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Prevention of Bleaching Induced Sensitivity

Primary Purpose

Tooth Bleaching, Tooth Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
neutral sodium fluoride
ACP-CCP gel
nano-hydroxyapatite solution
glycerine
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tooth Bleaching

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medipol Mega University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

Topical neutral sodium fluoride

ACP-CCP gel

nano-hydroxyapatite solution

Arm Description

Outcomes

Primary Outcome Measures

Effect of reducing hypersensitivity after bleaching
VAS scale (Visual Analog Scale) was measured before and after bleaching

Secondary Outcome Measures

Full Information

First Posted
April 19, 2021
Last Updated
April 26, 2021
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04855279
Brief Title
Prevention of Bleaching Induced Sensitivity
Official Title
Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Bleaching, Tooth Sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Topical neutral sodium fluoride
Arm Type
Active Comparator
Arm Title
ACP-CCP gel
Arm Type
Active Comparator
Arm Title
nano-hydroxyapatite solution
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
neutral sodium fluoride
Intervention Description
Topically applied
Intervention Type
Other
Intervention Name(s)
ACP-CCP gel
Intervention Description
Topically applied
Intervention Type
Other
Intervention Name(s)
nano-hydroxyapatite solution
Intervention Description
Topically applied
Intervention Type
Other
Intervention Name(s)
glycerine
Intervention Description
Topically applied
Primary Outcome Measure Information:
Title
Effect of reducing hypersensitivity after bleaching
Description
VAS scale (Visual Analog Scale) was measured before and after bleaching
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benin Dikmen, Dr.
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medipol Mega University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21488723
Citation
Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
Results Reference
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Prevention of Bleaching Induced Sensitivity

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