Furcation DefectsFURC-III-OSTNCT04017429
Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade III Furcation Defects (FURC-III-OST)
A study testing Open flap debridement with osteoplasty and Open flap debridement without osteoplasty in people with Furcation Defects and Periodontal Diseases, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects, Periodontal Diseases
- What is being tested?
- Open flap debridement with osteoplasty and Open flap debridement without osteoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- 15 Oct 2019to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Grade III Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement
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.
- Conditions
- Furcation Defects, Periodontal Diseases
- Being tested
- Open flap debridement with osteoplasty, Open flap debridement without osteoplasty
- Medical subject headings
- Furcation Defects, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap debridement with osteoplastyProcedure or surgery
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 or surgery
Treatment of furcation grade III defect with open flap debridement only.
| Study group | Role | What they receive |
|---|---|---|
| Open flap debridement with osteoplasty | Experimental | In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area. Receives: 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. Receives: Procedure: Open flap debridement with osteoplasty; Procedure: Open flap debridement without osteoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sites with no signs of inflammation
Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment
Measured: 12 months after treatment
Sites with no signs of inflammation
Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment
Measured: 24 months after treatment
Secondary outcomes (7)
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)
Measured: Preoperatively compared to 24 months after treatment
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)
Measured: 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
Measured: 12 months after treatment
Loss of clinical attachment level
To assess further loss of clinical attachment level by the use of a periodontal probe
Measured: 24 months after treatment
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)
Measured: 24 months after treatment
Radiographic changes
To assess bone loss as measured on standardized radiographs (in mm)
Measured: 12 months after treatment
Radiographic changes
To assess bone loss as measured on standardized radiographs (in mm)
Measured: 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start15 Oct 2019
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Why it stopped: Not feasible to recruit and follow-up subjects due to the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Verket, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017429
- Sponsor's protocol ID
- FURC-III-OST
- Acronym
- FURC-III-OST
- Status last verified
- Apr 2021
- First submitted
- 8 Jul 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Grade III Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement
- ClinicalTrials.gov ID
- NCT04017429
- Acronym / sponsor ID
- FURC-III-OST / FURC-III-OST
- Conditions
- Furcation Defects, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasible to recruit and follow-up subjects due to the pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open flap debridement with osteoplasty | Experimental | Procedure: Open flap debridement with osteoplasty, Procedure: Open flap debridement without osteoplastyIn this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area. |
| Open flap debridement without osteoplasty | Active comparator | Procedure: Open flap debridement with osteoplasty, Procedure: Open flap debridement without osteoplastyIn this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open flap debridement with osteoplastyTreatment 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. | Procedure or surgery | Open flap debridement with osteoplasty, Open flap debridement without osteoplasty |
| Open flap debridement without osteoplastyTreatment of furcation grade III defect with open flap debridement only. | Procedure or surgery | Open flap debridement with osteoplasty, Open flap debridement without osteoplasty |
Primary outcome
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
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
7 secondary outcomes
Changes in patient-reported quality of life (QoL)
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
Time frame: 12 months after treatment
Loss of clinical attachment level
Time frame: 24 months after treatment
Number of participants with caries lesions
Time frame: 24 months after treatment
Radiographic changes
Time frame: 12 months after treatment
Radiographic changes
Time frame: 24 months after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open flap debridement with osteoplasty and Open flap debridement without osteoplasty in people with Furcation Defects and Periodontal Diseases, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sites with no signs of inflammation (time frame: 12 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.