- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06677385
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
Status
Completed
Conditions
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:
- Male or Female
- Aged below 40 or above 60.
- Provide informed consent and willingness to cooperate with study protocol.
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:
- Patients with heavy smoking habits
- History of antibiotics in the previous three months.
- Pregnant or lactating female.
- Treatment with any systemic drug.
- History of systemic disease.
- 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
Additional Relevant MeSH Terms
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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