NCT04548674

Brief 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%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

September 1, 2020

Last Update Submit

September 8, 2020

Conditions

Keywords

TherapiesCaspase 3Immunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • Pulp inflammation

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

    3 days After extraction of third molars

Study Arms (5)

Positive Control Group

PLACEBO COMPARATOR

Whiteness HP 35%

Other: Whiteness HP 35%

Laser Group

EXPERIMENTAL

Whiteness HP 35% + Laser

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

CPP Group

EXPERIMENTAL

Whiteness HP 35% + CPP

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

Nano Group

EXPERIMENTAL

Whiteness HP 35% + NANO

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

Negative Control

NO INTERVENTION

Without intervention

Interventions

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

CPP GroupLaser GroupNano GroupPositive Control Group

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.

Laser Group

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.

CPP Group

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.

Nano Group

Eligibility Criteria

Age20 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Pará

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Spinocerebellar Ataxias

Interventions

Lasers6-chloro-2-(1-piperazinyl)pyrazine

Condition Hierarchy (Ancestors)

Cerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinocerebellar DegenerationsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesAtaxiaDyskinesiasNeurologic ManifestationsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Clínico

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 14, 2020

Study Start

August 20, 2018

Primary Completion

March 15, 2019

Study Completion

June 30, 2019

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations