Discolored TeethBLEICNCT02718183
Effect on Periodontal Markers by Bleaching Intracoronal Technique
A study testing Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA) and carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil). in people with Discolored Teeth, run by University of Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Discolored Teeth
- What is being tested?
- Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA) and carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effect on Periodontal Markers Interleukin-RANK by Walking Bleaching Non-Vital Technique: Clinical Randomized Double-blind Trial
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).
Read more
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.
Read the detailed description
The trial was randomized and double-blind (patient and operator). Advertising was held to invite participation in dental school and through social networks like Facebook or Twitter.
Sample size
To determine the size of the sample GPower 3.1 software was used, considering a significance level of 5% statistical power of 80%.
A total of 74 patients were examined to assess whether they met the criteria for inclusion and exclusion. Patients: over 18 years, with one or more non-vital teeth, the restoration does not cover the vestibular face, 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. Patients were 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. In addition to those volunteers to be examined clinically and radiographically present caries, periapical lesions, external or internal dental resorption and / or periodontal disease, as may be informed and referred to specialists for treatment.
46 patients, of whom 44 completed treatment and attended all controls were selected.
Were formed at randomization two study groups as the bleaching agent used, each with teeth n = 25, G1 = teeth bleached with Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA). G2 = bleached teeth with carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).
Bleaching procedure
The application of the bleaching agents was performed according to manufacturers instructions in four sessions with an outpatient technique (Walking Bleaching), with one week apart from each.
Session Preparation: Preparing root canal with absolute isolation, were removed from 3mm seal the endodontic cement-enamel limit reference. The final sealing was made with 2mm with glass ionomer resin composite modificao and curing by (Riva Light Cure, SDI, Australia) and light-cured for 40 seconds (Cal Radii, SDI, Australia).
Unblocking a radiographic control and sealing the root canal, and radiographs, post seal was obtained.
4 sessions of Whitening: The Application of the bleaching agent was according to manufacturer's instructions. An amount of gel bleaching agent was left intracamerally with moisture (Walking Bleaching). Subsequently he sealed with a temporary cement to the next session.
Closing session: the access cavity was washed with water and a temporary sealing leave for 7 days prior to the completion of the final seal.
Patients were advised not to eat or drink foods that can stain, such as coffee, tea, red wine, etc. during the study period. They were given written instructions and contact information for any questions or problems arise.
Color Evaluation
Two calibrated evaluators, with 80% agreement (Kappa test), recorded the color of teeth at baseline (baseline), immediately after each bleaching session, one week and one month post-treatment.
Color evaluation was measured in the middle third of the labial surface of tooth bleaching. Patients were examined in the same room with the same lighting, for both examiners independently. using the Vita Bleachguide scale (Vita Zahnfabrik, Bad Säckingen, Germany) .For every "value" color is assigned a numerical value in order to calculate the change in units scale (SGU Δ).
Evaluation of markers RANKL-OPG-Interleukin in crevicular gingival fluid (FGC) Obtaining and handling of samples FGC
FGC samples were obtained from six sites periodontal 3 vestibular and 3 palatal / lingual (average mesial - distal) undergoing teeth whitening. Samples were taken before the whitening (baseline) and after each whitening session, a week and a month post-whitening.
For this were used Periopaper® absorbent paper strips (OraFlow Inc., New York, NY, USA). The teeth were isolated from a relative fashion using cotton rolls, once isolated with a Gracey 3/4 the supra-gingival plaque be removed and gently the surface of the triple air dry syringe. The paper strip was introduced into the selected tooth gingival sulcus until mild resistance tissue and held for 30 seconds. Then they were placed in properly labeled Eppendorf tubes and transported immediately to be stored at -80 ° C until the centrifugal elution process. The paper strips contaminated with saliva or blood were discarded.
The paper strips were subjected to centrifugal elution to obtain total proteins present in the FGC. To do this, incubated for 30 minutes in 100 .mu.l of elution buffer containing 0.05% Tween in Tris-HCl pH 7.4 (Fluka, Sigma-Aldrich Chemie GmbH, Buchs, Switzerland) and then centrifugarnn 10,000 xg for 5 minutes at 4 ° C. The process of centrifugal circumvention repetio 3 times to a final volume of 300 ul, which was stored at -80 ° C until analysis.
Evaluation of markers RANKL-OPG-Interleukin in crevicular gingival fluid (FGC) Total proteins were quantified by the Bradford ® system (R \& D Systems Inc., Minneapolis, MN, USA) and from 50 ul of sample eluted from medieronn levels of RANKL, OPG and interleukin by ELISA (Quantikine®; R \& D Systems Inc. ) following the manufacturer's protocol. The average absorbance at 492 nm with correction at 630 nm using an automated plate reader (Universal ELx800 Microplate Reader, Bio-Tek Instruments Inc., Winooski, VT, USA). The concentration of the markers in each sample was calculated using an equation of the line of 4th grade.
- Conditions
- Discolored Teeth
- Being tested
- Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA), carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA)Other
Also called Hp 35%
bleaching teeth gel to intracameral use.
carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).Other
Also called Cp 37%
bleaching teeth gel to intracameral use.
| Study group | Role | What they receive |
|---|---|---|
| PH | Experimental | Hydrogen peroxide 35% to intracoronal bleaching in discoloration teeth eith endodontic treatment Receives: Other: Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA) |
| PC | Experimental | Carbamide peroxide 37% to intracoronal bleaching in discoloration teeth eith endodontic treatment Receives: Other: carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone destruction markers in gingival fluids
[Interleukin 1b , RANK-L, OPG ] (pg/ml)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Discolored TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Fernandez, University of Chile
- Investigators
- eduardo fernandez, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718183
- Sponsor's protocol ID
- 03/16
- Acronym
- BLEIC
- Status last verified
- Mar 2016
- First submitted
- 16 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40667613Bersezio 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.
