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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03578744
Other study ID # PMIDS
Secondary ID 16201105031D
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2017
Est. completion date October 30, 2018

Study information

Verified date November 2018
Source Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is intended to compare the efficacy of platelet-rich fibrin as a graft and a membrane versus hyaluronic acid(Gengigel) and amniotic membrane in the treatment of mandibular grade II furcation defects.


Description:

Platelet-rich fibrin is a fraction of plasma that provides a rich source of growth factors and may enhance the stabilization and revascularization of the flaps and grafts.

Hyaluronic acid is a naturally occurring non-sulfated high molecular weight glycosaminoglycan that forms a critical component of the extracellular matrix and contributes significantly to tissue hydrodynamics, cell migration and proliferation. Hence its administration to periodontal wound sites could achieve beneficial effects in periodontal tissue regeneration.

Amniotic membrane is being used for various regenerative procedures as it is a rich source of various collagen and non-collagen proteins such as laminin, fibronectin and proteoglycan.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 30, 2018
Est. primary completion date August 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria:

- Grade II furcation involvement

Exclusion Criteria:

- Smokers,

- Pregnant and lactating women,

- Systemically compromised patients

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional Flap surgery
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the furcation defects. The furcation defects would then be debrided and the graft and membrane secured in position. Later the flap would be sutured back.

Locations

Country Name City State
India Dr.Rekha Rani Koduganti Hyderabad Telangana

Sponsors (1)

Lead Sponsor Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & Publications (2)

Kothiwale SV, Anuroopa P, Gajiwala AL. A clinical and radiological evaluation of DFDBA with amniotic membrane versus bovine derived xenograft with amniotic membrane in human periodontal grade II furcation defects. Cell Tissue Bank. 2009 Nov;10(4):317-26. doi: 10.1007/s10561-009-9126-3. Epub 2009 Mar 10. — View Citation

Sharma A, Pradeep AR. Autologous platelet-rich fibrin in the treatment of mandibular degree II furcation defects: a randomized clinical trial. J Periodontol. 2011 Oct;82(10):1396-403. doi: 10.1902/jop.2011.100731. Epub 2011 Feb 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Radiological Parameters Amount of Bone fill in the furcation (Change in Bone level) to be measured by Cone Beam Computed Tomography(CBCT) Baseline and 9 months post surgery.
Secondary Clinical Parameter Change in relative vertical clinical attachment level will be measured by Williams probe in millimeters in the furcation area. Baseline and 9 months post surgery.
Secondary Clinical Parameter Change in relative horizontal clinical attachment level will be measured in millimeters by the Nabers probe in the furcation area Baseline and 9 months post surgery
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