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

Periodontal Pocket Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06438354
• Other study ID #: 64/2022
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: May 2024
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 29, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Pocket

Intervention

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

Locations

Country	Name	City	State
Germany	Implantat Competence Centrum München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinic — View Citation

Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level	Greater amount of CAL gain in the test group A vs. control group B anticipated	9 month post-op
Secondary	Periodontal Probing Depth	Greater reduction in PPD for group A vs. Group B anticipated	9 months post-op
Secondary	Gingival Recession	Similar change in the GR depth anticipated for both groups	9 months post-op
Secondary	Bleeding on Probing	greater reduction in BOP anticipated for group A vs. group B patients.	9 months post-op