Dentin HypersensitivityNCT05927831
Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity
A study testing Grape Seed Extract and Low-level laser therapy in people with Dentin Hypersensitivity, run by Manipal University College Malaysia at 1 site in Malaysia.
Trial summary
Dentin hypersensitivity (DH) is a common clinical problem frequently seen in dental patients. According to Splieth et al., the prevalence of dentin hypersensitivity is 3-98% in adult population.DH is described as a short, sharp pain or discomfort that responses to certain stimuli, typically thermal, tactile, osmotic… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Grape Seed Extract and Low-level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 May 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with at least three sensitive tooth by gingival recession or tooth wear >2 scores on the VAS scale.
- Tooth wear index score <3 (Smith and Knight tooth wear index)
- Systemically healthy patient.
- 20-50 years of age.
Who cannot join
- Teeth with caries, cracked teeth, mobile teeth and pulpitis.
- Deep periodontal pockets (probing depth >6 mm), periodontal surgery within the previous 3 months.
- Recent desensitizing therapy
- systemic diseases and gastric diseases (GERD)
- Allergy to active ingredients.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Manipal University College Malaysia
Melaka Tengah, Melaka, 75450
Anchu R Thomas, +601127292297, rachel.thomas@manipal.edu.my
About this study
Official title: Comparison of the Effectiveness of Grape Seed Extract (GSE) and Low-level Laser Therapy in the Management of Dentin Hypersensitivity: A Randomized Control Trial
Dentin hypersensitivity (DH) is a common clinical problem frequently seen in dental patients. According to Splieth et al., the prevalence of dentin hypersensitivity is 3-98% in adult population.DH is described as a short, sharp pain or discomfort that responses to certain stimuli, typically thermal, tactile, osmotic or chemical, due to exposed dentinal surface which can be explained by the hydrodynamic theory.
The laser is a narrow, focused beam of light emitted to vaporise, fuse, melt, or seal dentinal tubules using laser heat to induce hydroxyapatite crystals for recrystallisation of the mineral component of dentine. The obliteration of dentinal tubules is caused by heat generated by laser beam which inhibits the transmission of the stimulus in the dentinal tubules.
Grape seed extract contains proanthocyanidins (PA) which is able to bind to proline-rich proteins, like collagen, and contributes in enzyme proline hydroxylase activity that is essential for the biosynthesis of collagen in the dentin. The cross-linking action of collagen fibrils in dentin also able to prevent mineral loss.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Grape Seed Extract, Low-level laser therapy
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed ExtractDrug
Also called GSE
Grape seed extract will be applied in the form of a gel on the tooth surface
Low-level laser therapyDevice
The device will be set at a wavelength of 810 nm, with a power output of 0.5 watts tip of diameter 300 μ in non-contact mode
| Study group | Role | What they receive |
|---|---|---|
| Grape seed extract | Experimental | grape seed extract with 95% proanthocyanins will be applied topically to the hypersensitive dentin area for 10 minutes, followed by rinsing with water. Receives: Drug: Grape Seed Extract |
| Low-level laser therapy | Experimental | The low-level laser diode treatment of 810 nm will be performed using a commercially available diode laser device. The device will be set at a wavelength of 810 nm, with a power output of 0.5 watts tip of diameter 300 μ in non-contact mode starting at a distance of 5-6 mm away from the hypersensitive tooth area and slowly approaching within a distance of 2-3mm in a scanning motion covering the entire hypersensitive tooth area for a period of 30 seconds to 1 minute. Receives: Device: Low-level laser therapy |
| Combination of low-level laser therapy and grape seed extract | Experimental | Grape seed extract will be applied topically to the hypersensitive dentin area for 10 minutes, followed by low-level laser diode treatment. Receives: Drug: Grape Seed Extract; Device: Low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) before and after treatment.
Measured: 1st day
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.
Measured: 3rd day
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.
Measured: 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start15 May 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manipal University College Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anchu Rachel Thomas, Manipal University College Malaysia
- Investigators
- Tun Yi Darren Ong, Principal investigator, Manipal University College MalaysiaLi Jia Ong, Principal investigator, Manipal University College MalaysiaJu Wen Lim, Principal investigator, Manipal University College MalaysiaWei Nee Lim, Principal investigator, Manipal University College MalaysiaGursimrendeep Kaur, Principal investigator, Manipal University College Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927831
- Sponsor's protocol ID
- 018/2023
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ong TYD, Lim WN, Ong LJ, Lim JW, Kaur G, Thomas AR, Narasu VB. Comparison of the Effectiveness of Grape Seed Extract and Low-Level Laser Therapy in the Management of Dentin Hypersensitivity: A Randomized Controlled Trial. Scientifica (Cairo). 2026 Feb 12;2026:6656174. doi: 10.1155/sci5/6656174. eCollection 2026.
