Mandibular Furcation III Regeneration (FURC-III-REGEN)

Phase 4

Terminated

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

• Registration Number: NCT04059458
• Lead Sponsor: University of Oslo

Brief Summary

Teeth with furcation grade III 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Study Start: 2019-10-15
• Status Verified: 2023-11
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regenerative therapy w/BCP and collagen membrane	Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason 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.
Regenerative therapy w/BCP and collagen membrane	Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)	In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
Regenerative therapy w/BCP and enamel matrix proteins	Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason 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.
Regenerative therapy w/BCP and enamel matrix proteins	Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)	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.

Primary Outcome Measures

Name	Time	Method
Change of furcation grade level	24 months after treatment	Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe

Secondary Outcome Measures

Name	Time	Method
Caries assessment	12 months	Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Changes in patient-reported quality of life (QoL)	Preoperatively compared to 12 months after treatment	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	24 months after treatment	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 pocket probing depth	24 months after treatment	Changes in pocket probing depth will be measured with a probe
Changes in PPD	24 months after treatment	Changes in pocket probing depth will be measured with a probe
Radiographic changes	24 months after treatment	Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Pain following surgery	Up to 1 week postoperatively	Pain sensation one week posteoperatively will be recorded on a visual analog scale from 0-10. 0 means no pain sensation, whereas 10 means highest pain imagineable.

Trial Locations

Locations (1)

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo; 🇳🇴 Oslo, Norway