Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

Sponsor

Manipal University College Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05927831

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dentin Hypersensitivity	Drug: Grape Seed Extract Device: Low-level laser therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Jan 15, 2024

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 Grape seed extract will be applied in the form of a gel on the tooth surface Other Names: GSE
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 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
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 Grape seed extract will be applied in the form of a gel on the tooth surface Other Names: GSE 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

Arm

Intervention/Treatment

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

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

Other Names:

GSE

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

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

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

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

Other Names:

GSE

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

Outcome Measures

Primary Outcome Measures

The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS) [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) [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) [7th day]
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manipal University College Malaysia	Melaka Tengah	Melaka	Malaysia	75450

Sponsors and Collaborators

Manipal University College Malaysia

Investigators

Principal Investigator: Tun Yi Darren Ong, Manipal University College Malaysia
Principal Investigator: Li Jia Ong, Manipal University College Malaysia
Principal Investigator: Ju Wen Lim, Manipal University College Malaysia
Principal Investigator: Wei Nee Lim, Manipal University College Malaysia
Principal Investigator: Gursimrendeep Kaur, Manipal University College Malaysia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Anchu Rachel Thomas, Associate Professor Dr., Manipal University College Malaysia

ClinicalTrials.gov Identifier:

NCT05927831

Other Study ID Numbers:

018/2023

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dentin Sensitivity

Hypersensitivity

Grape Seed Extract

Study Results

No Results Posted as of Jul 3, 2023