Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity

NCT06759454 | Not Yet Recruiting FDA Device

• 1 other identifier: 208-ERB/024
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of laser therapy versus desensitizing agents in reducing pain among participants with dentinal hypersensitivity conducted in Saidu College of Dentistry. Pain will be measured at baseline, immediately post-treatment, one week, and three months using the Visual Analog Scale (VAS)

Conditions

Dentinal Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity: Visual Analog Scale

  After intervention there is a possibility of change in pain intensity in Dentinal Hypersensitivity

  Immediately post-treatment, one week, and three months

Study Arms (2)

Arm 1 (Desensitizing Agent)

ACTIVE COMPARATOR

A glutaraldehyde-based desensitizing agent applied to affected teeth for 30 seconds, air-dried, with post-application instructions

Drug: Glutaraldehyde-Based Desensetizing Agent

Arm 2 (Laser Therapy)

EXPERIMENTAL

Diode laser set to 100 mW in continuous wave mode, applied to specific areas of affected teeth for three minutes

Device: Low Level Laser Therapy

Interventions

Glutaraldehyde-Based Desensetizing Agent DRUG

A glutaraldehyde-based desensitizing agent applied to the cervical area of affected teeth using a micro-brush, left undisturbed for 30 seconds, and air-dried. Both interventions aim to reduce pain associated with dentinal hypersensitivity by either occluding dentinal tubules or reducing nerve excitability

Arm 1 (Desensitizing Agent)

Low Level Laser Therapy DEVICE

Low-level laser therapy (LLLT) using a diode laser set to a low power level (e.g., 100 mW, continuous wave mode). Each affected tooth will be treated for three minutes, targeting apical, cervical, and middle points

Arm 2 (Laser Therapy)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18-50 years with a preoperative VAS score of ≥2 for dentinal hypersensitivity.
• Participants with sensitivity due to gingival recession, cervical abrasion, or enamel erosion.
• Participants with good systemic health.
• Minimum of two hypersensitive teeth present in two different quadrants.

You may not qualify if:

• Teeth with caries, defective restorations, or cervical defects \> 2 mm (may affect sensitivity measurements).
• Periodontal surgery or deep periodontal pockets (\> 6 mm) within the past three months (potential influence on periodontal health and sensitivity).
• Participants using desensitizing toothpaste within the past three months (could interfere with study outcomes).
• Presence of gross oral pathology or systemic diseases (e.g., eating disorders, chronic diseases, uncontrolled metabolic conditions) (may alter oral health status).
• Pregnant or lactating women (hormonal changes can influence oral health).

Sponsors & Collaborators

• Kemia Gul: lead

Study Sites (1)

Saidu College of Dentistry

Swat, KPK, Pakistan

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• BREKHNA YOUSAFZAI

  Saidu College of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brekhna Yousafzai

CONTACT

+923417262127; kemiagul3456@gmail.com

Kemia Gul

CONTACT

+923352803890; brekhna.apple123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Comparison of Mean Pain Score Using Laser Therapy and Desensitizing Agents in Patients with Dentinal Hypersensitivity: A Randomized Controlled Trial

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: June 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)