Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Open flap debridement (OFD)
OFD with Platelet rich fibrin (PRF)
OFD with Platelet rich fibrin (PRF)+1% Alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion criteria
- Presence of 3-wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an Intra-oral Periapical Radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing[SRP]) in asymptomatic teeth.
Exclusion Criteria:
- Aggressive Periodontitis patients;
- Systemic conditions known to affect the periodontal status;
- medications known to affect the outcomes of periodontal therapy;
- Hematological disorders and insufficient platelet count (<200,000/mm3);
- Pregnancy/lactation;
- Smoking and tobacco use in any form
- Immunocompromised individuals.
- Those having unacceptable oral hygiene (plaque index27 [PI] >1.5) after reevaluation of Phase I therapy .
- Teeth with furcation involvement, non-vital teeth, carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Sites / Locations
- Government Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating periodontal defect
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating periodontal defect
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating periodontal defect
Outcomes
Primary Outcome Measures
defect depth reduction (%)
assessed in percentage
Secondary Outcome Measures
probing depth (mm)
measured in mm
clinical attachment level (mm)
measured in mm
gingival marginal level (mm)
measured in mm
modified sulcus bleeding index
scale from 0-3
plaque index
scale from 0-3
Full Information
NCT ID
NCT02518152
First Posted
August 4, 2015
Last Updated
August 6, 2015
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT02518152
Brief Title
Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis
Official Title
Efficacy Of Platelet Rich Fibrin With 1% Alendronate For Treatment Of Intrabony Defects In Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (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
No
5. Study Description
Brief Summary
The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.
Detailed Description
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate, act as reservoirs of growth factors and cytokines which are the key factors for regeneration of the bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.
Methods: Ninety patients with single defects were categorized into three groups: OFD alone, OFD with PRF,OFD with PRF+1% ALN. Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction (IBD) was evaluated at baseline and 9 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating periodontal defect
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating periodontal defect
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating periodontal defect
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement (OFD)
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD)
Intervention Type
Procedure
Intervention Name(s)
OFD with Platelet rich fibrin (PRF)
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
Intervention Type
Procedure
Intervention Name(s)
OFD with Platelet rich fibrin (PRF)+1% Alendronate
Intervention Description
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate placement into the bone defect
Primary Outcome Measure Information:
Title
defect depth reduction (%)
Description
assessed in percentage
Time Frame
Change from baseline to 9 months
Secondary Outcome Measure Information:
Title
probing depth (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
clinical attachment level (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
gingival marginal level (mm)
Description
measured in mm
Time Frame
Change from baseline to 9 months
Title
modified sulcus bleeding index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
Title
plaque index
Description
scale from 0-3
Time Frame
Change from baseline to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
Presence of 3-wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an Intra-oral Periapical Radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing[SRP]) in asymptomatic teeth.
Exclusion Criteria:
Aggressive Periodontitis patients;
Systemic conditions known to affect the periodontal status;
medications known to affect the outcomes of periodontal therapy;
Hematological disorders and insufficient platelet count (<200,000/mm3);
Pregnancy/lactation;
Smoking and tobacco use in any form
Immunocompromised individuals.
Those having unacceptable oral hygiene (plaque index27 [PI] >1.5) after reevaluation of Phase I therapy .
Teeth with furcation involvement, non-vital teeth, carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
12. IPD Sharing Statement
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Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis
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