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Completed

NCT Number: NCT04855279

Prevention of Bleaching Induced Sensitivity

This study aims to evaluate the use of different desensitizing agents before in-office bleaching. A total of 64 volunteers were randomly divided into four groups. Before undergoing in-office bleaching with 38% hydrogen peroxide gel (three applications of 15 minutes each, one session), clinicians applied a placebo gel (control group), casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), neutral sodium fluoride gel (NSF), or nano-hydroxyapatite solution (n-HAP) on all buccal surfaces of teeth. The gel was left undisturbed for 4 minutes. Patients recorded their tooth sensitivities on the VAS scale. Kruskal-Wallis test followed by Mann-Whitney U test were used to compare changes in tooth color and intensity of tooth sensitivity between groups.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

About this study

Color evaluation was performed with Vita Shade Guide Classical (Vitapan Classical, Vita, Bad Sakingen, Germany). The shades were evaluated with shade guide units (SGUs). Vita Classical Shade Guide consisted of 16 shades, and the shades were aligned light-to-dark from B1-C4.21, 22 The shades were taken before and after 24 hours and 7 days of treatment.Next, the hypersensitivity was recorded by asking each subject to establish his or her perception of sensitivity before treatment using a visual analog scale (VAS). A stimulus of an evaporative blowing triple syringe (25 psi at ambient conditions) was applied for 3 seconds on the upper central incisors from a distance of 1 cm. After 24 hours and 7 days of bleaching treatment, stimuli testing was performed again.The subjects were divided into four groups. Group 1. Subjects were treated with a placebo gel. The agent was applied for 4 min. to all the teeth to be bleached. Group 2. Subjects were treated with ACP-CCP gel (Tooth Mousse, GC Corp., Tokyo, Japan) for 4 min. to all the teeth to be bleached. Group 3. Subjects were treated with nano-hydroxyapatite solution for 4 min. to all the teeth to be bleached. Group 4. Subjects were treated with neutral sodium fluoride (NSF) gel for 4 min. to all the teeth to be bleached. After treatment, the agent was removed by washing with water in all groups. Each subject underwent one session of bleaching on the anterior teeth from canine-to-canine. Bleaching systems were applied according to the manufacturer's instructions by one of the authors. Subjects were treated with hydrogen peroxide at 38% activated by a light source composed of 12 LEDs with blue light generators. The calculated hypersensitivity values and color change values were tested with Shapiro-Wilk and Levene tests for normal data distribution and homogeneity of variances. Kruskal-Wallis test followed by Mann-Whitney U test was performed to compare groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Must have all their upper and lower anterior teeth

Must have good oral hygiene

Exclusion criteria

Pregnancy or breastfeeding

Systemic disease

Taking NSAIDs or other drug treatment.

Periodontal disease

Enamel hypoplasia

Teeth stained by tetracycline or fluorosis

Dental malposition or orthodontic treatment with fixed appliances

Canine teeth lighter than A1

Restoration on anterior teeth

Cervical lesions

Symptoms of dental pain

Previous tooth whitening experience.

Treatment and study plan

neutral sodium fluoride

Other

Topically applied

ACP-CCP gel

Other

Topically applied

nano-hydroxyapatite solution

Other

Topically applied

glycerine

Other

Topically applied

Primary outcomes

  1. Effect of reducing hypersensitivity after bleaching

    Time frame: 1 week

    VAS scale (Visual Analog Scale) was measured before and after bleaching

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2021
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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