Dentinal HypersensitivityNCT06759454
Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
A study testing Glutaraldehyde-Based Desensetizing Agent and Low Level Laser Therapy in people with Dentinal Hypersensitivity, run by Kemia Gul at 1 site in Pakistan.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- Glutaraldehyde-Based Desensetizing Agent and Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Saidu College of Dentistry
Swat, KPK
Saidu College of Dentistry Saidu Sharif Swat, 009469240142, info.scdswat@gmail.com
BREKHNA YOUSAFZAI
About this study
Official title: 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)
Read the 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
- Conditions
- Dentinal Hypersensitivity
- Being tested
- Glutaraldehyde-Based Desensetizing Agent, Low Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutaraldehyde-Based Desensetizing AgentDrug
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
Low Level Laser TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Desensitizing Agent) | Active comparator | A glutaraldehyde-based desensitizing agent applied to affected teeth for 30 seconds, air-dried, with post-application instructions Receives: 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 Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity: Visual Analog Scale
After intervention there is a possibility of change in pain intensity in Dentinal Hypersensitivity
Measured: Immediately post-treatment, one week, and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kemia Gul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kemia Gul, College of Physicians and Surgeons Pakistan
- Investigators
- BREKHNA YOUSAFZAI, Principal investigator, Saidu College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759454
- Sponsor's protocol ID
- 208-ERB/024
- Status last verified
- May 2025
- First submitted
- 28 Dec 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Pain Score Using LASER Therapy and Desensitizing Agents in Patients With Dentinal Hypersensitivity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06759454
- Acronym / sponsor ID
- 208-ERB/024
- Conditions
- Dentinal Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Kemia GulUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Desensitizing Agent) | Active comparator | Drug: Glutaraldehyde-Based Desensetizing AgentA glutaraldehyde-based desensitizing agent applied to affected teeth for 30 seconds, air-dried, with post-application instructions |
| Arm 2 (Laser Therapy) | Experimental | Device: Low Level Laser TherapyDiode laser set to 100 mW in continuous wave mode, applied to specific areas of affected teeth for three minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutaraldehyde-Based Desensetizing AgentA 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 | Drug | Arm 1 (Desensitizing Agent) |
| Low Level Laser TherapyLow-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 | Device | Arm 2 (Laser Therapy) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BREKHNA YOUSAFZAI principal investigator
Saidu College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutaraldehyde-Based Desensetizing Agent and Low Level Laser Therapy in people with Dentinal Hypersensitivity, run by Kemia Gul at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brekhna Yousafzai (+923417262127, kemiagul3456@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity: Visual Analog Scale (time frame: Immediately post-treatment, one week, and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.