Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis

Periodontitis Clinical Trial

Official title:

Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06153706
• Other study ID #: #6/22
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients suffering from stage II periodontitis with probing depth and exhibiting bleeding on probing.

• Patients showing good oral hygiene.

• No history of periodontal therapy (surgical and non-surgical) for the past 6 months.

Exclusion Criteria:

• Patients with known systemic and debilitating diseases.

• Patients who had any previous adverse reactions to the products (or similar products) used in this study.

• Patients who have any autoimmune diseases.

• Patients who have any known disease that interfere with periodontal procedure.

• Smokers.

• Pregnancy and lactating women.

• Use of antibiotics during the last 6 months.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• Subgingival application of L-PRF loaded with metronidazole
After phase I therapy, L-PRF loaded medical grade metronidazole was applied sub gingivally into the pockets using blunt gauge needle and Perio-pack was placed (two applications with one week apart were applied subgingivally.

Other:
• Subgingival application of L-PRF
The L-PRF alone was applied subgingivally into the pockets and Perio-pack was placed (two applications with one week apart.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Yasmeen Khaled

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque accumulation	This was assessed using O'Leary plaque index which is based on the visible continuous plaque along the gingival margin after staining. Four or six sites per tooth were examined, and the percentage of tooth surfaces exhibiting stained plaque was calculated. The score ranges from 0% (no plaque) to 100% (abundant plaque)	up to 6 months
Primary	Gingival inflammation	This was assessed using modified gingival index which uses a visual scale to assess gingival health. It relies on a visual assessment of gingival changes to measure the severity of inflammation. Five categories, using a 0-4 scale, score the marginal and papillary gingival tissue based on color, texture, edema, and spontaneous bleeding. Using this index, 108 sites are scored per person (52 papillary and 56 marginal sites). Score 0 indicates normal gingival, score 1: mild inflammation with slight changes in color and texture, but not in all portions of gingival marginal or papillary, score 2: Mild inflammation with slight changes in color and texture in all portions of gingival marginal or papillary, score 3: Moderate bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary, and score 4: Severe inflammation with erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration	up to 6 months
Primary	Bleeding on probing	This was assessed using bleeding index which assesses bleeding on probing. The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. The score ranges from 0% (no bleeding) to 100% (bleeding in all sites)	up to 6 months
Primary	Probing depth	The distance measured (mm) using a periodontal probe from the base of the pocket to the most apical point on the gingival margin. It dictates the patient's ability to maintain optimal plaque control. Probing depths in excess of 3mm are an indication for periodontal therapy.	up to 6 months
Primary	Clinical attachment loss	It represents the extent of periodontal support that has been lost around a tooth and is measured with the periodontal probe as the distance (mm) from the cemento-enamel junction to the base of the pocket	up to 6 months
Primary	Quantitative assessment of Porhyromonas gingivalis	Relative quantitation of Porhyromonas gingivalis counts was performed by Real Time PCR. Subgingival plaque samples were calculated, DNA was isolated and quantified for standardizing the polymerase chain reaction.	up to 6 months