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

Sponsor

Faculty of Dental Medicine for Girls (Other)

Overall Status

Recruiting

CT.gov ID

NCT06140394

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Periodontal Inflammation	Other: diode laser Other: non surgical scaling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Apr 29, 2023

Anticipated Primary Completion Date :

Apr 29, 2024

Anticipated Study Completion Date :

Jun 29, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

clinical parameters (gingival index) [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.
clinical parameters (clinical attachment loss) [6 months]
measurement of clinical parameters clinical attachment loss in millimeters

Secondary Outcome Measures

assessment of inducible nitrous oxide synthase levels [3 months]
measurement of inducible nitrous oxide synthase levels in different age groups before the procedure and after using Elisa kit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar University	Cairo	Nasrcity Nasr Street	Egypt	11765
2	Hamdy Nassar	Cairo		Egypt

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Allah Hesham, Bachelor's Degree (research assistant), Faculty of Dental Medicine for Girls

ClinicalTrials.gov Identifier:

NCT06140394

Other Study ID Numbers:

P-ME-23-04

First Posted:

Nov 20, 2023

Last Update Posted:

Nov 22, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Nov 22, 2023