NCT07013162

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

May 24, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 24, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

Periodontal diseaseDiode laserNon-surgical periodontal therapyGingival crevicular fluidIL-1BIL-6IL-8TNFLaser dentistryPeriodontitisYemen

Outcome Measures

Primary Outcomes (4)

  • Change in clinical periodontal parameters (Plaque Index)

    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

  • Change in clinical periodontal parameters (Gingival Index)

    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

  • Change in clinical periodontal parameters (Periodontal Pocket Depth)

    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

  • Change in clinical periodontal parameters (Clinical attachment level)

    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)

  • Change in interleukin-6 (IL-6) levels in GCF

    Baseline,1 month, 3months after treatment

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

    Baseline,1 month, 3months after treatment

  • Change in interleukin-8 (IL-8) levels in GCF

    Baseline,1 month, 3months after treatment

  • Change in 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 + SRTProcedure: 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 + SRTProcedure: Curettage (SRT) only

Interventions

2W laser will be applied to periodontal pockets

High Diode Laser (H D Laser)

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

Low Diode Laser (L D Laser)

Mechanical debridement for pocket

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

Eligibility Criteria

Age25 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Only patients meeting the following criteria will be enrolled into the study:
  • Patient with generalized periodontitis (BOP and PPD ≥ 4 mm).
  • Age group of 25-58 years old of periodontitis patients with at least 20 teeth present.

You may not qualify if:

  • Smoker and qat chewer patients.
  • Pregnant and lactating women.
  • Patients take medications which might influence the periodontal tissue state.
  • Patients having systemic health disorders which affect the periodontium by history.
  • Patients who received periodontal treatment or antibiotic therapy 3 months before the study.
  • VI. Patient wearing intra-oral appliance or with dental prosthesis. :

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

CurettageSingle Person

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Waddah N Al-Hajj, Assoc prof

    Faculty of dentistry -Thamar university

    STUDY CHAIR

Central Study Contacts

Amani A AL-Sharani, BDS, MSc

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 24, 2025

First Posted

June 10, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 10, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

"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."

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
More information

Available IPD Datasets

Study Protocol Access