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OpenTrials
Completed

NCT Number: NCT06438354

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

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.

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Key information

Conditions

Periodontal Pocket Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Implantat Competence Centrum München

Munich, 80333, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Subgingival Instrumentation

Procedure

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

Primary outcomes

  1. Clinical Attachment Level

    Time frame: 9 month post-op

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

Secondary outcomes

  1. Periodontal Probing Depth

    Time frame: 9 months post-op

    Greater reduction in PPD for group A vs. Group B anticipated

  2. Gingival Recession

    Time frame: 9 months post-op

    Similar change in the GR depth anticipated for both groups

  3. Bleeding on Probing

    Time frame: 9 months post-op

    greater reduction in BOP anticipated for group A vs. group B patients.

Sponsors and collaborators

Lead sponsor

University of Witten/Herdecke

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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