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
About this trial
This is an interventional treatment trial for Furcation Defects focused on measuring regeneration, surgical therapy, furcation defect
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.
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
NCT ID
NCT02369250
First Posted
December 4, 2014
Last Updated
February 17, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
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
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