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Active, not recruitingNCT07013162Updated May 7, 2026

Efficacy of Laser Therapy for Periodontitis

An interventional study of High power diode laser + SRT and Low diode diode laser + SRT in Periodontal Disease, sponsored by University of Science and Technology, Yemen. Active, not recruiting at 2 sites in Yemen. Open to participants aged 25 Years to 58 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.

Primary conditionPeriodontitisRegistry: Periodontal DiseasesReclassifiedWhy we changed it
Registry
Periodontal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Periodontitis
Why
  1. The study's title name Periodontitis, a narrower term within Periodontal Diseases.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Science and Technology, Yemen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
25 Years to 58 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontal Disease

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Keywords

  • Periodontal disease
  • Diode laser
  • Non-surgical periodontal therapy
  • Gingival crevicular fluid
  • IL-1B
  • IL-6
  • IL-8
  • TNF
  • Laser dentistry
  • Periodontitis
  • Yemen
03

In context

Periodontitis Reclassified

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's planned enrollment of 21 is below the median of 44 across 846 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Science and Technology, Yemen is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Compared within Periodontitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
25 Years to 58 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Smokers or qat chewers
  2. Pregnant or lactating women
  3. Patients taking medications that may influence periodontal tissue status
  4. Patients with systemic conditions affecting periodontal health
  5. Patients who received periodontal therapy or antibiotic treatment within the last 3 months
  6. Patients wearing intraoral appliances or having dental prostheses
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
21 participants (estimated)

Study arms

  • Active comparator
    scaling and root planning (SRP)

    Patients receive only subgingival curettage by curettes and ultrasonic scaler

    Procedure: Curettage (SRT) only

  • Experimental
    High Diode Laser (H D Laser)

    Patients recieved high power diode laser (2W) after curettage to pocket disinfection and tissue healing

    Procedure: High power diode laser + SRT · Procedure: Curettage (SRT) only

  • Experimental
    Low Diode Laser (L D Laser)

    Low power laser(0. 5W) is applicated to patient after curettage

    Procedure: Low diode diode laser + SRT · Procedure: Curettage (SRT) only

Interventions

  • ProcedureHigh power diode laser + SRT

    2W laser will be applied to periodontal pockets

  • ProcedureLow diode diode laser + SRT

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

  • ProcedureCurettage (SRT) only

    Mechanical debridement for pocket

06

What researchers measure

Primary outcomes

  1. Plaque Index (PI)

    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

    Time frame: Baseline,1 month, 3months after treatment

  2. Gingival Index( GI)

    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

    Time frame: Baseline,1 month, 3months after treatment

  3. Periodontal Pocket Depth (PPD)

    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

    Time frame: Baseline,1 month, 3months after treatment

  4. Clinical attachment level (CAL)

    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

    Time frame: Baseline,1 month, 3months after treatment

Secondary outcomes

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

    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.

    Time frame: Baseline,1 month, 3months after treatment

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

    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

    Time frame: Baseline,1 month, 3months after treatment

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

    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.

    Time frame: Baseline,1 month, 3months after treatment

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

    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.

    Time frame: Baseline,1 month, 3months after treatment

07

Study locations

2 sites
  • University of Science and Technology Dental Clinic
    Sanaa, Amanat Al Asimah, Yemen
  • University of Science and Technology Dental Clinic
    Sanaa, Yemen
08

References and documents

Publications

  • Al-Sharani AA, Al-Hajj WA, Madfa AA. Clinical efficacy of high versus low intensity diode laser as an adjunct to non-surgical periodontal therapy in periodontitis: randomized controlled clinical trial. Sci Rep. 2026 Feb 21;16(1):10100. doi: 10.1038/s41598-026-40879-8. PubMed 41723233 ↗

Individual participant data

Plan to share: Yes — "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."

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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

Data sharing details ↗ · www.ust.edu.ye

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.

Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 11 months is below that.

Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2025
First posted
Jun 10, 2025
StartActual
Jul 1, 2025
Primary completionEst.
Jun 1, 2026
CompletionEst.
Aug 1, 2026
Last update
May 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07013162
Lead sponsor
University of Science and Technology, Yemen
Responsible party
Amani Abdulhakeem Alsharani (Assistant Lecturer and principal investigator, University of Science and Technology, Yemen) — Principal investigator
First posted
Jun 10, 2025
Start date
Jul 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
May 7, 2026

Study contacts

Waddah N Al-Hajj, Assoc prof
study chair · Faculty of dentistry -Thamar university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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