Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518152
Recruitment Status : Completed
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Open flap debridement (OFD) Procedure: OFD with Platelet rich fibrin (PRF) Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate Phase 2 Phase 3

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Of Platelet Rich Fibrin With 1% Alendronate For Treatment Of Intrabony Defects In Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study Start Date : October 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Group 1
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating periodontal defect
 Procedure: Open flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)
Active Comparator: Group 2
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating periodontal defect
 Procedure: OFD with Platelet rich fibrin (PRF)
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
Active Comparator: Group 3
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating periodontal defect
 Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate placement into the bone defect


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. defect depth reduction (%) [ Time Frame: Change from baseline to 9 months ]
    assessed in percentage


Secondary Outcome Measures :
  1. probing depth (mm) [ Time Frame: Change from baseline to 9 months ]
    measured in mm

  2. clinical attachment level (mm) [ Time Frame: Change from baseline to 9 months ]
    measured in mm

  3. gingival marginal level (mm) [ Time Frame: Change from baseline to 9 months ]
    measured in mm

  4. modified sulcus bleeding index [ Time Frame: Change from baseline to 9 months ]
    scale from 0-3

  5. plaque index [ Time Frame: Change from baseline to 9 months ]
    scale from 0-3


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518152


Locations
Layout table for location information
India
Government Dental College and Research Institute
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. A R Pradeep, Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02518152    
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014N
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
 Stomatognathic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs