Clinical trial NCT02518152: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: defect depth reduction (%)
timeFrame: Change from baseline to 9 months
Secondary outcomes:
measure: probing depth (mm)
timeFrame: Change from baseline to 9 months
measure: clinical attachment level (mm)
timeFrame: Change from baseline to 9 months
measure: gingival marginal level (mm)
timeFrame: Change from baseline to 9 months
measure: modified sulcus bleeding index
timeFrame: Change from baseline to 9 months
measure: plaque index
timeFrame: Change from baseline to 9 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
References: