Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

Dentin Hypersensitivity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927831
• Other study ID #: 018/2023
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

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