Clinical trial NCT05927831: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dentin Hypersensitivity
Lead sponsor: Manipal University College Malaysia
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
timeFrame: 1st day
measure: The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
timeFrame: 3rd day
measure: The patients' dentin hypersensitivity levels will be measured using a visual analogue scale (VAS)
timeFrame: 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Melaka Tengah
country: Malaysia
facility: Manipal University College Malaysia
state: Melaka
Study officials:
affiliation: Manipal University College Malaysia
name: Tun Yi Darren Ong
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal University College Malaysia
name: Li Jia Ong
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal University College Malaysia
name: Ju Wen Lim
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal University College Malaysia
name: Wei Nee Lim
role: PRINCIPAL_INVESTIGATOR
affiliation: Manipal University College Malaysia
name: Gursimrendeep Kaur
role: PRINCIPAL_INVESTIGATOR
References: