Periodontal Pocket, Periodontitis
Conditions
Keywords
non-surgical periodontal therapy, re-instrumentation
Brief summary
There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets. The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated
Interventions
PROCEDURENon surgical re-instrumentation
The sites showing remaining pockets (PD\>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.
PROCEDUREFlap surgery
All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).
Sponsors
University of Florence
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18aa * Patients with periodontal disease * Less than 20 cigarettes/day * No systemic antibiotic therapy in the last 3 months * At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray * Full-mouth plaque score and full-mouth bleeding score \<15% at baseline (re-evaluation) measured at six sites per tooth * No previous periodontal surgery at the experimental tooth
Exclusion criteria
* Connective tissue diseases * Diabetes * Pregnancy or lactating * Furcation involvement * Crowned tooth * Severe tooth mobility (class III) * Radiographical horizontal bone resorption exceeding the 50% of the root
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD change | 3 months after the procedure | change in periodontal probing depth (in mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAL change | 3 months after the procedure | change in clinical attachment level (in mm) |
Countries
Italy
Outcome results
None listed