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

University of Oslo

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Furcation Defects Periodontal Diseases

Interventions

Open flap debridement with osteoplastyPROCEDURE

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 osteoplastyPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute of Clinical Dentistry, University of Oslo, Norway

Oslo, Norway

Outcomes

Primary Outcomes

Sites with no signs of inflammation

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

Time frame: 12 months after treatment

Sites with no signs of inflammation

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

Time frame: 24 months after treatment

Secondary Outcomes

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)

Time frame: Preoperatively compared to 24 months after treatment

Changes in patient-reported quality of life (QoL)

Time frame: Preoperatively compared to 12 months after treatment

Loss of clinical attachment level

To assess further loss of clinical attachment level by the use of a periodontal probe

Data from ClinicalTrials.gov

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