search
Back to results

Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade III Furcation Defects (FURC-III-OST) (FURC-III-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Withdrawn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
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 III 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
  • Inhability 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 lesoins in the furcation area
  • No systemic antibiotic treatment within 3 months prior to intervention

Sites / Locations

  • Institute of Clinical Dentistry, University of Oslo, Norway

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 by the use of a periodontal probe
Loss of clinical attachment level
To assess further loss of clinical attachment level by the use of a periodontal probe
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

First Posted
July 8, 2019
Last Updated
April 27, 2021
Sponsor
University of Oslo
search

1. Study Identification

Unique Protocol Identification Number
NCT04017429
Brief Title
Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade III Furcation Defects (FURC-III-OST)
Acronym
FURC-III-OST
Official Title
Treatment of Grade III 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
June 15, 2027 (Anticipated)
Study Completion Date
June 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 III 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 III 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
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 III 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 tooth.
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement without osteoplasty
Intervention Description
Treatment of furcation grade III 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 by the use of a periodontal probe
Time Frame
12 months after treatment
Title
Loss of clinical attachment level
Description
To assess further loss of clinical attachment level by the use of a periodontal probe
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 III 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 Inhability 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 lesoins in the furcation area No systemic antibiotic treatment within 3 months prior to intervention
Facility Information:
Facility Name
Institute of Clinical Dentistry, University of Oslo, Norway
City
Oslo
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 III Furcation Defects (FURC-III-OST)

We'll reach out to this number within 24 hrs