Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: Decontamination of the pocket with local doxycycline
* Procedure: Decontamination of the pocket with mechanical instrumentation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subgingival instrumentation plus local doxycycline<br>Gentle debridement plus local doxycycline administered 2 weeks prior to periodontal regeneration. | Procedure: Decontamination of the pocket with local doxycycline<br>* Gentle debridement will be performed under local anesthesia (mepivacain 2% 1:1000) for a time of 5 minutes by mean of ultrasonic devices by the same experienced clinician. Great attention will be made to avoid marginal and interproximal soft tissue damage. Local doxycycline was administered according to the manufacturer's instruction. Briefly, the plastic needle of the syringe will be inserted into the sulcus and the product will be progressively released in the periodontal pocket up to the gingival margin. The syringe will be then removed and a cotton pellet used to compact the gel into the sulcus. Patients will be then instructed not to floss or use interdental brushes in that area for the following 10 days.<br>|
| Active Comparator: Subgingival instrumentation alone<br>Gentle debridement alone performed 2 weeks prior to periodontal regeneration. | Procedure: Decontamination of the pocket with mechanical instrumentation<br>* Gentle debridement will be performed under local anesthesia (mepivacain 2% 1:1000) for a time of 5 minutes by mean of ultrasonic devices by the same experienced clinician. Great attention will be made to avoid marginal and interproximal soft tissue damage.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone level change | 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) | 12 months | 
| Probing pocket depth change | Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA) | 12 months | 
| Bleeding on probing reduction | Bleeding on probing will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA) | 12 months |