Adjunct Use of Diode Laser Therapy and Omega 3 Gel in Local Drug Delivery Approach on The Treatment of Localized Aggressive Periodontitis

NCT07056257 | Completed

• 1 other identifier: R-OMPDR-4-22-11
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate and compare the effect of combination therapy between diode laser and omega3 gel in the local drug delivery approach as an adjunct to scaling and root planning on the management of localized aggressive periodontitis clinically and immunologically.

Conditions

Diode Laser Therapy; Omega 3; Localized Aggressive Periodontitis

Outcome Measures

Primary Outcomes (1)

• Pocket depth

  Probing pocket depth (PD) was recorded according to Ramfijord 1967.

  6 months post-procedure

Secondary Outcomes (3)

• Plaque score

  6 months post-procedure

• Bleeding on probing

  6 months post-procedure

• Clinical attachment level loss

  6 months post-procedure

Study Arms (4)

Group I

ACTIVE COMPARATOR

Thirteen sites \[scaling-root planning (SRP)\] were used as a control group.

Procedure: Scaling-root planning (SRP)

Group II

EXPERIMENTAL

Thirteen sites \[scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month\].

Procedure: Scaling-root planning (SRP)+ laser therapy

Group III

EXPERIMENTAL

Thirteen sites \[scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month\].

Procedure: Scaling-root planning (SRP)+ omega 3 gel

Group IV

EXPERIMENTAL

Thirteen sites \[combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month\].

Procedure: Scaling-root planning (SRP)+ laser therapy+ omega 3 gel

Interventions

Scaling-root planning (SRP) PROCEDURE

Thirteen sites \[scaling-root planning (SRP)\] were used as a control group.

Group I

Scaling-root planning (SRP)+ laser therapy PROCEDURE

Thirteen sites \[scaling-root planning (SRP)+ laser therapy with application of methyl cellulose gel at repeated times weekly for one month\].

Group II

Scaling-root planning (SRP)+ omega 3 gel PROCEDURE

Thirteen sites \[scaling-root planning (SRP) + omega 3 gel repeated time weekly for one month\].

Group III

Scaling-root planning (SRP)+ laser therapy+ omega 3 gel PROCEDURE

Thirteen sites \[combination therapy between scaling-root planning (SRP) + laser + omega 3 gel in repeated time weekly for one month\].

Group IV

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with localized aggressive periodontitis.
• Patients must be medically free.
• Optimal compliance as evidenced by no missed treatment appointments and a positive attitude to maintain oral hygiene.
• Patients who are willing to participate in this study can enroll and complete it.

You may not qualify if:

• Patients with generalized aggressive periodontitis. Patients are over 35 years old.
• Pregnancy.
• Patients had scaling and root planning or antibiotic therapy in the last 6 months.
• Patients with hypersensitivity to fish oil.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist at ministry of health

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: May 8, 2022
• Primary Completion: April 21, 2024
• Study Completion: March 7, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)