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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04059458
Other study ID # FURC-III-REGEN
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial 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.


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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
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.
Drug:
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
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.

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 pocket probing depth Changes in pocket probing depth will be measured with a probe 12 months after treatment
Secondary Changes in pocket probing depth Changes in pocket probing depth will be measured with a probe 24 months after treatment
Secondary Changes in PPD Changes in pocket probing depth will be measured with a probe 12 months after treatment
Secondary Changes in PPD Changes in pocket probing depth will be measured with a probe 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 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. Up to 1 week postoperatively
Secondary Caries assessment Caries in furcation defect assessed with an explorer will be recorded as (Y/N) 24 months
Secondary Caries assessment Caries in furcation defect assessed with an explorer will be recorded as (Y/N) 12 months
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