Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Drug: Grape Seed Extract; Device: Low-level laser therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anchu R Thomas; Phone Number: +601127292297; Email: rachel.thomas@manipal.edu.my

Study Locations

• Malaysia
  • Melaka
    • Melaka Tengah, Melaka, Malaysia, 75450
      • Recruiting
      • Manipal University College Malaysia
      • Contact: Anchu R Thomas; Phone Number: +601127292297; Email: rachel.thomas@manipal.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): January 15, 2024

Study Registration Dates

• First Submitted: June 3, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Antioxidants; Grape Seed Extract
• Other Study ID Numbers: 018/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No