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

NCT03917030 | Withdrawn

• 1 other identifier: FURC-II-OST
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Furcation Defects; Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• Sites with no signs of inflammation

  Proportion of sites without inflammation, defined as no BoP or PPD\>4mm following treatment

  12 months after treatment

• 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 Outcomes (7)

• Changes in patient-reported quality of life (QoL)

  Preoperatively compared to 24 months after treatment

• Changes in patient-reported quality of life (QoL)

  Preoperatively compared to 12 months after treatment

• Loss of clinical attachment level

  12 after treatment

• Loss of clinical attachment level

  24 months after treatment

• Number of participants with caries lesions

  24 months after treatment

Study Arms (2)

Open flap debridement with osteoplasty

EXPERIMENTAL

In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.

Procedure: Open flap debridement with osteoplasty; Procedure: Open flap debridement without osteoplasty

Open flap debridement without osteoplasty

ACTIVE COMPARATOR

In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.

Procedure: Open flap debridement with osteoplasty; Procedure: Open flap debridement without osteoplasty

Interventions

Open flap debridement with osteoplasty PROCEDURE

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 with osteoplasty; Open flap debridement without osteoplasty

Open flap debridement without osteoplasty PROCEDURE

Treatment of furcation grade II defect with open flap debridement only.

Open flap debridement with osteoplasty; Open flap debridement without osteoplasty

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

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

Oslo, 0455, Norway

Location

MeSH Terms

Conditions

Furcation Defects; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Split-mouth design, all subjects receive both interventions

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: October 15, 2019
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)