Back to resultsMandibular Furcation II Regeneration (FURC-II-REGEN)
Primary Purpose
Furcation Defects, Periodontal Diseases
Status
Recruiting
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Sponsored by
About this trial
This is an interventional treatment trial for Furcation Defects
Eligibility Criteria
Inclusion Criteria:
- Subject must be ≥ 20 years
- Subject must have periodontal disease as determined by the World Workshop 2017 criteria
- Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD >4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
- Competent to give consent
Exclusion Criteria:
The following must not be present at the time of enrolment;
- 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 2 according to the ASA (American Society of Anesthesiologists) physical status 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 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 OsloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Regenerative therapy w/BCP and collagen membrane
Regenerative therapy w/BCP and enamel matrix proteins
Arm Description
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.
Outcomes
Primary Outcome Measures
Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
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).
Changes in defect morphology assessed by CBCT
Cone beam computed tomography will be acquired at baseline, 2 weeks postoperatively and 24 months postoperatively. This outcome measures quantitative morphologic changes in the furcation defects at 24 months
Changes in CAL
Changes in clinical attachment level will be measured with a probe in mm
Changes in CAL
Changes in clinical attachment level will be measured with a probe in mm
Changes in PPD
Changes in pocket probing depth will be measured with a probe in mm
Changes in PPD
Changes in pocket probing depth will be measured with a probe in mm
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Pain following surgery
Pain sensation for one week posteoperatively will be recorded on a visual analog scale scale from 0-10. 0 is equivalent to no pain, whereas 10 is the highest pain imagineable.
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04059445
Brief Title
Mandibular Furcation II Regeneration
Acronym
FURC-II-REGEN
Official Title
Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade II Defects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Teeth with furcation grade II defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.
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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regenerative therapy w/BCP and collagen membrane
Arm Type
Experimental
Arm Description
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
Arm Title
Regenerative therapy w/BCP and enamel matrix proteins
Arm Type
Active Comparator
Arm Description
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.
Intervention Type
Device
Intervention Name(s)
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
Intervention Description
Regenerative therapy with biphasic calcium phosphate + collagen membrane.
Intervention Type
Drug
Intervention Name(s)
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Intervention Description
Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.
Primary Outcome Measure Information:
Title
Change of furcation grade level
Description
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Time Frame
12 months after treatment
Title
Change of furcation grade level
Description
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
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
Changes in defect morphology assessed by CBCT
Description
Cone beam computed tomography will be acquired at baseline, 2 weeks postoperatively and 24 months postoperatively. This outcome measures quantitative morphologic changes in the furcation defects at 24 months
Time Frame
24 months after treatment
Title
Changes in CAL
Description
Changes in clinical attachment level will be measured with a probe in mm
Time Frame
12 months after treatment
Title
Changes in CAL
Description
Changes in clinical attachment level will be measured with a probe in mm
Time Frame
24 months after treatment
Title
Changes in PPD
Description
Changes in pocket probing depth will be measured with a probe in mm
Time Frame
12 months after treatment
Title
Changes in PPD
Description
Changes in pocket probing depth will be measured with a probe in mm
Time Frame
24 months after treatment
Title
Radiographic changes
Description
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Time Frame
12 months after treatment
Title
Radiographic changes
Description
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Time Frame
24 months after treatment
Title
Pain following surgery
Description
Pain sensation for one week posteoperatively will be recorded on a visual analog scale scale from 0-10. 0 is equivalent to no pain, whereas 10 is the highest pain imagineable.
Time Frame
Daily for 1 week postoperatively
Title
Caries assessment
Description
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Time Frame
12 months
Title
Caries assessment
Description
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject must be ≥ 20 years
Subject must have periodontal disease as determined by the World Workshop 2017 criteria
Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD >4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
Competent to give consent
Exclusion Criteria:
The following must not be present at the time of enrolment;
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 2 according to the ASA (American Society of Anesthesiologists) physical status 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 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Verket, PhD
Phone
+47 93667661
Email
anderver@odont.uio.no
First Name & Middle Initial & Last Name & Degree
Odd Koldsland, PhD
Phone
+47 93098618
Email
oddcko@odont.uio.no
12. IPD Sharing Statement
Learn more about this trial
Mandibular Furcation II Regeneration
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