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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06154941

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dentin Hypersensitivity	Procedure: Giomer Varnish Procedure: CPP-ACP varnish	N/A

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Giomer based Varnish	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
Active Comparator: CPP-ACP based varnish	Procedure: 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

Arm

Intervention/Treatment

Experimental: Giomer based Varnish

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

Active Comparator: CPP-ACP based varnish

Procedure: 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

Outcome Measures

Primary Outcome Measures

evaporative test [Immediately postoperative, after 1,3 and 6 months]
using an air blast from a conventional dental unit air-water syringe for 5 seconds.
Thermal Test [Immediately postoperative, after 1,3 and 6 months]
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 .
Tactile test [Immediately postoperative, after 1,3 and 6 months]
using the tip of a sharp explorer (number 3) to gently scratch the exposed cervical surface in an apico-coronal direction with short strokes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yomna sayed khallaf, lecturer at faculty of dentistry Cairo university, Cairo University

ClinicalTrials.gov Identifier:

NCT06154941

Other Study ID Numbers:

Giomer-CPPACP-Varnish

First Posted:

Dec 4, 2023

Last Update Posted:

Dec 4, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dentin Sensitivity

Hypersensitivity

Study Results

No Results Posted as of Dec 4, 2023