- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05981625
Desensitizing Effect and Tooth Color Change After Using Giomer-based Varnish Versus Bioactive Glass Air Polishing in Treating Cervical Hypersensitive Lesions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo Governorate
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Cairo, Cairo Governorate, Egypt, 1151
- Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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)
|
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 |
|
Active Comparator: Bioactive Glass Air Polishing
Bioactive glass powder delivered by an air-polishing device (ProJet 1) equipped with a 0.6-mm-diameter nozzle and a particle size range: 38-90 µm .
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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain due to dentin hypersenstivity
Time Frame: baseline preoperative, immediate postoperative, 1 , 6 and 12-months' time
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Dentin hypersensitivity was assessed by three different stimuli (evaporative , thermal and tactile) to simulate the different situations in which Dentin hypersensitivity arises. Using the Visual Analog scale (VAS), the participant marks the pain intensity on a graduated 10 cm straight line (0 = no pain, 10 = extreme pain) |
baseline preoperative, immediate postoperative, 1 , 6 and 12-months' time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Color change (Tooth discoloration)
Time Frame: Baseline preoperative, immediate postoperative, 1,6 and 12-months time
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According to the Modified USPH criteria Alpha: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch
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Baseline preoperative, immediate postoperative, 1,6 and 12-months time
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14422022559057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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