PubMed 30132252
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Periodontal Markers Interleukin-RANK by Walking Bleaching Non-Vital Technique: Clinical Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT02718183
- Acronym / sponsor ID
- BLEIC / 03/16
- Conditions
- Discolored Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial was randomized and double-blind (patient and operator). Advertising was held to invite participation in dental school and through social networks like Facebook or Twitter.
Sample size
To determine the size of the sample GPower 3.1 software was used, considering a significance level of 5% statistical power of 80%.
A total of 74 patients were examined to assess whether they met the criteria for inclusion and exclusion. Patients: over 18 years, with one or more non-vital teeth, the restoration does not cover the vestibular face, 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. Patients were 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. In addition to those volunteers to be examined clinically and radiographically present caries, periapical lesions, external or internal dental resorption and / or periodontal disease, as may be informed and referred to specialists for treatment.
46 patients, of whom 44 completed treatment and attended all controls were selected.
Were formed at randomization two study groups as the bleaching agent used, each with teeth n = 25, G1 = teeth bleached with Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA). G2 = bleached teeth with carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).
Bleaching procedure
The application of the bleaching agents was performed according to manufacturers instructions in four sessions with an outpatient technique (Walking Bleaching), with one week apart from each.
Session Preparation: Preparing root canal with absolute isolation, were removed from 3mm seal the endodontic cement-enamel limit reference. The final sealing was made with 2mm with glass ionomer resin composite modificao and curing by (Riva Light Cure, SDI, Australia) and light-cured for 40 seconds (Cal Radii, SDI, Australia).
Unblocking a radiographic control and sealing the root canal, and radiographs, post seal was obtained.
4 sessions of Whitening: The Application of the bleaching agent was according to manufacturer's instructions. An amount of gel bleaching agent was left intracamerally with moisture (Walking Bleaching). Subsequently he sealed with a temporary cement to the next session.
Closing session: the access cavity was washed with water and a temporary sealing leave for 7 days prior to the completion of the final seal.
Patients were advised not to eat or drink foods that can stain, such as coffee, tea, red wine, etc. during the study period. They were given written instructions and contact information for any questions or problems arise.
Color Evaluation
Two calibrated evaluators, with 80% agreement (Kappa test), recorded the color of teeth at baseline (baseline), immediately after each bleaching session, one week and one month post-treatment.
Color evaluation was measured in the middle third of the labial surface of tooth bleaching. Patients were examined in the same room with the same lighting, for both examiners independently. using the Vita Bleachguide scale (Vita Zahnfabrik, Bad Säckingen, Germany) .For every "value" color is assigned a numerical value in order to calculate the change in units scale (SGU Δ).
Evaluation of markers RANKL-OPG-Interleukin in crevicular gingival fluid (FGC) Obtaining and handling of samples FGC
FGC samples were obtained from six sites periodontal 3 vestibular and 3 palatal / lingual (average mesial - distal) undergoing teeth whitening. Samples were taken before the whitening (baseline) and after each whitening session, a week and a month post-whitening.
For this were used Periopaper® absorbent paper strips (OraFlow Inc., New York, NY, USA). The teeth were isolated from a relative fashion using cotton rolls, once isolated with a Gracey 3/4 the supra-gingival plaque be removed and gently the surface of the triple air dry syringe. The paper strip was introduced into the selected tooth gingival sulcus until mild resistance tissue and held for 30 seconds. Then they were placed in properly labeled Eppendorf tubes and transported immediately to be stored at -80 ° C until the centrifugal elution process. The paper strips contaminated with saliva or blood were discarded.
The paper strips were subjected to centrifugal elution to obtain total proteins present in the FGC. To do this, incubated for 30 minutes in 100 .mu.l of elution buffer containing 0.05% Tween in Tris-HCl pH 7.4 (Fluka, Sigma-Aldrich Chemie GmbH, Buchs, Switzerland) and then centrifugarnn 10,000 xg for 5 minutes at 4 ° C. The process of centrifugal circumvention repetio 3 times to a final volume of 300 ul, which was stored at -80 ° C until analysis.
Evaluation of markers RANKL-OPG-Interleukin in crevicular gingival fluid (FGC) Total proteins were quantified by the Bradford ® system (R \& D Systems Inc., Minneapolis, MN, USA) and from 50 ul of sample eluted from medieronn levels of RANKL, OPG and interleukin by ELISA (Quantikine®; R \& D Systems Inc. ) following the manufacturer's protocol. The average absorbance at 492 nm with correction at 630 nm using an automated plate reader (Universal ELx800 Microplate Reader, Bio-Tek Instruments Inc., Winooski, VT, USA). The concentration of the markers in each sample was calculated using an equation of the line of 4th grade.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH | Experimental | Other: Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA)Hydrogen peroxide 35% to intracoronal bleaching in discoloration teeth eith endodontic treatment |
| PC | Experimental | Other: carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).Carbamide peroxide 37% to intracoronal bleaching in discoloration teeth eith endodontic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA)Also: Hp 35%bleaching teeth gel to intracameral use. | Other | PH |
| carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).Also: Cp 37%bleaching teeth gel to intracameral use. | Other | PC |
Primary outcome
Bone destruction markers in gingival fluids
Time frame: 1 year
[Interleukin 1b , RANK-L, OPG ] (pg/ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Derived from this study: PubMed 40667613Miranda 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.
- Derived from this study: PubMed 30132252Bersezio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
eduardo fernandez principal investigator
University of Chile
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA) and carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil). in people with Discolored Teeth, run by University of Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone destruction markers in gingival fluids (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02718183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.