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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 2

Conditions: Periodontitis

Treatments: Drug: Metformin; Other: Platelet rich fibrin (PRF); Procedure: open flap debridement (OFD)

Study type: Interventional

Funder types: Other

Identifiers

NCT02283554

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

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

ARM1- open flap debridement (OFD)

Placebo Comparator group

Description:

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

Treatment:

Procedure: open flap debridement (OFD)

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

Experimental group

Description:

After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30

Treatment:

Procedure: open flap debridement (OFD)

Other: Platelet rich fibrin (PRF)

ARM3- open flap debridement plus 1%Metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Procedure: open flap debridement (OFD)

ARM4- open flap debridement plus PRF plus metformin

Experimental group

Description:

After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30

Treatment:

Drug: Metformin

Procedure: open flap debridement (OFD)

Other: Platelet rich fibrin (PRF)