Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment

Study Overview
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Brief Summary
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The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.

Detailed Description
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Cervical dentin hypersensitivity is a painful condition and is a clinical challenge due to different treatment strategies available. The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity. A hundred forty teeth of healthy patients of both sexes were selected. Visual Analog Scale was used pain (VAS) to measure the intensity of the patient's pain. The teeth will be randomly divided into 7 different groups according to the desensitization treatment under study: Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.

Official Title
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Analysis of the Association of Products for the Treatment of Cervical Dentin Hypersensitivity

Conditions
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Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity, Dentine Hypersensitivity

Intervention / Treatment
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* Drug: Resin modified glass ionomer
* Drug: Potassium Nitrate 2%
* Procedure: Low level laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of dentin exposure lesions with clinical diagnosis of moderate or severe tooth sensitivity good oral hygiene. Exclusion Criteria: cavities, presence of periodontal disease and or parafunctional habits, cracks or enamel fractures, extensive or unsatisfactory restorations, recent restorations involving the labial surface, dentures, orthodontics.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resin modified glass ionomer (RMGI)<br>Resin modified glass ionomer; an application every 48 hours; 4 sessions. | Drug: Resin modified glass ionomer<br>* Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds<br>* Other names: Clinpro;|
| Active Comparator: Potassium Nitrate 2% (KF)<br>Potassium Nitrate and Sodium fluoride 2%; an application every 48 hours; 4 sessions. | Drug: Potassium Nitrate 2%<br>* Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.<br>* Other names: Desensibilize KF;|
| Active Comparator: Low level laser therapy - GaAlAs (LLLT)<br>Low level laser therapy - GaAlAs; an application every 48 hours; 4 sessions. | Procedure: Low level laser therapy<br>* Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.<br>* Other names: Photon Lase III;|
| Active Comparator: RMGI and KF<br>Resin modified glass ionomer and potassium nitrate and sodium fluoride 2%; an application of the two associated products, every 48 hours; 4 sessions. | Drug: Resin modified glass ionomer<br>* Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds<br>* Other names: Clinpro;Drug: Potassium Nitrate 2%<br>* Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.<br>* Other names: Desensibilize KF;|
| Active Comparator: RMGI and LLLT<br>Resin modified glass ionomer and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions. | Drug: Resin modified glass ionomer<br>* Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds<br>* Other names: Clinpro;Procedure: Low level laser therapy<br>* Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.<br>* Other names: Photon Lase III;|
| Active Comparator: KF and LLLT<br>Potassium Nitrate and Sodium fluoride 2% and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions. | Drug: Potassium Nitrate 2%<br>* Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.<br>* Other names: Desensibilize KF;Procedure: Low level laser therapy<br>* Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.<br>* Other names: Photon Lase III;|
| Active Comparator: RMGI, KF, LLLT<br>Resin modified glass ionomer, potassium nitrate and sodium fluoride 2% and Low level laser therapy - GaAlAs ; an application of the three associated products, every 48 hours; 4 sessions. | Drug: Resin modified glass ionomer<br>* Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds<br>* Other names: Clinpro;Drug: Potassium Nitrate 2%<br>* Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.<br>* Other names: Desensibilize KF;Procedure: Low level laser therapy<br>* Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.<br>* Other names: Photon Lase III;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of cervical dentin hypersensitivity, measured by visual analog scale | Evaluate the reduction in Cervical Dentin Hypersensitivity with a 24 weeks follow up. | 24 weeks |