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

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154941
• Other study ID #: Giomer-CPPACP-Varnish
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: Faculty of Dentistry Cairo university
• Phone: 010 02159535
• Email: dentmail[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Several approaches to dentin hypersensitivity treatment were proposed to interfere, whether transiently or permanently, with the hydrodynamic theory. These approaches include root coverage and the use of lasers, ions, dentinal sealants, and occluding and nerve depolarization agents, chosen according to the primary cause. There are two major strategies in managing DH; the first is nerve desensitization, and the second is the physical occlusion of the patent tubule. The second approach can be carried out through a wide range of treatment modalities, including the use of proteins, salts or ions to plug the tubules. Many agents introduced are capable of sealing dentinal tubules, and can be used to reduce sensitivity. Of these agents are CPP-ACP varnish and the newly introduced giomer based varnish wilth S-PRG technology

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Procedure:
• Giomer Varnish
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
• CPP-ACP varnish
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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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