The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.

NCT07027137 | Active Not Recruiting

• 2 other identifiers: UniBial2R-I-002/403/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Assessmnet of the influence of local antibiotic therapy on the clinical, radiological, microbiological parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) following periodontal regeneration procedures in patients with periodontitis.

Conditions

Periodontitis; Periodontal Diseases

Keywords

periodontitis; periodontal regeneration; local antibiotics

Outcome Measures

Primary Outcomes (1)

• Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures.

  PD (Pocket Depth) reduction- measured from the gingival margin to the bottom of the sulcus (mm) CAL (Clinical Attachment Level) gain- measured from the cemento-enamel junction to the bottom of the sulcus (mm)

  up to 12 months after treatment procedure

Secondary Outcomes (1)

• Assessment of the influence of local antibiotic therapy on the radiological outcomes following periodontal regeneration procedures.

  up to 12 months after treatment procedure

Study Arms (2)

SRP+SURG

EXPERIMENTAL

In the control group (20 subjects) SRP was performed alone. After two weeks regeneration procedure was performed.

Procedure: SRP+SURG

SRP+ANB+SURG

EXPERIMENTAL

The test group consisted of 20 people participants who underwent the SRP procedure with local antibiotic application into the pocket was performed. After two weeks regeneration procedure was performed.

Drug: SRP+ANB+SURG

Interventions

SRP+ANB+SURG DRUG

SRP (scaling and root planing) with ANB (local antibiotic application- 10%doxycycline) and SURG (regeneration procedure according to MIST/M-MIST)

SRP+ANB+SURG

SRP+SURG PROCEDURE

SRP (scaling and root planing) and SURG (regeneration procedure according to MIST/M-MIST)

SRP+SURG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of an intrabony defect, with a pocket depth (PD) ≥ 6 mm and a radiological defect depth of ≥3 mm and width of ≥2 mm;

You may not qualify if:

• periodontal treatment within 3 months prior to the study;
• antibiotic therapy within 3 months prior to the study;
• smoking; presence of systemic diseases affecting periodontal healing, i.e.: immunosuppressive diseases, diabetes, osteoporosis, AIDS, hypertension treated with calcium channel blockers;
• use of steroids or other immunosuppressive drugs;
• pregnant and breastfeeding women

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Department of Integrated Dentistry, Medical University of Białystok

Bialystok, Podlaskie Voivodeship, 15-089, Poland

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study group consisted of 20 people participants who underwent the SRP procedure (scaling and root planing) performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after SRP, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). All surgical interventions were performed under local anesthesia (Septanest, Septodont, Paris, France). After intrabony defect exposure the granulation tissue was excised using the hand instruments (Gracey currettes (SMS), Hu-Friedy, Chicago, IL, USA), the root surface was conditioned with 24% EDTA (PrefGel®, Straumann, Switzerland) and defect was filled with enamel matrix derivative (Emdogain®, Straumann, Switzerland). Once procedure was completed, the mucoperiosteal flap was repositioned and stabilized with sutures.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: August 1, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)