SatisfactionNCT03194984
Effectiveness of Office Bleaching Agents in Patients of Different Age Group
A study testing Hydrogen peroxide 35% and Hydrogen peroxide 38% in people with Satisfaction, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute risk and intensity of dentin sensitivity due to dental bleaching in the office with 35% hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent, South Jordan, UT, USA) in the same arch in patients… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Satisfaction
- What is being tested?
- Hydrogen peroxide 35% and Hydrogen peroxide 38%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 15 May 2017to 30 Jan 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age up to 25 years
- Patients aged 40 years up to 65 years
- Good oral and general health
- Teeth free of restorations or with small restorations
- Free from carious injury,
- Patients with tooth color A2 or darker according to the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany)
- Agree to the informed consent form
Who cannot join
- extensive restoration
- Patients who have already undergone dental whitening
- Pregnant or lactating women
- That report dental sensitivity
- With non-carious cervical lesion
- Parafunctional habits
Show all 9Show fewer
- Orthodontic appliances
- Any other type of oral pathology
- Smokers, patients who are using analgesic or anti-inflammatory drugs, present systemic alterations such as gastric, cardiac, renal and hepatic problems, diabetics, hypertensives or pre-existing neoplasias.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Gisele Rodrigues da Silva
Uberlândia, Av Pará S/n Bloco 4 L Anexo A Sala 42 Campus Umuarama
About this study
Official title: Randomized Clinical Trial Comparing the Effectiveness of Office Bleaching Agents in Patients of Different Age Group
To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute risk and intensity of dentin sensitivity due to dental bleaching in the office with 35% hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent, South Jordan, UT, USA) in the same arch in patients of different age groups: 18 to 25 years and 40 to 65 years. Data will be collected, tabulated and submitted to statistical analysis
Read the detailed description
Throughout life, the aging of the human being as a whole is inevitable. The dental structure such as cementum and dentin undergo some changes over time, such as secondary deposition of dentin, which results in the reduction of root canal length. In addition, with aging the teeth undergo color changes, presenting a more yellowish or grayish coloration (Ravindra SV et al., 2015). The fact is that most of the studies that involve the technique of dental bleaching have as inclusion factor only young adult patients, excluding patients of more advanced age groups. Therefore, it is fundamental to evaluate the whitening technique in these older patients, since it is a treatment that does not cause harm to the individuals To assess the effect of dental bleaching in the office with Whiteness HP Automixx, FGM at 35% and Opalescence Boost at 38% in the same arch, in different age groups (18 to 25 years and 40 to 65 years) in absolute risk and intensity Of the postoperative dental sensitivity through the visual analog (VAS 0-10) and analogue (NRS 0-4) scales.
- Evaluate the efficacy of Whitening HP Automixx, FGM 35% and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years) using Color Vita Classical and Vita Bleachedguide, and the Vita Easyshade spectrophotometer.
- Evaluate the satisfaction of patients after Whitening HP Automixx at 35, FGM and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years).
- Conditions
- Satisfaction
- Being tested
- Hydrogen peroxide 35%, Hydrogen peroxide 38%
- Keywords
- dental whitening, Dental office whitening
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen peroxide 35%Drug
Also called Hydrogen peroxide 38%
The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.
Hydrogen peroxide 38%Drug
Also called Hydrogen peroxide 35%
The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.
| Study group | Role | What they receive |
|---|---|---|
| Young Patient | Other | With 18-25 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38% Receives: Drug: Hydrogen peroxide 35%; Drug: Hydrogen peroxide 38% |
| Adult Patient | Other | With 40-65 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38% Receives: Drug: Hydrogen peroxide 35%; Drug: Hydrogen peroxide 38% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth discoloration
Efficacy of office dental whitening mensured by Easyshade spectrophotometer.
Measured: 36 weeks
Secondary outcomes (2)
Dentin sensitivity
It will analised the risk and intensity of tooth sensitivity of dental bleaching
Measured: 36 weeks
Patient satisfaction
It will analised the patient satisfaction by questionnaire of self-perception of aesthetics (PIDAQ)
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start15 May 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SatisfactionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- range of patients aged 18 to 25 years receiving two types of geis and range of patients aged 40-65 years receiving two types of geis
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Gisele Rodrigues da Silva, Federal University of Uberlandia
- Investigators
- Gisele Silva, Dra, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194984
- Sponsor's protocol ID
- CAAE: 57252216.2.0000.5152
- Status last verified
- Feb 2018
- First submitted
- 23 May 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Geus JL, Wambier LM, Kossatz S, Loguercio AD, Reis A. At-home vs In-office Bleaching: A Systematic Review and Meta-analysis. Oper Dent. 2016 Jul-Aug;41(4):341-56. doi: 10.2341/15-287-LIT. Epub 2016 Apr 5.
PubMed 27045285Kossatz S, Dalanhol AP, Cunha T, Loguercio A, Reis A. Effect of light activation on tooth sensitivity after in-office bleaching. Oper Dent. 2011 May-Jun;36(3):251-7. doi: 10.2341/10-289-C. Epub 2011 Jul 8.
