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

NCT02283554 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014B
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Keywords

Periodontal Surgery; Periodontal Regeneration; Growth factors; Clinical trials

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Change in PD

  Assessment of PD at 3,6 and 9 months

• Change in RAL

  Assessment of RAL at 3,6 and 9 months

• Change in GML

  Assessment of GML at 3,6 and 9 months

• Change in mSBI

  Assessment of mSBI at 3,6 and 9 months

• Cgange in PI

  Assessment of PI at 3,6 and 9 months

Study Arms (4)

ARM1- open flap debridement (OFD)

PLACEBO COMPARATOR

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

Procedure: open flap debridement (OFD)

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

EXPERIMENTAL

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

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

ARM3- open flap debridement plus 1%Metformin

EXPERIMENTAL

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

Procedure: open flap debridement (OFD); Drug: Metformin

ARM4- open flap debridement plus PRF plus metformin

EXPERIMENTAL

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

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

Interventions

open flap debridement (OFD) PROCEDURE

ARM1- open flap debridement (OFD); ARM2- open flap debridement plus PRF(Platelet rich fibrin); ARM3- open flap debridement plus 1%Metformin; ARM4- open flap debridement plus PRF plus metformin

Platelet rich fibrin (PRF) OTHER

ARM2- open flap debridement plus PRF(Platelet rich fibrin); ARM4- open flap debridement plus PRF plus metformin

Metformin DRUG

ARM3- open flap debridement plus 1%Metformin; ARM4- open flap debridement plus PRF plus metformin

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and head, department of periodontics

Study Record Dates

• First Submitted: September 27, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Last Updated: November 5, 2014

Record last verified: 2014-11