PubMed 41696662
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Grape Seed Extract (GSE) and Low-level Laser Therapy in the Management of Dentin Hypersensitivity: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05927831
- Acronym / sponsor ID
- 018/2023
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Manipal University College MalaysiaUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
Dentin hypersensitivity (DH) is a common clinical problem frequently seen in dental patients. According to Splieth et al., the prevalence of dentin hypersensitivity is 3-98% in adult population.DH is described as a short, sharp pain or discomfort that responses to certain stimuli, typically thermal, tactile, osmotic or chemical, due to exposed dentinal surface which can be explained by the hydrodynamic theory.
The laser is a narrow, focused beam of light emitted to vaporise, fuse, melt, or seal dentinal tubules using laser heat to induce hydroxyapatite crystals for recrystallisation of the mineral component of dentine. The obliteration of dentinal tubules is caused by heat generated by laser beam which inhibits the transmission of the stimulus in the dentinal tubules.
Grape seed extract contains proanthocyanidins (PA) which is able to bind to proline-rich proteins, like collagen, and contributes in enzyme proline hydroxylase activity that is essential for the biosynthesis of collagen in the dentin. The cross-linking action of collagen fibrils in dentin also able to prevent mineral loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grape seed extract | Experimental | Drug: Grape Seed Extractgrape seed extract with 95% proanthocyanins will be applied topically to the hypersensitive dentin area for 10 minutes, followed by rinsing with water. |
| Low-level laser therapy | Experimental | Device: Low-level laser therapyThe low-level laser diode treatment of 810 nm will be performed using a commercially available diode laser device. The device will be set at a wavelength of 810 nm, with a power output of 0.5 watts tip of diameter 300 μ in non-contact mode starting at a distance of 5-6 mm away from the hypersensitive tooth area and slowly approaching within a distance of 2-3mm in a scanning motion covering the entire hypersensitive tooth area for a period of 30 seconds to 1 minute. |
| Combination of low-level laser therapy and grape seed extract | Experimental | Drug: Grape Seed Extract, Device: Low-level laser therapyGrape seed extract will be applied topically to the hypersensitive dentin area for 10 minutes, followed by low-level laser diode treatment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with at least three sensitive tooth by gingival recession or tooth wear >2 scores on the VAS scale.
- Tooth wear index score <3 (Smith and Knight tooth wear index)
- Systemically healthy patient.
- 20-50 years of age.
Key exclusion criteria (5 listed)
- Teeth with caries, cracked teeth, mobile teeth and pulpitis.
- Deep periodontal pockets (probing depth >6 mm), periodontal surgery within the previous 3 months.
- Recent desensitizing therapy
- systemic diseases and gastric diseases (GERD)
- Allergy to active ingredients.
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 |
|---|---|---|
| Grape Seed ExtractAlso: GSEGrape seed extract will be applied in the form of a gel on the tooth surface | Drug | Combination of low-level laser therapy and grape seed extract, Grape seed extract |
| Low-level laser therapyThe device will be set at a wavelength of 810 nm, with a power output of 0.5 watts tip of diameter 300 μ in non-contact mode | Device | Combination of low-level laser therapy and grape seed extract, Low-level laser therapy |
Primary outcome
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
Time frame: 1st day
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) before and after treatment.
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
Time frame: 3rd day
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
Time frame: 7th day
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 41696662Ong TYD, Lim WN, Ong LJ, Lim JW, Kaur G, Thomas AR, Narasu VB. Comparison of the Effectiveness of Grape Seed Extract and Low-Level Laser Therapy in the Management of Dentin Hypersensitivity: A Randomized Controlled Trial. Scientifica (Cairo). 2026 Feb 12;2026:6656174. doi: 10.1155/sci5/6656174. eCollection 2026.
- Individual participant dataSharing planned: No
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Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study
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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. This study is not recruiting at the moment.
Tun Yi Darren Ong principal investigator
Manipal University College Malaysia
Li Jia Ong principal investigator
Manipal University College Malaysia
Ju Wen Lim principal investigator
Manipal University College Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape Seed Extract and Low-level laser therapy in people with Dentin Hypersensitivity, run by Manipal University College Malaysia at 1 site in Malaysia.
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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anchu R Thomas (+601127292297, rachel.thomas@manipal.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS) (time frame: 1st day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927831, which also lists 1 linked publication.
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 3 Jul 2023; AzTrials last refreshed its copy on 28 Oct 2026.