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

University of Witten/Herdecke

Status and phase: Completed; Phase 4

Conditions: Periodontal Pocket

Treatments: Biological: subgingival instrumentation plus Perisolv / hyaDent BG; Procedure: subgingival instrumentation

Study type: Interventional

Funder types: Other

Identifiers

NCT06438354

64/2022

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol.

Treatment:

Biological: subgingival instrumentation plus Perisolv / hyaDent BG

Group B

Placebo Comparator group

Description:

Control arm, patients undergo subgingival instrumentation of residual active site only.

Treatment:

Procedure: subgingival instrumentation