Effect of Low-Level Laser on Crevicular Interleukin-1β Concentration in Patients with Periodontal Disease: a Relation to Periodontal Inflammaging

February 24, 2025 updated by: Asmaa EssamEldin Ahmed, Misr University for Science and Technology
This study is done to compare between young age and old age patients with periodontitis (inflammaging) and the effect of diode laser as adjunctive to scaling and debridement

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

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

      • Giza, Egypt, 0000
        • Misr University foe Science and Technology

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or Female
  2. Aged below 40 or above 60.
  3. Provide informed consent and willingness to cooperate with study protocol.
  4. Periodontitis stage II patients:

    • CAL from 3-4 mm.
    • Radiographic bone loss (15% to 33%).
    • No tooth loss due to periodontitis.
    • Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

Exclusion Criteria:

  1. Patients with heavy smoking habits
  2. History of antibiotics in the previous three months.
  3. Pregnant or lactating female.
  4. Treatment with any systemic drug.
  5. History of systemic disease.
  6. Patients who received periodontal treatment in the last 6 months

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional scaling and debridement in young aged patients
scaling and debridement
conventional scaling and debridement
Experimental: Conventional scaling and debridement of old aged patients
conventional scaling and debridement
Experimental: diode laser as adjunctive to conventional scaling and debridement for old age patients
diode laser as adjunctive to conventional scaling and debridement for old age patients
Experimental: diode laser as adjunctive to conventional scaling and debridement for young age patients
diode laser as adjunctive to conventional scaling and debridement for old age patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival index
Time Frame: first visit, second follow up after 1 month and final follow up after 6 months
first visit, second follow up after 1 month and final follow up after 6 months
Clinical attachment loss
Time Frame: first visit, second follow up after 1 month and final follow up after 6 months
first visit, second follow up after 1 month and final follow up after 6 months
Interleukin 1 beta
Time Frame: first visit, second follow up after 1 month and final follow up after 6 months
collected and analyzed by ELISA from Gingival crevicular fluid and blood serum
first visit, second follow up after 1 month and final follow up after 6 months

Collaborators and Investigators

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

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)

July 12, 2023

Primary Completion (Actual)

March 12, 2024

Study Completion (Actual)

October 12, 2024

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022/0082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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