Clinical trial NCT07013162: Efficacy of Laser Therapy for Periodontitis
Official title: Efficacy of Diode Laser and Non-Surgical Periodontal Therapy in the Treatment of Periodontitis: A Clinical and Immunological Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontal Disease
Keywords: Periodontal disease
Diode laser
Non-surgical periodontal therapy
Gingival crevicular fluid
IL-1B
IL-6
IL-8
TNF
Laser dentistry
Periodontitis
Yemen
Lead sponsor: University of Science and Technology, Yemen
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a three-arm parallel assignment study comparing the effects of different periodontal treatments in patients with periodontitis. Participants were randomly assigned to one of the following groups: (1) scaling and root planing (SRP) alone, (2) SRP combined with high-power diode laser, or (3) SRP combined with low-power diode laser. The study aimed to evaluate changes in clinical periodontal parameters and inflammatory cytokine levels in gingival crevicular fluid at baseline, 1 month, and 3 months after treatment.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. :

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Primary outcomes:
measure: Change in clinical periodontal parameters (Plaque Index)
timeFrame: Baseline,1 month, 3months after treatment
measure: Change in clinical periodontal parameters (Gingival Index)
timeFrame: Baseline,1 month, 3months after treatment
measure: Change in clinical periodontal parameters (Periodontal Pocket Depth)
timeFrame: Baseline,1 month, 3months after treatment
measure: Change in clinical periodontal parameters (Clinical attachment level)
timeFrame: Baseline,1 month, 3months after treatment
Secondary outcomes:
measure: Change in interleukin-6 (IL-6) levels in GCF
timeFrame: Baseline,1 month, 3months after treatment
measure: Change in interleukin-1B (IL-1B) levels in GCF
timeFrame: Baseline,1 month, 3months after treatment
measure: Change in interleukin-8 (IL-8) levels in GCF
timeFrame: Baseline,1 month, 3months after treatment
measure: Change in tumor necrosis factor-alpha (TNF-α) levels in GCF
timeFrame: Baseline,1 month, 3months after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of dentistry -Thamar university
name: Waddah N Al-Hajj, Assoc prof
role: STUDY_CHAIR
References: