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

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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

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.


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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


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




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



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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.

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
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India
Government Dental College and Research Institute
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore

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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     History of Changes
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:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs