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

NCT ID: NCT06438354

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-02-29

Brief Summary

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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

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Conditions

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Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

subgingival instrumentation plus Perisolv / hyaDent BG

Intervention Type 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 B

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

Group Type PLACEBO_COMPARATOR

subgingival instrumentation

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type BIOLOGICAL

subgingival instrumentation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Witten/Herdecke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Implantat Competence Centrum München

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 37740107 (View on PubMed)

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.

Reference Type RESULT
PMID: 38676852 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39235513 (View on PubMed)

Other Identifiers

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64/2022

Identifier Type: -

Identifier Source: org_study_id