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Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

Primary Purpose

Dentin Hypersensitivity

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Grape Seed Extract
Low-level laser therapy
Sponsored by
Manipal University College Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Manipal University College MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Grape seed extract

Low-level laser therapy

Combination of low-level laser therapy and grape seed extract

Arm Description

grape seed extract with 95% proanthocyanins will be applied topically to the hypersensitive dentin area for 10 minutes, followed by rinsing with water.

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.

Grape seed extract will be applied topically to the hypersensitive dentin area for 10 minutes, followed by low-level laser diode treatment.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2023
Last Updated
June 25, 2023
Sponsor
Manipal University College Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05927831
Brief Title
Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manipal University College Malaysia

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Grape seed extract
Arm Type
Experimental
Arm Description
grape seed extract with 95% proanthocyanins will be applied topically to the hypersensitive dentin area for 10 minutes, followed by rinsing with water.
Arm Title
Low-level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Combination of low-level laser therapy and grape seed extract
Arm Type
Experimental
Arm Description
Grape seed extract will be applied topically to the hypersensitive dentin area for 10 minutes, followed by low-level laser diode treatment.
Intervention Type
Drug
Intervention Name(s)
Grape Seed Extract
Other Intervention Name(s)
GSE
Intervention Description
Grape seed extract will be applied in the form of a gel on the tooth surface
Intervention Type
Device
Intervention Name(s)
Low-level laser therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
Description
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) before and after treatment.
Time Frame
1st day
Title
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
Description
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.
Time Frame
3rd day
Title
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
Description
The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)(0 to 10) after treatment.
Time Frame
7th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anchu R Thomas
Phone
+601127292297
Email
rachel.thomas@manipal.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tun Yi Darren Ong
Organizational Affiliation
Manipal University College Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Jia Ong
Organizational Affiliation
Manipal University College Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ju Wen Lim
Organizational Affiliation
Manipal University College Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Nee Lim
Organizational Affiliation
Manipal University College Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gursimrendeep Kaur
Organizational Affiliation
Manipal University College Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manipal University College Malaysia
City
Melaka Tengah
State/Province
Melaka
ZIP/Postal Code
75450
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anchu R Thomas
Phone
+601127292297
Email
rachel.thomas@manipal.edu.my

12. IPD Sharing Statement

Plan to Share IPD
No

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Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

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