PubMed 21740236Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
PubMed 21488723Martin J, Rivas V, Vildosola P, Moncada L, Oliveira Junior OB, Saad JR, Fernandez E, Moncada G. Personality Style in Patients Looking for Tooth Bleaching and Its Correlation with Treatment Satisfaction. Braz Dent J. 2016 Jan-Feb;27(1):60-5. doi: 10.1590/0103-6440201600127.
PubMed 27007348
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the Effectiveness of Office Bleaching Agents in Patients of Different Age Group
- ClinicalTrials.gov ID
- NCT03194984
- Acronym / sponsor ID
- CAAE: 57252216.2.0000.5152
- Conditions
- Satisfaction
- Keywords
- dental whitening, Dental office whitening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- 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.
To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute risk and intensity of dentin sensitivity due to dental bleaching in the office with 35% hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent, South Jordan, UT, USA) in the same arch in patients of different age groups: 18 to 25 years and 40 to 65 years. Data will be collected, tabulated and submitted to statistical analysis
Detailed description
Throughout life, the aging of the human being as a whole is inevitable. The dental structure such as cementum and dentin undergo some changes over time, such as secondary deposition of dentin, which results in the reduction of root canal length. In addition, with aging the teeth undergo color changes, presenting a more yellowish or grayish coloration (Ravindra SV et al., 2015). The fact is that most of the studies that involve the technique of dental bleaching have as inclusion factor only young adult patients, excluding patients of more advanced age groups. Therefore, it is fundamental to evaluate the whitening technique in these older patients, since it is a treatment that does not cause harm to the individuals To assess the effect of dental bleaching in the office with Whiteness HP Automixx, FGM at 35% and Opalescence Boost at 38% in the same arch, in different age groups (18 to 25 years and 40 to 65 years) in absolute risk and intensity Of the postoperative dental sensitivity through the visual analog (VAS 0-10) and analogue (NRS 0-4) scales.
- Evaluate the efficacy of Whitening HP Automixx, FGM 35% and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years) using Color Vita Classical and Vita Bleachedguide, and the Vita Easyshade spectrophotometer.
- Evaluate the satisfaction of patients after Whitening HP Automixx at 35, FGM and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- range of patients aged 18 to 25 years receiving two types of geis and range of patients aged 40-65 years receiving two types of geis
| Arm | Type | Receives |
|---|---|---|
| Young Patient | Other | Drug: Hydrogen peroxide 35%, Drug: Hydrogen peroxide 38%With 18-25 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38% |
| Adult Patient | Other | Drug: Hydrogen peroxide 35%, Drug: Hydrogen peroxide 38%With 40-65 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years of age up to 25 years
- Patients aged 40 years up to 65 years
- Good oral and general health
- Teeth free of restorations or with small restorations
- Free from carious injury,
Key exclusion criteria (9 listed)
- extensive restoration
- Patients who have already undergone dental whitening
- Pregnant or lactating women
- That report dental sensitivity
- With non-carious cervical lesion
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%Also: Hydrogen peroxide 38%The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions. | Drug | Adult Patient, Young Patient |
| Hydrogen peroxide 38%Also: Hydrogen peroxide 35%The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions. | Drug | Adult Patient, Young Patient |
Primary outcome
Tooth discoloration
Time frame: 36 weeks
Efficacy of office dental whitening mensured by Easyshade spectrophotometer.
2 secondary outcomes
Dentin sensitivity
Time frame: 36 weeks
Patient satisfaction
Time frame: 36 weeks
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 13 Feb 2018.
- Background: PubMed 27045285de Geus JL, Wambier LM, Kossatz S, Loguercio AD, Reis A. At-home vs In-office Bleaching: A Systematic Review and Meta-analysis. Oper Dent. 2016 Jul-Aug;41(4):341-56. doi: 10.2341/15-287-LIT. Epub 2016 Apr 5.
- Background: PubMed 21740236Kossatz S, Dalanhol AP, Cunha T, Loguercio A, Reis A. Effect of light activation on tooth sensitivity after in-office bleaching. Oper Dent. 2011 May-Jun;36(3):251-7. doi: 10.2341/10-289-C. Epub 2011 Jul 8.
- Background: PubMed 21488723Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
- Background: PubMed 27007348Martin J, Rivas V, Vildosola P, Moncada L, Oliveira Junior OB, Saad JR, Fernandez E, Moncada G. Personality Style in Patients Looking for Tooth Bleaching and Its Correlation with Treatment Satisfaction. Braz Dent J. 2016 Jan-Feb;27(1):60-5. doi: 10.1590/0103-6440201600127.
- 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.
Gisele Silva, Dra principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen peroxide 35% and Hydrogen peroxide 38% in people with Satisfaction, run by Federal University of Uberlandia at 1 site in Brazil.
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 7 inclusion and 9 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Tooth discoloration (time frame: 36 weeks). 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 NCT03194984, which also lists 4 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 13 Feb 2018.