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

Medical University of Bialystok

Status: Active, not recruiting

Conditions: Periodontitis; Periodontal Diseases

Treatments: Drug: SRP+ANB+SURG; Procedure: SRP+SURG

Study type: Interventional

Funder types: Other

Identifiers

NCT07027137

UniBial2

R-I-002/403/2019 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

SRP+SURG

Experimental group

Description:

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

Treatment:

Procedure: SRP+SURG

SRP+ANB+SURG

Experimental group

Description:

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.

Treatment:

Drug: SRP+ANB+SURG