NCT02718183

Brief Summary

OBJECTIVES: The aim of this clinical randomized, double-blind clinical study was to assess the markers levels of RANKL IL-1B and OPGL, involved in the external cervical resorption as a primary outcome, and change color effectiveness in patients undergoing intracoronary bleaching. METHOD: 46 volunteers (50 teeth) participated with discoloration on non-vital teeth, with the endodontic treatment in good condition. Patients were randomly located into two study groups according to product G1 = 35% hydrogen peroxide (n = 25) and G2 = 37% carbamide peroxide (n = 25). The intracameral bleaching was performed with a walking bleaching technique of 4 sessions Gingivocrevicular transudate samples were taken to determine levels of Il1b, RANKL, and OPGL with absorbent paper (Periopaper®), they are obtained from six sites per tooth bleaching: 3 vestibular and three palatine (mesial, middle and distal), in 6 opportunities: Baseline, after 4-sessions of intracameral bleaching and a one week after treatment. Total proteins are quantified by Bradford ® system and from the eluted sample of RANKL, IL 1b and OPGL levels measured by ELISA (Quantikine®; R\&D Systems Inc.). The color was evaluated in each session with Vita EasyShade spectrophotometer is used with the CIEL\*a\*b system to measure the total variation in color (ΔE), between the baseline and the different evaluation times.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

March 16, 2016

Last Update Submit

March 23, 2016

Conditions

Discolored Teeth

Outcome Measures

Primary Outcomes (1)

  • Bone destruction markers in gingival fluids

    \[Interleukin 1b , RANK-L, OPG \] (pg/ml)

    1 year

Study Arms (2)

PH

EXPERIMENTAL

Hydrogen peroxide 35% to intracoronal bleaching in discoloration teeth eith endodontic treatment

Other: Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA)

PC

EXPERIMENTAL

Carbamide peroxide 37% to intracoronal bleaching in discoloration teeth eith endodontic treatment

Other: carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).

Interventions

Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA)OTHER

bleaching teeth gel to intracameral use.

Also known as: Hp 35%
PH
carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).OTHER

bleaching teeth gel to intracameral use.

Also known as: Cp 37%
PC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years,
  • with one or more non-vital teeth,
  • the restoration does not cover the vestibular face of teeth,
  • endodontic treatment is in good condition, without apical lesion,
  • with no previous experience of tooth whitening and tooth shade A2 or greater according to the Vita Classical scale.

You may not qualify if:

  • excluded pregnant or lactating,
  • patients with enamel hypoplasia,
  • with teeth stained by tetracycline or fluorosis,
  • in orthodontic treatment with fixed appliances,
  • patients with cancer or periodontal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Miranda CB, Mayer C, Ledezma P, Vernal R, Rivera O, Godoy EF. Persistent Inflammatory Response in Periodontal Tissues After Walking Bleach: A Clinical Biomarker-Based Study. Aust Endod J. 2025 Dec;51(3):619-631. doi: 10.1111/aej.12975. Epub 2025 Jul 16.

    PMID: 40667613DERIVED

  • Bersezio C, Martin J, Mayer C, Rivera O, Estay J, Vernal R, Haidar ZS, Angel P, Oliveira OB Jr, Fernandez E. Quality of life and stability of tooth color change at three months after dental bleaching. Qual Life Res. 2018 Dec;27(12):3199-3207. doi: 10.1007/s11136-018-1972-7. Epub 2018 Aug 21.

    PMID: 30132252DERIVED

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Hydrogen PeroxideCarbamide Peroxide

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic ChemicalsUreaAmides

Study Officials

  • eduardo fernandez

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 24, 2016

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

February 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share