Efficacy of Laser Therapy for Periodontitis
Efficacy of Diode Laser and Non-Surgical Periodontal Therapy in the Treatment of Periodontitis: A Clinical and Immunological Study
1 other identifier
interventional
21
0 countries
N/A
Brief Summary
The aim of this study is to evaluate the efficacy of diode laser in addition to periodontal treatment in periodontitis patients and to investigate their effects on gingival crevicular fluid (GCF) cytokine levels before and after treatment, among some Yemeni individuals in Sana'a city.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
June 10, 2025
May 1, 2025
11 months
May 24, 2025
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in clinical periodontal parameters (Plaque Index)
Clinical evaluation of plaque index will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
Baseline,1 month, 3months after treatment
Change in clinical periodontal parameters (Gingival Index)
Clinical evaluation of gingival index will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
Baseline,1 month, 3months after treatment
Change in clinical periodontal parameters (Periodontal Pocket Depth)
Clinical evaluation of periodontal pocket depth will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
Baseline,1 month, 3months after treatment
Change in clinical periodontal parameters (Clinical attachment level)
Clinical evaluation of clinical attachment level will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
Baseline,1 month, 3months after treatment
Secondary Outcomes (4)
Change in interleukin-6 (IL-6) levels in GCF
Baseline,1 month, 3months after treatment
Change in interleukin-1B (IL-1B) levels in GCF
Baseline,1 month, 3months after treatment
Change in interleukin-8 (IL-8) levels in GCF
Baseline,1 month, 3months after treatment
Change in tumor necrosis factor-alpha (TNF-α) levels in GCF
Baseline,1 month, 3months after treatment
Study Arms (3)
scaling and root planning (SRP)
ACTIVE COMPARATORPatients receive only subgingival curettage by curettes and ultrasonic scaler
High Diode Laser (H D Laser)
EXPERIMENTALPatients recieved high power diode laser (2W) after curettage to pocket disinfection and tissue healing
Low Diode Laser (L D Laser)
EXPERIMENTALLow power laser(0. 5W) is applicated to patient after curettage
Interventions
2W laser will be applied to periodontal pockets
A 0.5W low laser is applicated to periodontal pockets after mechanical debridement
Mechanical debridement for pocket
Eligibility Criteria
You may qualify if:
- Only patients meeting the following criteria will be enrolled into the study:
- Patient with generalized periodontitis (BOP and PPD ≥ 4 mm).
- Age group of 25-58 years old of periodontitis patients with at least 20 teeth present.
You may not qualify if:
- Smoker and qat chewer patients.
- Pregnant and lactating women.
- Patients take medications which might influence the periodontal tissue state.
- Patients having systemic health disorders which affect the periodontium by history.
- Patients who received periodontal treatment or antibiotic therapy 3 months before the study.
- VI. Patient wearing intra-oral appliance or with dental prosthesis. :
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Waddah N Al-Hajj, Assoc prof
Faculty of dentistry -Thamar university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer and principal investigator
Study Record Dates
First Submitted
May 24, 2025
First Posted
June 10, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
June 10, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Starting 6 months after publication, available for 5 years
- Access Criteria
- Data will be shared upon reasonable request to the corresponding author via email
"De-identified individual participant data (IPD) including demographic information, treatment assignment, clinical outcomes, and cytokine levels will be shared. The data will be made available to qualified researchers for non-commercial academic use after publication of the primary results."