Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: Decontamination of the pocket with local doxycycline; Procedure: Decontamination of the pocket with mechanical instrumentation

• 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

Arm && Interventions

Group	Intervention	Description
Subgingival instrumentation plus local doxycycline	Decontamination of the pocket with local doxycycline	Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration.
Subgingival instrumentation alone	Decontamination of the pocket with mechanical instrumentation	Gentle debridement alone performed 2 weeks prior to periodontal regeneration.

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