Furcation Defects, Periodontal Diseases
Conditions
Brief summary
Teeth with furcation grade II defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade II defects with open flap debridement.
Interventions
Treatment of furcation grade II defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to \>90 degrees relative to the apico-coronal axis of the toot.
Treatment of furcation grade II defect with open flap debridement only.
Sponsors
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Split-mouth design, all subjects receive both interventions
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Periodontal disease stage III or IV according to 2018 criteria * Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD\>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs * Competent to give consent
Exclusion criteria
* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment * Present or past use of bisphosphonate treatment * Pregnant or nursing subjects * Patients classified as \> class II according to ASA classification * Previous surgical therapy of included furcation defects * Inability to comprehend and respond to the quality of life questionnaire * Dental restorations or prosthesis involving the furcation area * Root fractures or suspected fractures/infractions * Caries lesions in the furcation area * No systemic antibiotic treatment within 3 months prior to intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sites with no signs of inflammation | 12 months after treatment | Proportion of sites without inflammation, defined as no BoP or PPD\>4mm following treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patient-reported quality of life (QoL) | Preoperatively compared to 24 months after treatment | To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of The Oral Impacts on Daily Performance (OIDP) instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1) |
| Loss of clinical attachment level | 12 after treatment | To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III) |
| Number of participants with caries lesions | 24 months after treatment | To assess caries lesions in furcation defects following therapy. Caries lesions are assessed clinically with an explorer as caries (Y/N) |
| Radiographic changes | 12 months after treatment | To assess bone loss as measured on standardized radiographs (in mm) |
Countries
Norway
Outcome results
None listed