NCT06140394

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

November 12, 2023

Last Update Submit

June 27, 2024

Conditions

Periodontal Inflammation

Outcome Measures

Primary Outcomes (2)

  • clinical parameters (gingival index)

    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

  • clinical parameters (clinical attachment loss)

    measurement of clinical parameters clinical attachment loss in millimeters

    6 months

Secondary Outcomes (1)

  • assessment of inducible nitrous oxide synthase levels

    3 months

Study Arms (2)

old age group

ACTIVE COMPARATOR

old age group above 60 years old

Other: diode laserOther: non surgical scaling

young aged group

PLACEBO COMPARATOR

young age group below 40 years old

Other: diode laserOther: non surgical scaling

Interventions

diode laserOTHER

low level diode therapy

old age groupyoung aged group
non surgical scalingOTHER

non surgical scaling using ultrasonic

old age groupyoung aged group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Azhar University

Cairo, Nasrcity Nasr Street, 11765, Egypt

Location

Hamdy Nassar

Cairo, Egypt

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Alaa H hesham mosa, bachelor's

    Faculty of Dental Medicine for Girls

    STUDY CHAIR

  • hamdy H nassar

    Faculty of Dental Medicine for Girls

    PRINCIPAL INVESTIGATOR

  • amal AA ali

    Faculty of Dental Medicine for Girls

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor's Degree (research assistant)

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 20, 2023

Study Start

April 29, 2023

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations

EG(2)