Periodontal DiseaseNCT07013162
Efficacy of Laser Therapy for Periodontitis
A study testing High power diode laser + SRT, Low diode diode laser + SRT and Curettage (SRT) only in people with Periodontal Disease, run by University of Science and Technology, Yemen at 2 sites in Yemen.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- High power diode laser + SRT, Low diode diode laser + SRT and Curettage (SRT) only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesYemen
- Study dates
- 1 Jul 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Yemen2 sites
University of Science and Technology Dental Clinic
Sanaa, Amanat Al Asimah
University of Science and Technology Dental Clinic
Sanaa
About this study
Official title: Efficacy of Diode Laser and Non-Surgical Periodontal Therapy in the Treatment of Periodontitis: A Clinical and Immunological Study
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.
- Conditions
- Periodontal Disease
- Being tested
- High power diode laser + SRT, Low diode diode laser + SRT, Curettage (SRT) only
- Keywords
- Periodontal disease, Diode laser, Non-surgical periodontal therapy, Gingival crevicular fluid, IL-1B, IL-6, IL-8, TNF, Laser dentistry, Periodontitis, Yemen
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High power diode laser + SRTProcedure or surgery
2W laser will be applied to periodontal pockets
Low diode diode laser + SRTProcedure or surgery
A 0.5W low laser is applicated to periodontal pockets after mechanical debridement
Curettage (SRT) onlyProcedure or surgery
Mechanical debridement for pocket
| Study group | Role | What they receive |
|---|---|---|
| scaling and root planning (SRP) | Active comparator | Patients receive only subgingival curettage by curettes and ultrasonic scaler Receives: Procedure: Curettage (SRT) only |
| High Diode Laser (H D Laser) | Experimental | Patients recieved high power diode laser (2W) after curettage to pocket disinfection and tissue healing Receives: Procedure: High power diode laser + SRT; Procedure: Curettage (SRT) only |
| Low Diode Laser (L D Laser) | Experimental | Low power laser(0. 5W) is applicated to patient after curettage Receives: Procedure: Low diode diode laser + SRT; Procedure: Curettage (SRT) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline,1 month, 3months after treatment
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
Measured: Baseline,1 month, 3months after treatment
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
Measured: Baseline,1 month, 3months after treatment
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
Measured: Baseline,1 month, 3months after treatment
Secondary outcomes (4)
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.
Measured: Baseline,1 month, 3months after treatment
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
Measured: Baseline,1 month, 3months after treatment
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.
Measured: Baseline,1 month, 3months after treatment
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.
Measured: Baseline,1 month, 3months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Science and Technology, Yemen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Abdulhakeem Alsharani, University of Science and Technology, Yemen
- Investigators
- Waddah N Al-Hajj, Assoc prof, Study chair, Faculty of dentistry -Thamar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013162
- Sponsor's protocol ID
- DLT-UST-YEMEN
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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."
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diode Laser and Non-Surgical Periodontal Therapy in the Treatment of Periodontitis: A Clinical and Immunological Study
- ClinicalTrials.gov ID
- NCT07013162
- Acronym / sponsor ID
- DLT-UST-YEMEN
- Conditions
- Periodontal Disease
- Keywords
- Periodontal disease, Diode laser, Non-surgical periodontal therapy, Gingival crevicular fluid, IL-1B, IL-6, IL-8, TNF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of Science and Technology, YemenUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| scaling and root planning (SRP) | Active comparator | Procedure: Curettage (SRT) onlyPatients receive only subgingival curettage by curettes and ultrasonic scaler |
| High Diode Laser (H D Laser) | Experimental | Procedure: High power diode laser + SRT, Procedure: Curettage (SRT) onlyPatients recieved high power diode laser (2W) after curettage to pocket disinfection and tissue healing |
| Low Diode Laser (L D Laser) | Experimental | Procedure: Low diode diode laser + SRT, Procedure: Curettage (SRT) onlyLow power laser(0. 5W) is applicated to patient after curettage |
Who may qualify
- Ages
- 25 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High power diode laser + SRT2W laser will be applied to periodontal pockets | Procedure or surgery | High Diode Laser (H D Laser) |
| Low diode diode laser + SRTA 0.5W low laser is applicated to periodontal pockets after mechanical debridement | Procedure or surgery | Low Diode Laser (L D Laser) |
| Curettage (SRT) onlyMechanical debridement for pocket | Procedure or surgery | High Diode Laser (H D Laser), Low Diode Laser (L D Laser), scaling and root planning (SRP) |
Primary outcome
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
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
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
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
4 secondary outcomes
interleukin-6 (IL-6) levels in GCF
Time frame: Baseline,1 month, 3months after treatment
interleukin-1B (IL-1B) levels in GCF
Time frame: Baseline,1 month, 3months after treatment
interleukin-8 (IL-8) levels in GCF
Time frame: Baseline,1 month, 3months after treatment
tumor necrosis factor-alpha (TNF-α) levels in GCF
Time frame: Baseline,1 month, 3months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 41723233Al-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.
- University of Science and Technology - Yemen official siteLink provided by the sponsor.
- Individual participant dataSharing planned: 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."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waddah N Al-Hajj, Assoc prof study chair
Faculty of dentistry -Thamar university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High power diode laser + SRT, Low diode diode laser + SRT and Curettage (SRT) only in people with Periodontal Disease, run by University of Science and Technology, Yemen at 2 sites in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (PI) (time frame: Baseline,1 month, 3months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.