Efficacy of Laser Therapy for Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-08-01

Brief Summary

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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.

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Detailed Description

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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

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Periodontal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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scaling and root planning (SRP)

Patients receive only subgingival curettage by curettes and ultrasonic scaler

Group Type ACTIVE_COMPARATOR

Curettage (SRT) only

Intervention Type PROCEDURE

Mechanical debridement for pocket

High Diode Laser (H D Laser)

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

Group Type EXPERIMENTAL

High power diode laser + SRT

Intervention Type PROCEDURE

2W laser will be applied to periodontal pockets

Curettage (SRT) only

Intervention Type PROCEDURE

Mechanical debridement for pocket

Low Diode Laser (L D Laser)

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

Group Type EXPERIMENTAL

Low diode diode laser + SRT

Intervention Type PROCEDURE

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

Curettage (SRT) only

Intervention Type PROCEDURE

Mechanical debridement for pocket

Interventions

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High power diode laser + SRT

2W laser will be applied to periodontal pockets

Intervention Type PROCEDURE

Low diode diode laser + SRT

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

Intervention Type PROCEDURE

Curettage (SRT) only

Mechanical debridement for pocket

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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. :

\-

Minimum Eligible Age

25 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Amani Abdulhakeem Alsharani

Assistant Lecturer and principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waddah N Al-Hajj, Assoc prof

Role: STUDY_CHAIR

Faculty of dentistry -Thamar university

Central Contacts

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Amani A AL-Sharani, BDS, MSc

Role: CONTACT

[email protected]

00967779410066

Study Documents

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Document Type: Study Protocol

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: [email protected].

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