Rosuvastatin Gel With 1:1 Mixture of Platelet-rich Fibrin and Bone Graft in Mandibular Degree II Furcation Defects

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic statin, that stimulate bone formation in critical-size cortical bone defects adjacent to titanium implants, when administered locally in bone. Platelet-rich fibrin (PRF) is a platelet concentrate with sustained release of various growth factors, having regenerative potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material has clinically satisfactory response, when used to fill periodontal intrabony defects. This double-masked randomized study is designed to evaluate the potency of combination of RSV 1.2mg in situ gel with 1:1 mixture of autologous PRF and HA bone graft in the surgical treatment of mandibular degree II furcation defects when compared with autologous PRF and HA bone graft placed after open flap debridement (OFD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Government Dental College and Research Institute, Bangalore
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. the presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with PD ± 5mm and horizontal PD ± 3mm after Phase I therapy (SRP)

2. no history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

1. systemic illness known to affect the outcomes of periodontal therapy, such as diabetes mellitus, cardiac diseases, insufficient platelet count (<200,000/mm3), or immunocompromised (e.g., HIV individuals) patients taking medications, such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing

2. individuals known or suspected allergy to the RSV group or allergic to medications

3. systemic statin therapy

4. pregnant or lactating women

5. patients using tobacco in any form

6. individuals with unacceptable oral hygiene (plaque index >1.5). In addition, teeth with interproximal intrabony defects, gingival recession, endodontic (pulpal) involvement, or mobility of tooth ≥ Grade II were also excluded.