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

N/AActive Not RecruitingNCT07027137

Medical University of Bialystok40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periodontitis Periodontal Diseases

Interventions

SRP+ANB+SURGDRUG

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

SRP+SURGPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Integrated Dentistry, Medical University of Białystok

Bialystok, Podlaskie Voivodeship, Poland

Outcomes

Primary Outcomes

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)

Time frame: up to 12 months after treatment procedure

Secondary Outcomes

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

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)

Time frame: up to 12 months after treatment procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.