Clinical Evaluation of Giomer Based Varnish Versus CPP-ACP Varnish in the Management of Dentin Hypersensitivity: a Randomized Clinical Trial

NCT06154941 | Unknown

• 1 other identifier: Giomer-CPPACP-Varnish
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Dentin hypersensitivity is a drastic problem, which threaten many dental patients. According to the last published systematic review and meta analysis at 2019, the prevalence of dentin hypersensitivity is being 33.5% among the population. Moreover, it was determined that young adults with age range from 18 to 44 years exhibited high percentage (43.9%) of such problem

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• evaporative test

  using an air blast from a conventional dental unit air-water syringe for 5 seconds.

  Immediately postoperative, after 1,3 and 6 months

• Thermal Test

  using anaesthetic carpule kept in the refrigerator at 4oC for at least 24 hours till it became ice then it is removed from refrigerator immediately before testing .

  Immediately postoperative, after 1,3 and 6 months

• Tactile test

  using the tip of a sharp explorer (number 3) to gently scratch the exposed cervical surface in an apico-coronal direction with short strokes.

  Immediately postoperative, after 1,3 and 6 months

Study Arms (2)

Giomer based Varnish

EXPERIMENTAL

Procedure: Giomer Varnish

CPP-ACP based varnish

ACTIVE COMPARATOR

Procedure: CPP-ACP varnish

Interventions

Giomer Varnish PROCEDURE

A light-cured Giomer varnish for prolonged hypersensitivity relief. Seals and protects exposed dentinal tubules to prevent pain. Ideal for patients experiencing loss of enamel, gingival recession

Giomer based Varnish

CPP-ACP varnish PROCEDURE

CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. CPP-ACP Varnish delivers bioavailable calcium and phosphate ions to occlude dentinal tubules treating dentin hypersensitivity

CPP-ACP based varnish

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants of both genders aged 18 to 40 years with good oral hygiene, suffering from pain due to dentin hypersensitivity in at least one tooth

You may not qualify if:

• Taking desensitizing treatment in the last 6 months. (It affects the outcome)
• Taking anti-inflammatory drugs. (It affects the hypersensitivity perception)
• Pregnant females. ( They complain from nausea and repeated vomiting attacks)
• Smokers. (Smoking will affect the oral hygiene and periodontal health)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Faculty of Dentistry Cairo university

CONTACT

010 02159535; dentmail@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at faculty of dentistry Cairo university

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

EG (1)