Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects (FURC-II-OST)

• ClinicalTrials.gov Identifier: NCT03917030
• Recruitment Status: Withdrawn
• First Posted: April 16, 2019
• Last Update Posted: April 30, 2021
• Sponsor: University of Oslo
• Information provided by (Responsible Party): Anders Verket, University of Oslo

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Furcation Defects; Periodontal Diseases	Procedure: Open flap debridement with osteoplasty; Procedure: Open flap debridement without osteoplasty	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Split-mouth design, all subjects receive both interventions
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 15, 2019
• Estimated Primary Completion Date: April 15, 2027
• Estimated Study Completion Date: April 15, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Open flap debridement with osteoplasty; In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.	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.; Procedure: Open flap debridement without osteoplasty; Treatment of furcation grade II defect with open flap debridement only.
Active Comparator: Open flap debridement without osteoplasty; In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.	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.; Procedure: Open flap debridement without osteoplasty; Treatment of furcation grade II defect with open flap debridement only.

Outcome Measures

Primary Outcome Measures :

1. Sites with no signs of inflammation [ Time Frame: 12 months after treatment ]
   Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment
2. Sites with no signs of inflammation [ Time Frame: 24 months after treatment ]
   Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment

Secondary Outcome Measures :

1. Changes in patient-reported quality of life (QoL) [ Time Frame: Preoperatively compared to 24 months after treatment ]

   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)

2. Changes in patient-reported quality of life (QoL) [ Time Frame: Preoperatively compared to 12 months after treatment ]

   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)

3. Loss of clinical attachment level [ Time Frame: 12 after treatment ]
   To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III)
4. Loss of clinical attachment level [ Time Frame: 24 months after treatment ]
   To assess further loss of clinical attachment Level vertically and horizontally, and deterioration of furcation grade Level (grade II to III)
5. Number of participants with caries lesions [ Time Frame: 24 months after treatment ]
   To assess caries lesions in furcation defects following therapy. Caries lesions are assessed clinically with an explorer as caries (Y/N)
6. Radiographic changes [ Time Frame: 12 months after treatment ]
   To assess bone loss as measured on standardized radiographs (in mm)
7. Radiographic changes [ Time Frame: 24 months after treatment ]
   To assess bone loss as measured on standardized radiographs (in mm)

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Norway

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

Oslo, Norway, 0455

Sponsors and Collaborators

University of Oslo

More Information

• Responsible Party: Anders Verket, Principal investigator, University of Oslo
• ClinicalTrials.gov Identifier: NCT03917030
• Other Study ID Numbers: FURC-II-OST
• First Posted: April 16, 2019
• Last Update Posted: April 30, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Periodontal Diseases; Furcation Defects; Mouth Diseases; Stomatognathic Diseases