Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

CHRONIC PERIODONTITIS Clinical Trial

Official title:

Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04070729
• Other study ID #: IEC/IDS50/2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: January 25, 2020

Study information

• Verified date: August 2019
• Source: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.

120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.

Description:

The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 25, 2020
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients are in general good health.

• Patients having minimum of 20 permanent teeth.

• They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.

• Presence of periodontal pockets (=5 mm) and clinicala ttachment level > 5 mm.

Exclusion Criteria:

• Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)

• Clotting and Hematological disorders

• Patients with grade III mobility.

• Patients with smoking and alcohol consuming habit.

• Pregnant and lactating female.

• Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)

• The teeth with poor filling and ill fitted restorations

Related Conditions & MeSH terms

• CHRONIC PERIODONTITIS
• Periodontitis

Intervention

Other:
• Placebo gel
Localized subgingival application

Drug:
• Hyaluronic acid gel
Localized subgingival application

Biological:
• Platelet rich fibrin
Localized subgingival application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level (CAL)	Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")	3 Months
Secondary	Probing pocket depth	Measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")	3 Months