Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

University of Turin

Status: Completed

Conditions: Periodontal Diseases

Treatments: Procedure: Decontamination of the pocket with local doxycycline; Procedure: Decontamination of the pocket with mechanical instrumentation

Study type: Interventional

Funder types: Other

Identifiers

NCT05878353

DoxyTurin

Details and patient eligibility

About

In this double-blinded randomized clinical trial, patients presenting periodontal intrabony defects requiring regenerative surgery and showing BoP will be included. Experimental sites at T-0 will be randomly treated with gentle debridement and administration of local DOX (test group) or with debridement alone (control group). After 2 weeks (T-1), defects will be treated by means of minimally invasive surgical technique. 14 days after the surgery (T-2) the EHI will be evaluated by a blinded examiner. Patients will be recalled each 2 months up to 12 months (T-3). At T-0, T-1 and T-3 periodontal examination and radiographic analysis will be done.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. diagnosis of Stage III or IV periodontitis (Tonetti et al. 2018);
• 2. FMPS and FMBS < 15% at the time of enrollment;
• 3. etiological periodontal therapy completed at least 3 months prior to screening;
• 4. presence of one natural tooth having a vertical defect with residual PPD ≥ 6 mm and a radiographic intrabony component ≥ 3 mm and BoP + requiring periodontal regenerative surgery.

Exclusion criteria

• 1. age < 18 years;
• 2. smoking habits (> 10 cigarettes/day);
• 3. contraindications for periodontal surgery;
• 4. systemic diseases affecting periodontal healing;
• 5. pregnancy and lactation;
• 6. history of periodontal surgery at the experimental teeth;
• 7. allergies to doxycycline and tetracyclines;
• 8. assumption of antibiotics in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Subgingival instrumentation plus local doxycycline

Experimental group

Description:

Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration.

Treatment:

Procedure: Decontamination of the pocket with local doxycycline

Subgingival instrumentation alone

Active Comparator group

Description:

Gentle debridement alone performed 2 weeks prior to periodontal regeneration.

Treatment:

Procedure: Decontamination of the pocket with mechanical instrumentation