time	Method
Periodontal Probing Depth	9 months post-op	Greater reduction in PPD for group A vs. Group B anticipated
Gingival Recession	9 months post-op	Similar change in the GR depth anticipated for both groups
Bleeding on Probing	9 months post-op	greater reduction in BOP anticipated for group A vs. group B patients.

Trial Locations

Locations (1)

Implantat Competence Centrum München; 🇩🇪 Munich, Germany