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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04017429
Other study ID # FURC-III-OST
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date June 15, 2027

Study information

Verified date April 2021
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, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade III defects with open flap debridement.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 15, 2027
Est. primary completion date June 15, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Periodontal disease stage III or IV according to 2018 criteria - Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade III with PPD>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs - Competent to give consent Exclusion Criteria: - 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 II according to ASA classification - Previous surgical therapy of included furcation defects - Inhability to comprehend and respond to the quality of life questionnaire - Dental restorations or prosthesis involving the furcation area - Root fractures or suspected fractures/infractions - Caries lesoins in the furcation area - No systemic antibiotic treatment within 3 months prior to intervention

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Open flap debridement with osteoplasty
Treatment of furcation grade III defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to >90 degrees relative to the apico-coronal axis of the tooth.
Open flap debridement without osteoplasty
Treatment of furcation grade III defect with open flap debridement only.

Locations

Country Name City State
Norway Institute of Clinical Dentistry, University of Oslo, Norway 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 Sites with no signs of inflammation Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment 12 months after treatment
Primary Sites with no signs of inflammation Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment 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 Loss of clinical attachment level To assess further loss of clinical attachment level by the use of a periodontal probe 12 months after treatment
Secondary Loss of clinical attachment level To assess further loss of clinical attachment level by the use of a periodontal probe 24 months after treatment
Secondary Number of participants with caries lesions To assess caries lesions in furcation defects following therapy. Caries lesions are assessed clinically with an explorer as caries (Y/N) 24 months after treatment
Secondary Radiographic changes To assess bone loss as measured on standardized radiographs (in mm) 12 months after treatment
Secondary Radiographic changes To assess bone loss as measured on standardized radiographs (in mm) 24 months after treatment
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