Periodontal Diseases
Conditions
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.
Interventions
PROCEDUREDecontamination of the pocket with local doxycycline
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.
PROCEDUREDecontamination of the pocket with mechanical instrumentation
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.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Outcome results
None listed