Back to resultsOsteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects (FURC-II-OST)
Primary Purpose
Furcation Defects, Periodontal Diseases
Status
Withdrawn
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Open flap debridement with osteoplasty
Open flap debridement without osteoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Furcation Defects
Eligibility Criteria
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
Sites / Locations
- Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Open flap debridement with osteoplasty
Open flap debridement without osteoplasty
Arm Description
In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.
In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.
Outcomes
Primary Outcome Measures
Sites with no signs of inflammation
Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment
Sites with no signs of inflammation
Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment
Secondary Outcome Measures
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)
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)
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)
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)
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)
Radiographic changes
To assess bone loss as measured on standardized radiographs (in mm)
Radiographic changes
To assess bone loss as measured on standardized radiographs (in mm)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03917030
Brief Title
Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects
Acronym
FURC-II-OST
Official Title
Treatment of Grade II Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Not feasible to recruit and follow-up subjects due to the pandemic
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
April 15, 2027 (Anticipated)
Study Completion Date
April 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects, Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth design, all subjects receive both interventions
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open flap debridement with osteoplasty
Arm Type
Experimental
Arm Description
In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.
Arm Title
Open flap debridement without osteoplasty
Arm Type
Active Comparator
Arm Description
In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement with osteoplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement without osteoplasty
Intervention Description
Treatment of furcation grade II defect with open flap debridement only.
Primary Outcome Measure Information:
Title
Sites with no signs of inflammation
Description
Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment
Time Frame
12 months after treatment
Title
Sites with no signs of inflammation
Description
Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment
Time Frame
24 months after treatment
Secondary Outcome Measure Information:
Title
Changes in patient-reported quality of life (QoL)
Description
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)
Time Frame
Preoperatively compared to 24 months after treatment
Title
Changes in patient-reported quality of life (QoL)
Description
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)
Time Frame
Preoperatively compared to 12 months after treatment
Title
Loss of clinical attachment level
Description
To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III)
Time Frame
12 after treatment
Title
Loss of clinical attachment level
Description
To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III)
Time Frame
24 months after treatment
Title
Number of participants with caries lesions
Description
To assess caries lesions in furcation defects following therapy. Caries lesions are assessed clinically with an explorer as caries (Y/N)
Time Frame
24 months after treatment
Title
Radiographic changes
Description
To assess bone loss as measured on standardized radiographs (in mm)
Time Frame
12 months after treatment
Title
Radiographic changes
Description
To assess bone loss as measured on standardized radiographs (in mm)
Time Frame
24 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
City
Oslo
ZIP/Postal Code
0455
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects
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