Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Effectiveness of Grape Seed Extract (GSE) and Low-level Laser Therapy in the Management of Dentin Hypersensitivity: A Randomized Control Trial

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Drug: Grape Seed Extract
* Device: Low-level laser therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grape seed extract<br>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<br>* Grape seed extract will be applied in the form of a gel on the tooth surface<br>* Other names: GSE;|
| Experimental: Low-level laser therapy<br>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<br>* 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<br>|
| Experimental: Combination of low-level laser therapy and grape seed extract<br>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<br>* Grape seed extract will be applied in the form of a gel on the tooth surface<br>* Other names: GSE;Device: Low-level laser therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |