Periodontitis
Conditions
Keywords
Periodontal Surgery, Periodontal Regeneration, Growth factors, Clinical trials
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.
Interventions
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiographic defect depth reduction from baseline to 9 months. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PD | Assessment of PD at 3,6 and 9 months | PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt |
| Change in RAL | Assessment of RAL at 3,6 and 9 months | RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base |
| Change in GML | Assessment of GML at 3,6 and 9 months | Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe |
| Change in mSBI | Assessment of mSBI at 3,6 and 9 months | mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months |
| Cgange in PI | Assessment of PI at 3,6 and 9 months | 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 |
Outcome results
None listed