DFDBA and Amniotic Membrane in the Treatment of Periodontal Osseous Defects
A Clinical and Radiographic Evaluation of DFDBA (Demineralised Freeze Dried Bone Allograft) With Amniotic Membrane (AM) in the Treatment of Periodontal Osseous Defects-12 Month Randomized Controlled Clinical Trial
1 other identifier
interventional
10
1 country
1
Brief Summary
Amniotic membrane may be considered as a biologically active scaffold, which in combination with Bone Replacement Grafts (BRG) can be widely used to reconstruct periodontal Intrabony Defects (IBDs), due to the presence of stem cells and growth factors. The goal of the present study was to evaluate if a biologic AM in combination with DFDBA applied in periodontal IBDs would enhance the regeneration of periodontium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2013
Typical duration for phase_4
1 active site
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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedDecember 21, 2015
December 1, 2015
2.2 years
December 7, 2015
December 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical attachment level (CAL)
Clinical attachment level measured in mm from cementoenamel junction to base of the pocket)
1 year
Secondary Outcomes (5)
Plaque index
1 year
Gingival index
1 year
Bleeding index
1 year
Pocket Probing depth
1 year
Bone Fill
1 year
Study Arms (2)
OFD + DFDBA
ACTIVE COMPARATORIntrabony defects treatment was carried out with OFD + DFDBA
OFD+DFDBA+AM
ACTIVE COMPARATORIntrabony defects treatment was carried out with OFD + DFDBA+ AM
Interventions
After Phase I therapy, patient's were assigned for OFD+DFDBA group. Mucoperiosteal flap were reflected.After Open Flap Debridement (OFD), DFDBA graft was placed for the treatment of intrabony defects.
After Phase I therapy, patient's were assigned for OFD+DFDBA + AM group. Mucoperiosteal flap were reflected. After Open Flap Debridement (OFD). DFDBA and AM was placed for the treatment of intrabony defects.
Eligibility Criteria
You may qualify if:
- Age group of 25-45 years
- Moderate periodontitis with pocket probing depth more than 6mm
- Bilaterally similar intrabony defects
- Systemically healthy patients
- Vital or endodontically treated teeth
- Good compliance
You may not qualify if:
- Medically compromised
- Pregnant and lactating women
- Smoking
- Teeth with mobility and furcation involvement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krishnadevaraya college of dental sciences and hospital
Bangalore, Karnataka, 562157, India
Related Publications (1)
Kiany F, Moloudi F. Amnion membrane as a novel barrier in the treatment of intrabony defects: a controlled clinical trial. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):639-47. doi: 10.11607/jomi.3590.
PMID: 26009915BACKGROUND
Related Links
Study Officials
- STUDY DIRECTOR
DR JOANN P GEORGE, MDS
Krishnadevaraya college of dental science and hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 21, 2015
Study Start
November 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
December 21, 2015
Record last verified: 2015-12