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

Study Overview
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Brief Summary
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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).

Detailed Description
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ABSTRACT Background: A wide range of regenerative materials have been tried in the treatment of furcation defects. 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). Material and methods 105 patients with mandibular buccal Class II furcation defects were randomly allotted and treated either with, OFD and placebo gel: Group 1, or OFD + autologous PRF and porus-HA bone graft: Group 2, or OFD + RSV 1.2mg in situ gel combined with autologous PRF and porus-HA bone graft: Group 3. Clinical parameters were recorded at baseline before SRP and at 9 months; they included modified sulcus bleeding index (mSBI), probing depth (PD), and relative vertical (RVAL) and horizontal (RHAL) attachment levels. At baseline and after 9 months, radiographic assessment of bone defect fill was performed postoperatively.

Official Title
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Rosuvastatin 1.2mg in Situ Gel Combined With 1:1 Mixture of Autologous Platelet-rich Fibrin and Porus- Hydroxyappatite Bone Graft in Surgical Treatment of Mandibular Degree II Furcation Defects: A Randomized Clinical Control Trial

Conditions
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Furcation Defects

Intervention / Treatment
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* Drug: Rosuvastatin
* Biological: platelet rich fibrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) no history of antibiotic or periodontal therapy in the preceding 6 months. Exclusion Criteria: 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 individuals known or suspected allergy to the RSV group or allergic to medications systemic statin therapy pregnant or lactating women patients using tobacco in any form 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.

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: OFD+ PLACEBO GEL<br>furcation defect site is surgically debrid and placed a placebo gel | |
| Active Comparator: OFD+ PRF + BONE GRAFT<br>Following surgical debridment of furcation site autologous PRF and bone graft is placed in defect as a competator drug used is platelet rich fibrin and porus hydroxyapatite bone graft | Biological: platelet rich fibrin<br>* AUTOLOGUS PLATELET GROWTH FACTOR<br>* Other names: platelet concentrate;|
| Experimental: RSV1.2% gel + PRF+ BG<br>Following surgical debridment of furcation site Rosuvastatin 1.2% in situ gel combined with autologous PRF and bone graft is placed | Drug: Rosuvastatin<br>* Rosuvastatin, is a statin group of drug.<br>* Other names: statin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BONE FILL | BONE FILL/ defect depth reduction recorded at baseline and at 9 months | 9 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth recorded at baselin and at 9 months | 9 months | 
| Clinical attachment level | Gain in Clinical attachment level from cementoenamel junction to the base of the periodontal pocket | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regeneration, surgical therapy, furcation defect