Low-Level Laser Therapy and Injectable Platelet-Rich Fibrin for Thin Gingival Phenotype.

NCT06756854 | Completed Phase 3 FDA Drug

• 1 other identifier: P-ME-23-05
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Management of thin gingival phenotype using non-surgical methods (injection of liquid platelet rich fibrin and exposure to low level laser therapy

Conditions

Periodontal Diseases

Keywords

I-PRF, thin gingival phenotype low level laser

Outcome Measures

Primary Outcomes (2)

• Gingival thickness improvement in millimeters.

  clinical parameter

  6 months after treatment

• Keratinized tissue width improvement in millimeters.

  Clinincal parameter.

  6 months after treatment

Secondary Outcomes (3)

• Improvement of gingival index.

  6 months after treatment

• Improvement of bleeding on probing.

  6 months after treatment

• Improvement of sulcus depth.

  6 months after treatment

Study Arms (2)

Test group: injectable platelet rich fibrin+ low level laser therapy

ACTIVE COMPARATOR

patients with thin gingival phenotype (gingival thickness less than 1mm) recieve I-PRF+LLLT radiation just after the injection for 3 sessions with 7 days interval between the sessions.

Other: injecable platelet rich fibrin, and low level laser therapy radiation.

Control group :I-PRF group

ACTIVE COMPARATOR

patients with thin gingival phenotype received I-PRF alone in 3 sessions, with 7 days interval between the sessions.

Biological: Biologic Agent: injectable platelet rich fibrin.

Interventions

Biologic Agent: injectable platelet rich fibrin. BIOLOGICAL

injection of I-PRF to thin gingival phenotype 3 times with 7 days interval between sessions.

Also known as: Liquid platelet rich fibrin

Control group :I-PRF group

injecable platelet rich fibrin, and low level laser therapy radiation. OTHER

injection of I-PRF+ exposure to LLLT to thin gingival phenotype 3 times with 7 days interval between sessions.

Test group: injectable platelet rich fibrin+ low level laser therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• free systimatically good oral hygiene gingival thickness less than 1mm

You may not qualify if:

• pregnancy or lactation pereiodontitis periodontal surgery orthodontic ttt tooth mobility,bruxism,crowding,missing or supernumerary teeth smoking

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Alaa Elsayed

Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Eldawy, doctor

  MINDRAY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: I-PRF biologic product
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: periodontist

Model Details: group1: received I-PRF alone, and group 2: received I-PRF+LLLT

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: January 3, 2025
• Study Start: September 12, 2023
• Primary Completion: May 14, 2024
• Study Completion: June 15, 2024
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)