Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Grade II Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement

Conditions
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Furcation Defects, Periodontal Diseases

Intervention / Treatment
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* Procedure: Open flap debridement with osteoplasty
* Procedure: Open flap debridement without osteoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 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
Interventional Model Description: Split-mouth design, all subjects receive both interventions
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open flap debridement with osteoplasty<br>In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area. | Procedure: Open flap debridement with osteoplasty<br>* 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.<br>Procedure: Open flap debridement without osteoplasty<br>* Treatment of furcation grade II defect with open flap debridement only.<br>|
| Active Comparator: Open flap debridement without osteoplasty<br>In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed. | Procedure: Open flap debridement with osteoplasty<br>* 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.<br>Procedure: Open flap debridement without osteoplasty<br>* Treatment of furcation grade II defect with open flap debridement only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sites with no signs of inflammation | Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment | 12 months after treatment | 
| Sites with no signs of inflammation | Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment | 24 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patient-reported quality of life (QoL) | 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) | Preoperatively compared to 24 months after treatment | 
| Changes in patient-reported quality of life (QoL) | 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) | Preoperatively compared to 12 months after treatment | 
| Loss of clinical attachment level | To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III) | 12 after treatment | 
| Loss of clinical attachment level | To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III) | 24 months after treatment | 
| Number of participants with caries lesions | To assess caries lesions in furcation defects following therapy. Caries lesions are assessed clinically with an explorer as caries (Y/N) | 24 months after treatment | 
| Radiographic changes | To assess bone loss as measured on standardized radiographs (in mm) | 12 months after treatment | 
| Radiographic changes | To assess bone loss as measured on standardized radiographs (in mm) | 24 months after treatment |