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

NCT ID: NCT02283554

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30

Brief 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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ARM1- open flap debridement (OFD)

open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect.

Group Type: PLACEBO_COMPARATOR

open flap debridement (OFD)

Intervention Type: PROCEDURE

ARM2- open flap debridement plus PRF(Platelet rich fibrin)

After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect.

No. of subjects= 30

Group Type: EXPERIMENTAL

open flap debridement (OFD)

Intervention Type: PROCEDURE

Platelet rich fibrin (PRF)

Intervention Type: OTHER

ARM3- open flap debridement plus 1%Metformin

After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30

Group Type: EXPERIMENTAL

open flap debridement (OFD)

Intervention Type: PROCEDURE

Metformin

Intervention Type: DRUG

ARM4- open flap debridement plus PRF plus metformin

After open flap debridement, PRF and 1% metformin was added into the intrabony defect.

No. of subject- 30

Group Type: EXPERIMENTAL

open flap debridement (OFD)

Intervention Type: PROCEDURE

Platelet rich fibrin (PRF)

Intervention Type: OTHER

Metformin

Intervention Type: DRUG

Interventions

open flap debridement (OFD)

Intervention Type: PROCEDURE

Platelet rich fibrin (PRF)

Intervention Type: OTHER

Metformin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role: lead

Responsible Party

Dr. A R Pradeep

Professor and head, department of periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GDCRI/ACM/PG/PhD/2/2013-2014B

Identifier Type: -

Identifier Source: org_study_id