Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scaling and root planning (SRP) | Active Comparator | Patients receive only subgingival curettage by curettes and ultrasonic scaler |
|
| High Diode Laser (H D Laser) | Experimental | Patients recieved high power diode laser (2W) after curettage to pocket disinfection and tissue healing |
|
| Low Diode Laser (L D Laser) | Experimental | Low power laser(0. 5W) is applicated to patient after curettage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High power diode laser + SRT | Procedure | 2W laser will be applied to periodontal pockets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | Baseline,1 month, 3months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline,1 month, 3months after treatment |
| interleukin-1B (IL-1B) levels in GCF |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Waddah N Al-Hajj, Assoc prof | Faculty of dentistry -Thamar university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Science and Technology Dental Clinic | Sanaa | Amanat Al Asimah | Yemen | |||
| University of Science and Technology Dental Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41723233 | Derived | 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. |
| Label | URL |
|---|---|
| University of Science and Technology - Yemen official site | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
"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."
Starting 6 months after publication, available for 5 years
Data will be shared upon reasonable request to the corresponding author via email
Not provided
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003475 | Curettage |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| 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 |
|
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 |
| 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. | 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. | Baseline,1 month, 3months after treatment |
| Sanaa |
| Yemen |
De-identified data including patient demographics, treatment allocation (scaling only, scaling + high-power diode laser, scaling + low-power diode laser), changes in periodontal pocket depth, and levels of cytokines (IL-1β, IL-6, IL-8, TNF-α) will be made available. Data access will be granted upon reasonable request submitted to the corresponding author via email at: aamanialsharani.aa@gmail.com. |
| D011154 |
| Population Characteristics |
| D012959 | Socioeconomic Factors |