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

Not Applicable

Withdrawn

• Conditions: Furcation Defects; Periodontal Diseases
• Interventions: Procedure: Open flap debridement with osteoplasty; Procedure: Open flap debridement without osteoplasty

• Registration Number: NCT03917030
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2019-10-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30
• Primary Completion: 2027-04-15
• Study Completion: 2027-04-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open flap debridement with osteoplasty	Open flap debridement with osteoplasty	In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.
Open flap debridement without osteoplasty	Open flap debridement with osteoplasty	In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.
Open flap debridement without osteoplasty	Open flap debridement without osteoplasty	In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.
Open flap debridement with osteoplasty	Open flap debridement without osteoplasty	In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.

Primary Outcome Measures

Name	Time	Method
Sites with no signs of inflammation	24 months after treatment	Proportion of sites without inflammation, defined as no BoP or PPD\>4mm following treatment

Secondary Outcome Measures

Name	Time	Method
Radiographic changes	24 months after treatment	To assess bone loss as measured on standardized radiographs (in mm)
Changes in patient-reported quality of life (QoL)	Preoperatively compared to 12 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	24 months 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)

Trial Locations

Locations (1)

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo; 🇳🇴 Oslo, Norway