Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis
Information source: Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Periodontitis
Intervention: Open flap debridement (OFD) (Procedure); OFD with Platelet rich fibrin (PRF) (Procedure); OFD with Platelet rich fibrin (PRF)+1% Alendronate (Procedure)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Government Dental College and Research Institute, Bangalore
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.
Clinical Details
Official title: Efficacy Of Platelet Rich Fibrin With 1% Alendronate For Treatment Of Intrabony Defects In Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: defect depth reduction (%)
Secondary outcome: probing depth (mm)clinical attachment level (mm) gingival marginal level (mm) modified sulcus bleeding index plaque index
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.
Eligibility
Minimum age: 30 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Government Dental College and Research Institute, Bangalore, Karnataka 560002, India
Additional Information
Starting date: October 2014
Last updated: August 6, 2015
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