Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects

Periodontitis Clinical Trial

Official title:

Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283554
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014B
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2014
• Last updated: November 4, 2014
• Start date: November 2013

Study information

• Verified date: November 2014
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

ABSTRACT:

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects.

Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Presence of 3- wall intrabony defects =3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA] ) along with an interproximal probing depth (PD) =5 mm after phase I therapy (scaling and root planing [SRP] ) in asymptomatic molar teeth.

Exclusion Criteria:

• Aggressive Periodontitis subjects

• Subjects with systemic conditions known to affect the periodontal status

• Medications known to affect the outcomes of periodontal therapy

• Hematological disorders and insufficient platelet count (<200,000/mm3)

• Pregnancy/lactation

• Smoking and tobacco use in any form

• Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index [PI]16 > 1.5) after re-evaluation of Phase I therapy were also excluded from the study.

• In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• open flap debridement (OFD)

Other:
• Platelet rich fibrin (PRF)

Drug:
• Metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic defect depth reduction from baseline to 9 months.	The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months	radiographic defect depth reduction from baseline to 9 months.	No
Secondary	Change in PD	PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt	Assessment of PD at 3,6 and 9 months	No
Secondary	Change in RAL	RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base	Assessment of RAL at 3,6 and 9 months	No
Secondary	Change in GML	Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe	Assessment of GML at 3,6 and 9 months	No
Secondary	Change in mSBI	mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months	Assessment of mSBI at 3,6 and 9 months	No
Secondary	Cgange in PI	PI is assessed by noting the amount of plaque and the site of plaque present on the tooth surface at 3,6 and 9 months	Assessment of PI at 3,6 and 9 months	No