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Active, Not Recruiting

NCT Number: NCT07027137

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Integrated Dentistry, Medical University of Białystok

Bialystok, Podlaskie Voivodeship, 15-089, Poland

About this study

Forty generally healthy adults diagnosed with stage III periodontitis were randomly divided into two groups. In the test group, SRP was 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, on the day of the surgical treatment, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). Clinical examination was performed before and 6 and 12 months after treatment. For radiological measurements RVG was performed. For inflammation mediators levels determination in GCF samples ELISA method will be used. For microbiological assessments Real Time PCR method will be used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-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;

Exclusion criteria

  • 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

Treatment and study plan

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+SURG

Procedure

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

Primary outcomes

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

    Time frame: up to 12 months after treatment procedure

    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)

Secondary outcomes

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

    Time frame: up to 12 months after treatment procedure

    RIDW- (radiological intrabony defect width)- measured from bone crest to the root surface (mm) RIDD - (radiologial intrabony defect depth) - measured from bone crest to the bottom of the defect (mm)

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Acronym: ANBperio

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

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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