Mandibular Furcation II Regeneration

Periodontal Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04059445
• Other study ID #: FURC-II-REGEN
• Status: Terminated
• Phase: Phase 4
• Start date: October 15, 2019
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Furcation Defects
• Periodontal Diseases

Intervention

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.

Locations

Country	Name	City	State
Norway	Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

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