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CompletedNCT02942082Updated Sep 18, 2019

Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching

An interventional study of ACP oral care gel and glycrin in Tooth Bleaching, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-18.

Sponsored by Cairo University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.

Read the detailed description

A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.

02

Conditions studied

  • Tooth Bleaching

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03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 36 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients must show no signs of spontaneous dental pain.
  • Male or female patients between the ages of 18 to 40.
  • Patients with good general and oral health.
  • Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
  • Patients should have central incisors determined to be shade C2 or darker

Exclusion criteria

Exclusion Criteria:

  • Patient with spontaneous dental pain.
  • Patient with anterior restorations or non carious cervical lesion.
  • Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
  • Tempro-mandibular joint problems involving symptomatic pain.
  • Patients taking analgesics that could alter their normal pain perception level.
  • Pregnant or breast feeding women.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    ACP oral care geldesensitizing agent

    a desensitizing agent will be applied on tooth before and /or after bleaching.

    Other: ACP oral care gel

  • Placebo comparator
    glycrin

    glycrin will be applied on tooth before and /or after bleaching.

    Other: glycrin

Interventions

  • OtherACP oral care gel

    a desensitizing agent will be applied on tooth before and/or after bleaching

  • Otherglycrin

    glycrin will be applied on tooth surface before and/or after bleaching

06

What researchers measure

Primary outcomes

  1. Post-bleaching hypersensitivity assessed using visual analogue scale

    using visual analogue scale

    Time frame: one month

Secondary outcomes

  1. Tooth color assessed using value-ordered VITA® Classical Shade Guide

    value-ordered VITA® Classical Shade Guide

    Time frame: one month

07

Study locations

1 site
  • Faculty of dentistry Cairo university
    Cairo, 11651, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02942082
Lead sponsor
Cairo University
Responsible party
Silvia Sabry (researcher, Cairo University) — Principal investigator
First posted
Oct 21, 2016
Start date
Nov 1, 2017
Primary completion
Sep 1, 2018
Completion
Nov 29, 2018
Last update
Sep 18, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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