Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

NCT05927831 | Unknown

• 1 other identifier: 018/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Grape seed extract

EXPERIMENTAL

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

Low-level laser therapy

EXPERIMENTAL

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

Combination of low-level laser therapy and grape seed extract

EXPERIMENTAL

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; Device: Low-level laser therapy

Interventions

Grape Seed Extract DRUG

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

Also known as: GSE

Combination of low-level laser therapy and grape seed extract; Grape seed extract

Low-level laser therapy 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

Combination of low-level laser therapy and grape seed extract; Low-level laser therapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manipal University College Malaysia: lead

Study Sites (1)

Manipal University College Malaysia

Melaka Tengah, Melaka, 75450, Malaysia

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Grape Seed Extract; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anchu R Thomas

CONTACT

+601127292297; rachel.thomas@manipal.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: July 3, 2023
• Study Start: May 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)