NCT04059445

Brief Summary

Teeth with furcation grade II defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 9, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

4.1 years

First QC Date

July 9, 2019

Last Update Submit

November 27, 2023

Conditions

Furcation DefectsPeriodontal Diseases

Outcome Measures

Primary Outcomes (2)

  • Change of furcation grade level

    Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe

    12 months after treatment

  • Change of furcation grade level

    Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe

    24 months after treatment

Secondary Outcomes (12)

  • 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

  • Changes in defect morphology assessed by CBCT

    24 months after treatment

  • Changes in CAL

    12 months after treatment

  • Changes in CAL

    24 months after treatment

  • +7 more secondary outcomes

Study Arms (2)

Regenerative therapy w/BCP and collagen membrane

EXPERIMENTAL

In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.

Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)

Regenerative therapy w/BCP and enamel matrix proteins

ACTIVE COMPARATOR

In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.

Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)

Interventions

Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)DEVICE

Regenerative therapy with biphasic calcium phosphate + collagen membrane.

Regenerative therapy w/BCP and collagen membraneRegenerative therapy w/BCP and enamel matrix proteins
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)DRUG

Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.

Regenerative therapy w/BCP and collagen membraneRegenerative therapy w/BCP and enamel matrix proteins

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be ≥ 20 years
  • Subject must have periodontal disease as determined by the World Workshop 2017 criteria
  • Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD \>4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
  • Competent to give consent

You may not qualify if:

  • The following must not be present at the time of enrolment;
  • 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 2 according to the ASA (American Society of Anesthesiologists) physical status 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 infractions
  • Caries lesions in the furcation area
  • No systemic antibiotic treatment within 3 months prior to intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oslo, 0455, Norway

Location

MeSH Terms

Conditions

Furcation DefectsPeriodontal Diseases

Interventions

hydroxyapatite-beta tricalcium phosphateenamel matrix proteins

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 9, 2019

First Posted

August 16, 2019

Study Start

October 15, 2019

Primary Completion

November 27, 2023

Study Completion

November 27, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

NO(1)