Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects

Periodontal Diseases Clinical Trial

— FURC-II-OST  

Official title:

Treatment of Grade II Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03917030
• Other study ID #: FURC-II-OST
• Status: Withdrawn
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: April 15, 2027

Study information

• Verified date: April 2021
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Teeth with furcation grade II 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 II defects with open flap debridement.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 15, 2027
• Est. primary completion date: April 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 II 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
• Inability 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 lesions in the furcation area
• No systemic antibiotic treatment within 3 months prior to intervention

Related Conditions & MeSH terms

• Furcation Defects
• Periodontal Diseases

Intervention

Procedure:
• Open flap debridement with osteoplasty
Treatment of furcation grade II 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 toot.
• Open flap debridement without osteoplasty
Treatment of furcation grade II defect with open flap debridement only.

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	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 vertically and horizontally, and deterioration of furcation grade Level (grade II to III)	12 after treatment
Secondary	Loss of clinical attachment level	To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III)	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