Mandibular Furcation II Regeneration (FURC-II-REGEN)

Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade II Defects

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.

Study Overview

• Status: Terminated
• Conditions: Periodontal Diseases; Furcation Defects
• Intervention / Treatment: Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane); Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regenerative therapy w/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 collagen membrane.	Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane); Regenerative therapy with biphasic calcium phosphate + collagen membrane.; Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain); Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.
Active Comparator: Regenerative therapy w/BCP and enamel matrix proteins; 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.	Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane); Regenerative therapy with biphasic calcium phosphate + collagen membrane.; Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain); Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of furcation grade level	Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe	12 months after treatment
Change of furcation grade level	Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe	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
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	24 months after treatment
Changes in CAL	Changes in clinical attachment level will be measured with a probe in mm	12 months after treatment
Changes in CAL	Changes in clinical attachment level will be measured with a probe in mm	24 months after treatment
Changes in PPD	Changes in pocket probing depth will be measured with a probe in mm	12 months after treatment
Changes in PPD	Changes in pocket probing depth will be measured with a probe in mm	24 months after treatment
Radiographic changes	Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs	12 months after treatment
Radiographic changes	Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs	24 months after treatment
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.	Daily for 1 week postoperatively
Caries assessment	Caries in furcation defect assessed with an explorer will be recorded as (Y/N)	12 months
Caries assessment	Caries in furcation defect assessed with an explorer will be recorded as (Y/N)	24 months

Collaborators and Investigators

• Sponsor: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Furcation Defects; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: FURC-II-REGEN

Drug and device information, study documents

• 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