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

December 25, 2024 updated by: Alaa Elsayed, Faculty of Dental Medicine for Girls

Evaluation of Low-Level Laser Therapy as Adjunctive to the Injectable Platelet-Rich Fibrin in the Management of Patients With Thin Gingival Phenotype.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thin gingival phenotype can lead to recession and root exposure. Liquid prf can be obtained by centrifugion of blood sample on speed 700 rpm for 3 min, then injection of this liquid in the attached gingiva and muco-gingival junction (3 times with 7 days interval) for the first group. The second group will be injected with I-PRF in the same method in addition to exposure to Low Level Laser therapy (after each injection of I-PRF). This method is expected to increase the thickness of the gingiva.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Alaa Elsayed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test group: injectable platelet rich fibrin+ low level laser therapy
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.
injection of I-PRF+ exposure to LLLT to thin gingival phenotype 3 times with 7 days interval between sessions.
Active Comparator: Control group :I-PRF group
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.
injection of I-PRF to thin gingival phenotype 3 times with 7 days interval between sessions.
Other Names:
  • Liquid platelet rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival thickness improvement in millimeters.
Time Frame: 6 months after treatment
clinical parameter
6 months after treatment
Keratinized tissue width improvement in millimeters.
Time Frame: 6 months after treatment
Clinincal parameter.
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of gingival index.
Time Frame: 6 months after treatment
Clinical parameter.
6 months after treatment
Improvement of bleeding on probing.
Time Frame: 6 months after treatment
Clinical parameter.
6 months after treatment
Improvement of sulcus depth.
Time Frame: 6 months after treatment
Clinical parameter.
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Principal Investigator: Ahmed Eldawy, doctor, MINDRAY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Actual)

May 14, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 25, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-ME-23-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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