ClinicalTrials.gg
WithdrawnNCT04017429FURC-III-OSTUpdated Apr 30, 2021

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

An interventional study of Open flap debridement with osteoplasty and Open flap debridement without osteoplasty in Furcation Defects and Periodontal Diseases, sponsored by University of Oslo. Withdrawn at 1 site in Norway. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by University of Oslo · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Not feasible to recruit and follow-up subjects due to the pandemic
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Furcation Defects
  • Periodontal Diseases
03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

Browse Furcation Defects studies →

Lead sponsor

University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term treatment
  • Present or past use of bisphosphonate treatment
  • Pregnant or nursing subjects
  • Patients classified as > class II according to
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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 · Procedure: Open flap debridement without osteoplasty

  • 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 · Procedure: Open flap debridement without osteoplasty

Interventions

  • ProcedureOpen flap debridement with osteoplasty

    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.

  • ProcedureOpen flap debridement without osteoplasty

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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 12 months after treatment

  3. Loss of clinical attachment level

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

    Time frame: 12 months after treatment

  4. Loss of clinical attachment level

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

    Time frame: 24 months after treatment

  5. 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)

    Time frame: 24 months after treatment

  6. Radiographic changes

    To assess bone loss as measured on standardized radiographs (in mm)

    Time frame: 12 months after treatment

  7. Radiographic changes

    To assess bone loss as measured on standardized radiographs (in mm)

    Time frame: 24 months after treatment

07

Study locations

1 site
  • Institute of Clinical Dentistry, University of Oslo, Norway
    Oslo, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04017429
Lead sponsor
University of Oslo
Responsible party
Anders Verket (Associate Professor, PhD, University of Oslo) — Principal investigator
First posted
Jul 12, 2019
Start date
Oct 15, 2019
Primary completion
Jun 15, 2027 (estimated)
Completion
Jun 15, 2027 (estimated)
Last update
Apr 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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