NCT06270303

Brief Summary

The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone? 200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
131mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2025Mar 2037

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 27, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2037

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

February 13, 2024

Last Update Submit

August 20, 2025

Conditions

PeriodontitisFurcation Defects

Keywords

Surgical therapyReconstructiveRandomized controlled trial

Outcome Measures

Primary Outcomes (6)

  • Proportion of patients/teeth displaying furcation closure.

    Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.

    6 months.

  • Proportion of patients/teeth displaying furcation closure.

    Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.

    12 months.

  • Proportion of patients/teeth displaying furcation closure.

    Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.

    3 years.

  • Proportion of patients/teeth displaying furcation closure.

    Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.

    5 years.

  • Proportion of patients/teeth displaying furcation closure.

    Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.

    7 years.

  • Proportion of patients/teeth displaying furcation closure.

    Furcation closure defined as absence of clinically detectable furcation involvement degree \>I.

    10 years.

Secondary Outcomes (48)

  • Changes in probing pocket depth.

    6 months.

  • Changes in probing pocket depth.

    12 months.

  • Changes in probing pocket depth.

    3 years.

  • Changes in probing pocket depth.

    5 years.

  • Changes in probing pocket depth.

    7 years.

  • +43 more secondary outcomes

Study Arms (2)

Access flap + bone substitute

EXPERIMENTAL

Furcation defect will be treated by access flap debridement followed by application of a bone substitute material.

Procedure: Access flap & surgical debridementProcedure: Application of bone substitute material (BioOss Collagen)

Access flap

ACTIVE COMPARATOR

Furcation defect will be treated by access flap debridement alone.

Procedure: Access flap & surgical debridement

Interventions

Access flap & surgical debridementPROCEDURE

Following surgical exposure, roots are carefully debrided.

Access flapAccess flap + bone substitute
Application of bone substitute material (BioOss Collagen)PROCEDURE

Following surgical debridement, the bone substitute material is applied to the furcation defect.

Access flap + bone substitute

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should present with at least one surgically accessible molar (in tooth position 6 or 7) diagnosed with a single furcation defect degree II (at any aspect).
  • Following initial periodontal therapy, teeth to be included should present with one site with furcation defect degree II in combination with:
  • Bleeding on probing
  • Probing pocket depth of ≥6 mm
  • Soft tissue coverage of the furcation entrance Patients should present with a full mouth plaque score ≤25%.

You may not qualify if:

  • Multiple deep furcation defects (degree II - III) at the same tooth
  • Vertical attachment loss \>50% at aspects not facing the furcation defect
  • Defects presenting with apico-marginal communication
  • Intake of systemic antibiotics within 6 months
  • Systemic conditions/medication impeding surgical intervention (e.g. uncontrolled diabetes, immunosuppressive medication)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, Institute of Odontology

Gothenburg, 40530, Sweden

RECRUITING

MeSH Terms

Conditions

PeriodontitisFurcation Defects

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Karolina Karlsson, PhD

    Göteborg University

    STUDY DIRECTOR

Central Study Contacts

Jan Derks, PhD

CONTACT

+46766183124‬jan.derks@odontologi.gu.se

Kostas Bougas, PhD

CONTACT

+46766181208kostas.bougas@gu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinical assessments following intervention will be conducted by assessors unaware of group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The project will be conducted as a two-armed randomized controlled trial in multiple clinical centers. The primary outcome will be assessed at 1 year post-surgery with a subsequent follow-up of 10 years.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 21, 2024

Study Start

March 27, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2037

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)