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

NCT02518152 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014N
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• defect depth reduction (%)

  assessed in percentage

  Change from baseline to 9 months

Secondary Outcomes (5)

• probing depth (mm)

  Change from baseline to 9 months

• clinical attachment level (mm)

  Change from baseline to 9 months

• gingival marginal level (mm)

  Change from baseline to 9 months

• modified sulcus bleeding index

  Change from baseline to 9 months

• plaque index

  Change from baseline to 9 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating periodontal defect

Procedure: Open flap debridement (OFD)

Group 2

ACTIVE COMPARATOR

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating periodontal defect

Procedure: OFD with Platelet rich fibrin (PRF)

Group 3

ACTIVE COMPARATOR

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

Interventions

Open flap debridement (OFD) PROCEDURE

Oral prophylaxis followed by Open flap debridement (OFD)

Group 1

OFD with Platelet rich fibrin (PRF) PROCEDURE

Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect

Group 2

OFD with Platelet rich fibrin (PRF)+1% Alendronate PROCEDURE

Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate placement into the bone defect

Group 3

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 7, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

IN (1)