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

NCT02369250 | Completed Phase 4 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/12/2013-14
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Furcation Defects

Keywords

regeneration; surgical therapy; furcation defect

Outcome Measures

Primary Outcomes (1)

• BONE FILL

  BONE FILL/ defect depth reduction recorded at baseline and at 9 months

  9 MONTHS

Secondary Outcomes (2)

• Probing depth

  9 months

• Clinical attachment level

  9 months

Study Arms (3)

OFD+ PLACEBO GEL

PLACEBO COMPARATOR

furcation defect site is surgically debrid and placed a placebo gel

OFD+ PRF + BONE GRAFT

ACTIVE COMPARATOR

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

RSV1.2% gel + PRF+ BG

EXPERIMENTAL

Following surgical debridment of furcation site Rosuvastatin 1.2% in situ gel combined with autologous PRF and bone graft is placed

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Rosuvastatin, is a statin group of drug.

Also known as: statin

RSV1.2% gel + PRF+ BG

platelet rich fibrin BIOLOGICAL

AUTOLOGUS PLATELET GROWTH FACTOR

Also known as: platelet concentrate

OFD+ PRF + BONE GRAFT

Eligibility Criteria

• Age: 26 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Furcation Defects

Interventions

Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor and Head, dept of periodontology

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: February 23, 2015
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 23, 2015

Record last verified: 2015-02