Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects (FURC-II-OST)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Periodontal Diseases; Furcation Defects
• Intervention / Treatment: Procedure: Open flap debridement with osteoplasty; Procedure: Open flap debridement without osteoplasty

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0455
    • Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open flap debridement with osteoplasty; In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.	Procedure: Open flap debridement with osteoplasty; 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.; Procedure: Open flap debridement without osteoplasty; Treatment of furcation grade II defect with open flap debridement only.
ACTIVE_COMPARATOR: Open flap debridement without osteoplasty; In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.	Procedure: Open flap debridement with osteoplasty; 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.; Procedure: Open flap debridement without osteoplasty; Treatment of furcation grade II defect with open flap debridement only.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oslo

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2019
• Primary Completion (ANTICIPATED): April 15, 2027
• Study Completion (ANTICIPATED): April 15, 2027

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Furcation Defects
• Other Study ID Numbers: FURC-II-OST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No