- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06759454
Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
May 7, 2025 updated by: Kemia Gul
Comparison of Mean Pain Score Using LASER Therapy and Desensitizing Agents in Patients With Dentinal Hypersensitivity: A Randomized Controlled Trial
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)
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study examines dentinal hypersensitivity treatment modalities, including laser therapy and desensitizing agents.
The study is conducted in compliance with regional ethical guidelines
Study Type
Interventional
Enrollment (Estimated)
172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brekhna Yousafzai
- Phone Number: +923417262127
- Email: kemiagul3456@gmail.com
Study Contact Backup
- Name: Kemia Gul
- Phone Number: +923352803890
- Email: brekhna.apple123@gmail.com
Study Locations
-
-
KPK
-
Swat, KPK, Pakistan
- Saidu College of Dentistry
-
Principal Investigator:
- BREKHNA YOUSAFZAI
-
Sub-Investigator:
- KEMIA GUL
-
Sub-Investigator:
- FAYYAZ ALAM
-
Contact:
- Saidu College of Dentistry Saidu Sharif Swat
- Phone Number: 009469240142
- Email: info.scdswat@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1 (Desensitizing Agent)
A glutaraldehyde-based desensitizing agent applied to affected teeth for 30 seconds, air-dried, with post-application instructions
|
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
|
|
Experimental: Arm 2 (Laser Therapy)
Diode laser set to 100 mW in continuous wave mode, applied to specific areas of affected teeth for three minutes
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity: Visual Analog Scale
Time Frame: Immediately post-treatment, one week, and three months
|
After intervention there is a possibility of change in pain intensity in Dentinal Hypersensitivity
|
Immediately post-treatment, one week, and three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: BREKHNA YOUSAFZAI, Saidu College of Dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 30, 2025
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
December 28, 2024
First Submitted That Met QC Criteria
January 3, 2025
First Posted (Actual)
January 6, 2025
Study Record Updates
Last Update Posted (Actual)
May 11, 2025
Last Update Submitted That Met QC Criteria
May 7, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 208-ERB/024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared with other researchers due to confidentiality concerns, ethical considerations, and the absence of any formal plan for data sharing at this time
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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