The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy in Different Age Groups

November 20, 2023 updated by: Alaa Allah Hesham, Faculty of Dental Medicine for Girls

The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients (A Randomized Clinical Trial)

the summary is to evaluate The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

2 ml of unstimulated saliva will be collected using spitting method, the collected samples will then be analyzed using Elisa technique for salivary Inducible nitrous oxide synthase levels.

Study Type

Interventional

Enrollment (Estimated)

44

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt
    • Nasrcity Nasr Street
      • Cairo, Nasrcity Nasr Street, Egypt, 11765
        • Recruiting
        • Al-Azhar University
        • Contact:

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:

  • males and females
  • aged below 40 or above 60
  • periodontitis stage 2
  • no tooth loss due to periodontitis

Exclusion Criteria:

  • smoking habits
  • history of antibiotics
  • history of systemic diseases

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: old age group
old age group above 60 years old
Other: diode laser
low level diode therapy
Other: non surgical scaling
non surgical scaling using ultrasonic
Placebo Comparator: young aged group
young age group below 40 years old
Other: diode laser
low level diode therapy
Other: non surgical scaling
non surgical scaling using ultrasonic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical parameters (clinical attachment loss)
Time Frame: 6 months
measurement of clinical parameters clinical attachment loss in millimeters
6 months
clinical parameters (gingival index)
Time Frame: 6 months
measurement if the gingival index using scoring system. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of inducible nitrous oxide synthase levels
Time Frame: 3 months
measurement of inducible nitrous oxide synthase levels in different age groups before the procedure and after using Elisa kit.
3 months

Collaborators and Investigators

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

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Study Chair: Alaa H hesham mosa, bachelor's, Faculty of Dental Medicine for Girls
  • Principal Investigator: hamdy H nassar, Faculty of Dental Medicine for Girls
  • Study Director: amal AA ali, Faculty of Dental Medicine for Girls

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)

April 29, 2023

Primary Completion (Estimated)

April 29, 2024

Study Completion (Estimated)

June 29, 2024

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 20, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-ME-23-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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