Clinical trial NCT04059458: Mandibular Furcation III Regeneration (FURC-III-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 III Defects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Furcation Defects
Periodontal Diseases
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of furcation grade level
timeFrame: 12 months after treatment
measure: Change of furcation grade level
timeFrame: 24 months after treatment
Secondary outcomes:
measure: Changes in patient-reported quality of life (QoL)
timeFrame: Preoperatively compared to 24 months after treatment
measure: Changes in patient-reported quality of life (QoL)
timeFrame: Preoperatively compared to 12 months after treatment
measure: Changes in defect morphology assessed by CBCT
timeFrame: 24 months after treatment
measure: Changes in pocket probing depth
timeFrame: 12 months after treatment
measure: Changes in pocket probing depth
timeFrame: 24 months after treatment
measure: Changes in PPD
timeFrame: 12 months after treatment
measure: Changes in PPD
timeFrame: 24 months after treatment
measure: Radiographic changes
timeFrame: 12 months after treatment
measure: Radiographic changes
timeFrame: 24 months after treatment
measure: Pain following surgery
timeFrame: Up to 1 week postoperatively
measure: Caries assessment
timeFrame: 24 months
measure: Caries assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Study officials:
References: