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RecruitingNCT05927831Updated Jul 3, 2023

Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

An interventional study of Grape Seed Extract and Low-level laser therapy in Dentin Hypersensitivity, sponsored by Manipal University College Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by Manipal University College Malaysia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dentin Hypersensitivity

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03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Manipal University College Malaysia is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Grape seed extract

    grape seed extract with 95% proanthocyanins will be applied topically to the hypersensitive dentin area for 10 minutes, followed by rinsing with water.

    Drug: Grape Seed Extract

  • Experimental
    Low-level laser therapy

    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.

    Device: Low-level laser therapy

  • Experimental
    Combination of low-level laser therapy and grape seed extract

    Grape seed extract will be applied topically to the hypersensitive dentin area for 10 minutes, followed by low-level laser diode treatment.

    Drug: Grape Seed Extract · Device: Low-level laser therapy

Interventions

  • Grape seed extract will be applied in the form of a gel on the tooth surface

    Also known as: GSE

  • DeviceLow-level laser therapy

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1st day

  2. 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.

    Time frame: 3rd day

  3. 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.

    Time frame: 7th day

07

Study locations

1 of 1 sites recruiting
  • Manipal University College Malaysia
    Melaka Tengah, Melaka 75450, Malaysia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05927831
Lead sponsor
Manipal University College Malaysia
Responsible party
Dr. Anchu Rachel Thomas (Associate Professor Dr., Manipal University College Malaysia) — Principal investigator
First posted
Jul 3, 2023
Start date
May 15, 2023
Primary completion
Jan 15, 2024 (estimated)
Completion
Jan 15, 2024 (estimated)
Last update
Jul 3, 2023

Study contacts

Anchu R Thomas
Contact
rachel.thomas@manipal.edu.my
+601127292297
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
Wei Nee Lim
principal investigator · Manipal University College Malaysia
Gursimrendeep Kaur
principal investigator · Manipal University College Malaysia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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