Efficacy of Laser Therapy for Periodontitis

NCT07013162 | Active Not Recruiting DMC

• 1 other identifier: DLT-UST-YEMEN
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• interleukin-6 (IL-6) levels in GCF

  Baseline,1 month, 3months after treatment

• interleukin-1B (IL-1B) levels in GCF

  Baseline,1 month, 3months after treatment

• interleukin-8 (IL-8) levels in GCF

  Baseline,1 month, 3months after treatment

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

  Baseline,1 month, 3months after treatment

Study Arms (3)

scaling and root planning (SRP)

ACTIVE COMPARATOR

Patients receive only subgingival curettage by curettes and ultrasonic scaler

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

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

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

Interventions

High power diode laser + SRT PROCEDURE

2W laser will be applied to periodontal pockets

High Diode Laser (H D Laser)

Low diode diode laser + SRT PROCEDURE

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

Low Diode Laser (L D Laser)

Curettage (SRT) only PROCEDURE

Mechanical debridement for pocket

High Diode Laser (H D Laser); Low Diode Laser (L D Laser); scaling and root planning (SRP)

Eligibility Criteria

• Age: 25 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Science and Technology, Yemen: lead

Study Sites (2)

University of Science and Technology Dental Clinic

Sanaa, Amanat Al Asimah, Yemen

Location

University of Science and Technology Dental Clinic

Sanaa, Yemen

Location

Related Links

• University of Science and Technology - Yemen official site

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Interventions

Curettage; Single Person

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Waddah N Al-Hajj, Assoc prof

  Faculty of dentistry -Thamar university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer and principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: August 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

YE (2)