Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions

NCT ID: NCT05981625

Last Updated: 2023-08-08

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2026-03-31

Brief Summary

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This trial is test the dentin hypersenstivity using Giomer based Varnish versus Bioactive glass air polishing system in patients with non-cervical lesions.

Detailed Description

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To investigate the clinical effectiveness of Giomer based varnish versus Bioactive glass air polishing System in the management of dentin hypersensitivity and tooth color change in the cervical lesions.

P:Patient/Population: Middle aged patients complaining of cervical dentin hypersensitivity. I: Giomer varnish containing surface pre-reacted glass fillers. C: Bio-active glass air polishing system: O:Dentin Hypersenstivity (Primary Outcome) was assessed by three different stimuli (evaporative , thermal and tactile) . O: Color Change (Secondary Outcome). T: Baseline, T1, T2, T3. S:a randomized clinical trial.

Conditions

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Dentin Hypersensitivity, Non-carious Cervical Lesions, Bioactive Glass Air Polishing, S-PRG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Giomer varnish containing surface pre-reacted glass fillers

Giomer-based varnish is a light-curable varnish/desensitizer. The surface pre-reacted glass (S-PRG) filler is a bioactive trilaminar structure with a multifunctional glass core embedded in resin matrix. It can release and recharge fluoride ions. When it becomes in contact with the oral fluids, it starts to bind to the collagen fiber and release six different types of ions like fluoride, calcium, phosphate that help in the formation of apatite crystals and seal the open dentinal tubules with a long-lasting effect Brand name: S\_PRG (Shofu-Japan)

Group Type EXPERIMENTAL

Giomer varnish containing surface pre-reacted glass fillers

Intervention Type OTHER

Giomer varnish (PRG barrier coat) will used as the intervention agent in this study. , Giomer is considered as a hybrid material between the resins modified glass ionomers and the composite resins. It is composed of 45% Sio2, 24.5% Na2O, 24.5% Ca O and 6% P2O5

. The presence of sodium is very important due to its bioactivity while the phosphate is responsible for the degree of degradation and formation of apatite. Based on this composition, giomer has several clinical applications in implant, periodontics, bone generation, pulp capping, Root canal treatment, as restorative materials, in air abrasion, enamel remineralization and finally dentin hypersensitivity

Bioactive Glass Air Polishing

Bioactive glass powder delivered by standalone air polishing system, is a bioactive material that reacts with saliva to deposit Hydroxycarbonate Apatite crystals (HCA), which is very strong and resilient. The continuous release of calcium ions promotes constant protection and long lasting seal of the tubules. Using the air polishing delivery system helps to provide a huge amount of calcium and phosphate particles at the exposed surface of the tooth. Moreover, the air pressure aids in pushing these particles inside the dentinal tubules to a considerable depth. Air polishing using such powder provides a bifunctional advantage of occluding the dentinal tubules. However, there is limited clinical trials testing the efficacy of the bioactive glass powder air polishing system in minimizing the dentin hypersensitivity

Group Type ACTIVE_COMPARATOR

Giomer varnish containing surface pre-reacted glass fillers

Intervention Type OTHER

Giomer varnish (PRG barrier coat) will used as the intervention agent in this study. , Giomer is considered as a hybrid material between the resins modified glass ionomers and the composite resins. It is composed of 45% Sio2, 24.5% Na2O, 24.5% Ca O and 6% P2O5

. The presence of sodium is very important due to its bioactivity while the phosphate is responsible for the degree of degradation and formation of apatite. Based on this composition, giomer has several clinical applications in implant, periodontics, bone generation, pulp capping, Root canal treatment, as restorative materials, in air abrasion, enamel remineralization and finally dentin hypersensitivity

Interventions

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Giomer varnish containing surface pre-reacted glass fillers

Giomer varnish (PRG barrier coat) will used as the intervention agent in this study. , Giomer is considered as a hybrid material between the resins modified glass ionomers and the composite resins. It is composed of 45% Sio2, 24.5% Na2O, 24.5% Ca O and 6% P2O5

. The presence of sodium is very important due to its bioactivity while the phosphate is responsible for the degree of degradation and formation of apatite. Based on this composition, giomer has several clinical applications in implant, periodontics, bone generation, pulp capping, Root canal treatment, as restorative materials, in air abrasion, enamel remineralization and finally dentin hypersensitivity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants complaining from dentin hypersensitivity.
* Middle aged patients.
* Good oral hygiene.

Exclusion Criteria

* Pregnant women.
* Patients with allergy to any material used in this study.
* Smoking patients will affect the oral hygiene and periodontal health.
* Patients taking anti-inflammatory drugs that will affect the perception of hypersensitivity.
* Systemically compromised patients.
* Smokers.
* Patients received desensitization treatment in the last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 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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omnia samy Garouda

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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omnia Samy Garouda, master's

Role: CONTACT

00201273573591

Asmaa Yaseen, Professor

Role: CONTACT

References

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Ravishankar P, Viswanath V, Archana D, Keerthi V, Dhanapal S, Lavanya Priya KP. The effect of three desensitizing agents on dentin hypersensitivity: A randomized, split-mouth clinical trial. Indian J Dent Res. 2018 Jan-Feb;29(1):51-55. doi: 10.4103/ijdr.IJDR_458_17.

Reference Type BACKGROUND
PMID: 29442087 (View on PubMed)

West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.

Reference Type BACKGROUND
PMID: 24993261 (View on PubMed)

Favaro Zeola L, Soares PV, Cunha-Cruz J. Prevalence of dentin hypersensitivity: Systematic review and meta-analysis. J Dent. 2019 Feb;81:1-6. doi: 10.1016/j.jdent.2018.12.015. Epub 2019 Jan 11.

Reference Type BACKGROUND
PMID: 30639724 (View on PubMed)

Freitas Sda S, Sousa LL, Moita Neto JM, Mendes RF, Prado RR. Dentin hypersensitivity treatment of non-carious cervical lesions - a single-blind, split-mouth study. Braz Oral Res. 2015;29:45. doi: 10.1590/1807-3107BOR-2015.vol29.0045. Epub 2015 Mar 10.

Reference Type BACKGROUND
PMID: 25760065 (View on PubMed)

Other Identifiers

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14422022559057

Identifier Type: -

Identifier Source: org_study_id

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