Effectiveness of Office Bleaching Agents in Patients of Different Age Group

Study Overview
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Brief Summary
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To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute risk and intensity of dentin sensitivity due to dental bleaching in the office with 35% hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent, South Jordan, UT, USA) in the same arch in patients of different age groups: 18 to 25 years and 40 to 65 years. Data will be collected, tabulated and submitted to statistical analysis

Detailed Description
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Throughout life, the aging of the human being as a whole is inevitable. The dental structure such as cementum and dentin undergo some changes over time, such as secondary deposition of dentin, which results in the reduction of root canal length. In addition, with aging the teeth undergo color changes, presenting a more yellowish or grayish coloration (Ravindra SV et al., 2015). The fact is that most of the studies that involve the technique of dental bleaching have as inclusion factor only young adult patients, excluding patients of more advanced age groups. Therefore, it is fundamental to evaluate the whitening technique in these older patients, since it is a treatment that does not cause harm to the individuals To assess the effect of dental bleaching in the office with Whiteness HP Automixx, FGM at 35% and Opalescence Boost at 38% in the same arch, in different age groups (18 to 25 years and 40 to 65 years) in absolute risk and intensity Of the postoperative dental sensitivity through the visual analog (VAS 0-10) and analogue (NRS 0-4) scales. Evaluate the efficacy of Whitening HP Automixx, FGM 35% and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years) using Color Vita Classical and Vita Bleachedguide, and the Vita Easyshade spectrophotometer. Evaluate the satisfaction of patients after Whitening HP Automixx at 35, FGM and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years).

Official Title
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Randomized Clinical Trial Comparing the Effectiveness of Office Bleaching Agents in Patients of Different Age Group

Conditions
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Satisfaction

Intervention / Treatment
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* Drug: Hydrogen peroxide 35%
* Drug: Hydrogen peroxide 38%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age up to 25 years Patients aged 40 years up to 65 years Good oral and general health Teeth free of restorations or with small restorations Free from carious injury, Patients with tooth color A2 or darker according to the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany) Agree to the informed consent form Exclusion Criteria: extensive restoration Patients who have already undergone dental whitening Pregnant or lactating women That report dental sensitivity With non-carious cervical lesion Parafunctional habits Orthodontic appliances Any other type of oral pathology Smokers, patients who are using analgesic or anti-inflammatory drugs, present systemic alterations such as gastric, cardiac, renal and hepatic problems, diabetics, hypertensives or pre-existing neoplasias.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: range of patients aged 18 to 25 years receiving two types of geis and range of patients aged 40-65 years receiving two types of geis
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Young Patient<br>With 18-25 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38% | Drug: Hydrogen peroxide 35%<br>* The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.<br>* Other names: Hydrogen peroxide 38%;Drug: Hydrogen peroxide 38%<br>* The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.<br>* Other names: Hydrogen peroxide 35%;|
| Other: Adult Patient<br>With 40-65 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38% | Drug: Hydrogen peroxide 35%<br>* The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.<br>* Other names: Hydrogen peroxide 38%;Drug: Hydrogen peroxide 38%<br>* The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.<br>* Other names: Hydrogen peroxide 35%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth discoloration | Efficacy of office dental whitening mensured by Easyshade spectrophotometer. | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentin sensitivity | It will analised the risk and intensity of tooth sensitivity of dental bleaching | 36 weeks | 
| Patient satisfaction | It will analised the patient satisfaction by questionnaire of self-perception of aesthetics (PIDAQ) | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental whitening, Dental office whitening