Clinical trial NCT02283554: Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects
Official title: Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Keywords: Periodontal Surgery
Periodontal Regeneration
Growth factors
Clinical trials
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: radiographic defect depth reduction from baseline to 9 months.
timeFrame: radiographic defect depth reduction from baseline to 9 months.
Secondary outcomes:
measure: Change in PD
timeFrame: Assessment of PD at 3,6 and 9 months
measure: Change in RAL
timeFrame: Assessment of RAL at 3,6 and 9 months
measure: Change in GML
timeFrame: Assessment of GML at 3,6 and 9 months
measure: Change in mSBI
timeFrame: Assessment of mSBI at 3,6 and 9 months
measure: Cgange in PI
timeFrame: Assessment of PI at 3,6 and 9 months
Other outcomes:
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