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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03207698
Other study ID # GDCRI/ACM/PG/PhD/2/2013-2014KD
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 1, 2017
Last updated July 1, 2017
Start date September 2015
Est. completion date May 2016

Study information

Verified date July 2017
Source Government Dental College and Research Institute, Bangalore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.


Description:

Background: For improving efficacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria:

- Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) = 5mm and horizontal = PD 3mm after phase I therapy i.e, scaling and root planing (SRP);

- No history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

Aggressive periodontitis patients

- Systemic conditions known to affect the periodontal status;

- Medications known to affect the outcomes of periodontal therapy;

- Hematological disorders and insufficient platelet count (<100,000/mm3);

- Pregnancy/lactation;

- Smoking and tobacco use in any form

- Immunocompromised individuals;

- Those having unacceptable oral hygiene (plaque index [PI] >1.5).

- Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Open flap debridement (OFD)
Open flap debridement (OFD) alone
OFD with Platelet rich fibrin (PRF)
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

Locations

Country Name City State
India Government Dental College and Research Institute Bangalore Karnataka

Sponsors (1)

Lead Sponsor Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic bone fill assessed in percentage assessed in percentage baseline to 9 months
Secondary probing depth measured in mm measured in mm baseline to 9 months
Secondary Relative vertical attachment level measured in mm measured in mm baseline to 9 months
Secondary Relative horizontal attachment level measured in mm measured in mm baseline to 9 months
Secondary modified sulcus bleeding index 0-3 scale baseline to 9 months
Secondary plaque index 0-3 scale baseline to 9 months
See also
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Completed NCT02369250 - Rosuvastatin Gel With 1:1 Mixture of Platelet-rich Fibrin and Bone Graft in Mandibular Degree II Furcation Defects Phase 4
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Recruiting NCT03180658 - Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans N/A
Active, not recruiting NCT05259982 - Vital Root-resective Therapy in Furcation-involved Maxillary Molars N/A
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Completed NCT02102360 - Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial. Phase 4
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Completed NCT03354182 - Surgical Treatment of Mandibular Furcations Using a Xenograft With/Without a Collagen Membrane N/A
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