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

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: Giomer varnish containing surface pre-reacted glass fillers


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Giomer varnish containing surface pre-reacted glass fillers<br>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) | Other: Giomer varnish containing surface pre-reacted glass fillers<br>* 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<br>|
| Active Comparator: Bioactive Glass Air Polishing<br>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 | Other: Giomer varnish containing surface pre-reacted glass fillers<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain due to dentin hypersenstivity | 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) | According to USPH criteria Alpha: Matches tooth Bravo: Acceptable mismatch Charlie: Unacceptable mismatch | Baseline preoperative, immediate postoperative, 1,6 and 12-months time |