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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05927831
Other study ID # 018/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date January 15, 2024

Study information

Verified date June 2023
Source Manipal University College Malaysia
Contact Anchu R Thomas
Phone +601127292297
Email rachel.thomas@manipal.edu.my
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 15, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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: - 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.

Study Design


Intervention

Drug:
Grape Seed Extract
Grape seed extract will be applied in the form of a gel on the tooth surface
Device:
Low-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

Locations

Country Name City State
Malaysia Manipal University College Malaysia Melaka Tengah Melaka

Sponsors (1)

Lead Sponsor Collaborator
Manipal University College Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1st day
Primary 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. 3rd day
Primary 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. 7th day
See also
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