Prevention of Bleaching Induced Sensitivity
Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedFirst Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedApril 28, 2021
April 1, 2021
6 months
April 19, 2021
April 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of reducing hypersensitivity after bleaching
VAS scale (Visual Analog Scale) was measured before and after bleaching
1 week
Study Arms (4)
Control
PLACEBO COMPARATORTopical neutral sodium fluoride
ACTIVE COMPARATORACP-CCP gel
ACTIVE COMPARATORnano-hydroxyapatite solution
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Must have all their upper and lower anterior teeth
- Must have good oral hygiene
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medipol Mega University Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 21488723BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benin Dikmen, Dr.
Medipol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof. Dr.
Study Record Dates
First Submitted
April 19, 2021
First Posted
April 22, 2021
Study Start
January 7, 2019
Primary Completion
June 28, 2019
Study Completion
July 26, 2019
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share