Periodontal Diseases Clinical Trial
— FURC-III-OSTOfficial title:
Treatment of Grade III Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement
Verified date | April 2021 |
Source | University of Oslo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Norway | Institute of Clinical Dentistry, University of Oslo, Norway | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Oslo |
Norway,
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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