search
Back to results

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

Primary Purpose

Furcation Defects

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rosuvastatin
platelet rich fibrin
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects focused on measuring regeneration, surgical therapy, furcation defect

Eligibility Criteria

26 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    OFD+ PLACEBO GEL

    OFD+ PRF + BONE GRAFT

    RSV1.2% gel + PRF+ BG

    Arm Description

    furcation defect site is surgically debrid and placed a placebo gel

    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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Probing depth
    Probing depth recorded at baselin and at 9 months
    Clinical attachment level
    Gain in Clinical attachment level from cementoenamel junction to the base of the periodontal pocket

    Full Information

    First Posted
    December 4, 2014
    Last Updated
    February 17, 2015
    Sponsor
    Government Dental College and Research Institute, Bangalore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02369250
    Brief Title
    Rosuvastatin Gel With 1:1 Mixture of Platelet-rich Fibrin and Bone Graft in Mandibular Degree II Furcation Defects
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Government Dental College and Research Institute, Bangalore

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Furcation Defects
    Keywords
    regeneration, surgical therapy, furcation defect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OFD+ PLACEBO GEL
    Arm Type
    Placebo Comparator
    Arm Description
    furcation defect site is surgically debrid and placed a placebo gel
    Arm Title
    OFD+ PRF + BONE GRAFT
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    RSV1.2% gel + PRF+ BG
    Arm Type
    Experimental
    Arm Description
    Following surgical debridment of furcation site Rosuvastatin 1.2% in situ gel combined with autologous PRF and bone graft is placed
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin
    Other Intervention Name(s)
    statin
    Intervention Description
    Rosuvastatin, is a statin group of drug.
    Intervention Type
    Biological
    Intervention Name(s)
    platelet rich fibrin
    Other Intervention Name(s)
    platelet concentrate
    Intervention Description
    AUTOLOGUS PLATELET GROWTH FACTOR
    Primary Outcome Measure Information:
    Title
    BONE FILL
    Description
    BONE FILL/ defect depth reduction recorded at baseline and at 9 months
    Time Frame
    9 MONTHS
    Secondary Outcome Measure Information:
    Title
    Probing depth
    Description
    Probing depth recorded at baselin and at 9 months
    Time Frame
    9 months
    Title
    Clinical attachment level
    Description
    Gain in Clinical attachment level from cementoenamel junction to the base of the periodontal pocket
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs