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

NCT06438354 | Completed Phase 4

• 1 other identifier: 64/2022
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level

  Greater amount of CAL gain in the test group A vs. control group B anticipated

  9 month post-op

Secondary Outcomes (3)

• Periodontal Probing Depth

  9 months post-op

• Gingival Recession

  9 months post-op

• Bleeding on Probing

  9 months post-op

Study Arms (2)

Group A

EXPERIMENTAL

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

Biological: subgingival instrumentation plus Perisolv / hyaDent BG

Group B

PLACEBO COMPARATOR

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

Procedure: subgingival instrumentation

Interventions

subgingival instrumentation plus Perisolv / hyaDent BG BIOLOGICAL

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.

Group A

subgingival instrumentation PROCEDURE

Group B: sites requiring re-treatment are subjected to subgingival scaling

Group B

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

Implantat Competence Centrum München

Munich, 80333, Germany

Location

Related Publications (3)

• 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 clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.

  PMID: 37740107 RESULT

• 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-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7.

  PMID: 38676852 RESULT

• Benyei L, Friedmann A, Ostermann T, Diehl D. Non-surgical treatment of residual periodontal pockets using sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid-a 9-month pilot randomized controlled clinical trial. Clin Oral Investig. 2024 Sep 5;28(9):513. doi: 10.1007/s00784-024-05906-w.

  PMID: 39235513 DERIVED

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: August 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: February 29, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)