Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

Not Applicable

Completed

• Conditions: Periodontal Diseases

• Registration Number: NCT05878353
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-26
• Study Start: 2023-05-30
• Status Verified: 2024-07
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-15
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical attachment level change	12 months	Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Secondary Outcome Measures

Name	Time	Method
Radiographic bone level change	12 months	Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
Probing pocket depth change	12 months	Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Bleeding on probing reduction	12 months	Bleeding on probing will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy