Mandibular Furcation III Regeneration (FURC-III-REGEN)

Phase 4TerminatedNCT04059458

University of Oslo5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Furcation Defects Periodontal Diseases

Interventions

Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)DEVICE

Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane.

Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)DRUG

Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins.

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo

Oslo, Norway

Outcomes

Primary Outcomes

Change of furcation grade level

Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe

Time frame: 12 months after treatment

Change of furcation grade level

Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe

Time frame: 24 months after treatment

Secondary Outcomes

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).

Time frame: Preoperatively compared to 24 months after treatment

Changes in patient-reported quality of life (QoL)

Time frame: Preoperatively compared to 12 months after treatment

Changes in defect morphology assessed by CBCT

Data from ClinicalTrials.gov

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