Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

University of Turin, Italy60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Periodontal Diseases

Interventions

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.

Decontamination of the pocket with mechanical instrumentationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 12 months

Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes