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CompletedNCT04548674Updated Sep 14, 2020

Analysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth

An interventional study of Whiteness HP 35% and Whiteness HP 35% + LASER in Pulp Inflammation, sponsored by Universidade Federal do Para. Completed at 1 site in Brazil. Open to participants aged 20 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-14.

Sponsored by Universidade Federal do Para · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Aug 2018, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
20 Years to 26 Years
Sex
All
01

Study summary

This randomized, controlled, blinded clinical trial evaluated the effectiveness of different desensitizing protocols in preventing pulp inflammation after bleaching treatment with 35% hydrogen peroxide (PH) (Whiteness PH 35%).

Read the detailed description

Thirty healthy third human molars extracted by orthodontic indication were randomized and allocated into five groups (n = 6): CN (negative control): without intervention; CP (Positive control): PH; PMB: PH + photobiomodulation with low power laser; CPP: PH + casein phosphopeptide phosphopeptide amorphous calcium phosphate (CPP-ACPF); NANO: PH + nanohydroxyapatite. The office whitening was performed in two sessions with a single application of 45 min and an interval of 48 hours between them. Pulp tissues were removed for immunohistochemical analysis. Immunostaining was performed for Caspase 3 using an Axio Scope.A1 microscope.

02

Conditions studied

  • Pulp Inflammation

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Keywords

  • Therapies
  • Caspase 3
  • Immunohistochemistry
03

In context

Inflammation

3,438 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 18 is below the median of 50 across 2,436 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Universidade Federal do Para is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Lower third molars class I position A
  • Maxillary third molars horizontal position A
  • Absence of caries and enamel fracture
  • Absence of periodontal disease
  • Extraction of third molars for orthodontic reasons
  • No allergy to the anesthetic and positive pulp sensitivity test

Exclusion criteria

Exclusion criteria:

  • Calcification in the middle third of the root
  • Drug users or smokers
  • Patients who have already done whitening
  • Root apex with incomplete formation and patients with systemic problems that would make surgery impossible
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Placebo comparator
    Positive Control Group

    Whiteness HP 35%

    Other: Whiteness HP 35%

  • Experimental
    Laser Group

    Whiteness HP 35% + Laser

    Other: Whiteness HP 35% · Device: Whiteness HP 35% + LASER

  • Experimental
    CPP Group

    Whiteness HP 35% + CPP

    Other: Whiteness HP 35% · Other: Whiteness HP 35% + CPP

  • Experimental
    Nano Group

    Whiteness HP 35% + NANO

    Other: Whiteness HP 35% · Other: Whiteness HP 35% + NANO

  • No intervention
    Negative Control

    Without intervention

Interventions

  • OtherWhiteness HP 35%

    Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm

  • DeviceWhiteness HP 35% + LASER

    A dose of LASER (60 J / cm2, for 16 seconds) was applied at two points, one point in the cervical region and another in the center of the buccal surface of the third molars, using visible infrared LASER therapy (Photon III / DMC, São Carlos, SP, Brazil), with a wavelength of 808 nm, and AsGaAl, as an active medium.

  • OtherWhiteness HP 35% + CPP

    Topical application of casein phosphopeptide amorphous calcium phosphate fluoride CPP-ACPF (My Paste Plus, Recaldent, GC, USA) with the aid of a microbrush (KG Sorensen, SP, Brazil) in a passive way for 5 minutes.

  • OtherWhiteness HP 35% + NANO

    A topical application of nanohydroxyapatite (Nano P FGM, SC, Brazil) was performed with the aid of a microbrush (KG Sorensen, SP, Brazil) in a passive way for 5 minutes after teeth whitening.

06

What researchers measure

Primary outcomes

  1. Pulp inflammation

    Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not

    Time frame: 3 days After extraction of third molars

07

Study locations

1 site
  • Universidade Federal do Pará
    Belém, Pará 66075-110, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04548674
Lead sponsor
Universidade Federal do Para
Responsible party
Cecy Martins Silva (Professor Clínico, Universidade Federal do Para) — Principal investigator
First posted
Sep 14, 2020
Start date
Aug 20, 2018
Primary completion
Mar 15, 2019
Completion
Jun 30, 2019
Last update
Sep 14, 2020

Oversight

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 2020. You cannot join it, but the record below documents what was studied.

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