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

NCT ID: NCT06154941

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-08-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Giomer based Varnish

Group Type EXPERIMENTAL

Giomer Varnish

Intervention Type 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

CPP-ACP based varnish

Group Type ACTIVE_COMPARATOR

CPP-ACP varnish

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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yomna sayed khallaf

lecturer at faculty of dentistry Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Faculty of Dentistry Cairo university

Role: CONTACT

Phone: 010 02159535

Email: [email protected]

Facility Contacts

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yomna khallaf, master

Role: primary

Other Identifiers

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Giomer-CPPACP-Varnish

Identifier Type: -

Identifier Source: org_study_id