Efficacy of Laser Therapy for Periodontitis

Not Applicable

Not yet recruiting

• Conditions: Periodontal Disease

• Registration Number: NCT07013162
• Lead Sponsor: University of Science and Technology, Yemen

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.

Detailed Description

This study aims to compare the clinical and immunological effects of traditional mechanical debridement alone versus combined treatment with diode laser (high and low power). The clinical parameters include Plaque Index (PI), Gingival Index (GI), Periodontal Pocket Depth (PPD), and Clinical Attachment Loss (CAL). Immunological parameters include IL-1β, IL-6, IL-8, and TNF-α levels in GCF. Participants will be selected from the Yemeni population residing in Sana'a City. The study will include a control group receiving conventional therapy and two test groups receiving diode laser therapy with high and low intensity settings, respectively. Measurements will be recorded at baseline (T0), one month after treatment (T1), and three months post-treatment (T2).

The goal is to determine whether adjunctive diode laser therapy provides additional clinical and immunological benefits compared to conventional treatment alone.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-24
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Study Start: 2025-07-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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.

Exclusion Criteria

• 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. :

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in clinical periodontal parameters (Plaque Index)	Baseline,1 month, 3months after treatment	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
Change in clinical periodontal parameters (Gingival Index)	Baseline,1 month, 3months after treatment	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
Change in clinical periodontal parameters (Periodontal Pocket Depth)	Baseline,1 month, 3months after treatment	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
Change in clinical periodontal parameters (Clinical attachment level)	Baseline,1 month, 3months after treatment	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

Secondary Outcome Measures

Name	Time	Method
Change in interleukin-1B (IL-1B) levels in GCF	Baseline,1 month, 3months after treatment	Levels of interleukin-1 beta (IL-1β) in gingival crevicular fluid (GCF) will be measured at baseline, 1 month, and 3 months after treatment to assess immune response to periodontal therapy
Change in interleukin-6 (IL-6) levels in GCF	Baseline,1 month, 3months after treatment	Levels of interleukin-6 (IL-6) in gingival crevicular fluid (GCF) will be measured at baseline, 1 month, and 3 months after treatment to assess immune response to o assess immune response to periodontal therapy.
Change in interleukin-8 (IL-8) levels in GCF	Baseline,1 month, 3months after treatment	Levels of interleukin-8 (IL-8) in gingival crevicular fluid (GCF) will be measured at baseline, 1 month, and 3 months after treatment to assess immune response to o assess immune response to periodontal therapy.
Change in tumor necrosis factor-alpha (TNF-α) levels in GCF	Baseline,1 month, 3months after treatment	Levels of tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) will be measured at baseline, 1 month, and 3 months after treatment to assess immune response to o assess immune response to periodontal therapy.