Grape Seed Extract VS Low Level Laser Therapy for Dentin Hypersensitivity

NCT ID: NCT05927831

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Grape Seed Extract

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Low-level laser therapy

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Grape Seed Extract

Intervention Type: DRUG

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

Low-level laser therapy

Intervention Type: 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

Interventions

Grape Seed Extract

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

Intervention Type: DRUG

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

Intervention Type: DEVICE

Other Intervention Names

GSE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Manipal University College Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anchu Rachel Thomas

Associate Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tun Yi Darren Ong

Role: PRINCIPAL_INVESTIGATOR

Manipal University College Malaysia

Li Jia Ong

Role: PRINCIPAL_INVESTIGATOR

Manipal University College Malaysia

Ju Wen Lim

Role: PRINCIPAL_INVESTIGATOR

Manipal University College Malaysia

Wei Nee Lim

Role: PRINCIPAL_INVESTIGATOR

Manipal University College Malaysia

Gursimrendeep Kaur

Role: PRINCIPAL_INVESTIGATOR

Manipal University College Malaysia

Locations

Manipal University College Malaysia

Melaka Tengah, Melaka, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Anchu R Thomas

Role: CONTACT

rachel.thomas@manipal.edu.my

+601127292297

Facility Contacts

Anchu R Thomas

Role: primary

rachel.thomas@manipal.edu.my

+601127292297

Other Identifiers

018/2023

Identifier Type: -

Identifier Source: org_study_id