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Active, Not Recruiting

NCT Number: NCT07013162

Efficacy of Laser Therapy for Periodontitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

25 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Science and Technology Dental Clinic, Sanaa, Amanat Al Asimah, Yemen

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with generalized periodontitis (presence of bleeding on probing [BOP] and probing pocket depth [PPD] ≥ 4 mm)
  • Age between 25 and 58 years
  • Presence of at least 20 natural teeth present.

Exclusion criteria

  • Smokers or qat chewers
  • Pregnant or lactating women
  • Patients taking medications that may influence periodontal tissue status
  • Patients with systemic conditions affecting periodontal health
  • Patients who received periodontal therapy or antibiotic treatment within the last 3 months
  • Patients wearing intraoral appliances or having dental prostheses

Treatment and study plan

High power diode laser + SRT

Procedure

2W laser will be applied to periodontal pockets

Low diode diode laser + SRT

Procedure

A 0.5W low laser is applicated to periodontal pockets after mechanical debridement

Curettage (SRT) only

Procedure

Mechanical debridement for pocket

Primary outcomes

  1. Plaque Index (PI)

    Time frame: 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

  2. Gingival Index( GI)

    Time frame: 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

  3. Periodontal Pocket Depth (PPD)

    Time frame: 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

  4. Clinical attachment level (CAL)

    Time frame: 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 outcomes

  1. interleukin-6 (IL-6) levels in GCF

    Time frame: 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.

  2. interleukin-1B (IL-1B) levels in GCF

    Time frame: 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

  3. interleukin-8 (IL-8) levels in GCF

    Time frame: 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.

  4. tumor necrosis factor-alpha (TNF-α) levels in GCF

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Science and Technology, Yemen

Other

Registry information

Official study title

Efficacy of Diode Laser and Non-Surgical Periodontal Therapy in the Treatment of Periodontitis: A Clinical and Immunological Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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