NCT03180658

Brief Summary

Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars will be included and randomly divided into two groups. The experimental group will accept GTR + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The clinical examination and cone beam computed tomography (CBCT) will be performed at baseline and 1 year post-surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 1, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

May 29, 2017

Last Update Submit

June 7, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • clinical measurement

    Probing depth

    1 year

  • clinical parameter

    clinical attachment loss

    1 year

Secondary Outcomes (1)

  • radiographic parameter

    1 year

Study Arms (2)

experimental

EXPERIMENTAL

GTR+CGF+bone graft, CGF

Procedure: GTR + CGF + bone graft

controlled

ACTIVE COMPARATOR

CGF+bone graft

Procedure: CGF + bone graft

Interventions

Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements

Also known as: CGF Centrifuge machine
experimental

CGF combined with bone graft to treat mandibular furcation involvements

Also known as: CGF Centrifuge machine
controlled

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • II° furcation involvements in mandibular molars
  • after periodontal therapy.

You may not qualify if:

  • not healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

RECRUITING

MeSH Terms

Conditions

Furcation Defects

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • yan zu zhang, doctor

    dean

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 8, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations