Pulp InflammationNCT04548674
Analysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth
A study testing Whiteness HP 35%, Whiteness HP 35% + LASER and Whiteness HP 35% + CPP in people with Pulp Inflammation, run by Universidade Federal do Para at 1 site in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Inflammation
- What is being tested?
- Whiteness HP 35%, Whiteness HP 35% + LASER and Whiteness HP 35% + CPP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2018to 30 Jun 2019
- 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 20 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Desensitizing Protocols on the Pulp Inflammatory Response in Bleached Teeth: A Randomized Clinical Trial.
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.
- Conditions
- Pulp Inflammation
- Being tested
- Whiteness HP 35%, Whiteness HP 35% + LASER, Whiteness HP 35% + CPP, Whiteness HP 35% + NANO
- Keywords
- Therapies, Caspase 3, Immunohistochemistry
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whiteness HP 35%Other
Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm
Whiteness HP 35% + LASERDevice
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.
Whiteness HP 35% + CPPOther
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.
Whiteness HP 35% + NANOOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Control Group | Placebo comparator | Whiteness HP 35% Receives: Other: Whiteness HP 35% |
| Laser Group | Experimental | Whiteness HP 35% + Laser Receives: Other: Whiteness HP 35%; Device: Whiteness HP 35% + LASER |
| CPP Group | Experimental | Whiteness HP 35% + CPP Receives: Other: Whiteness HP 35%; Other: Whiteness HP 35% + CPP |
| Nano Group | Experimental | Whiteness HP 35% + NANO Receives: Other: Whiteness HP 35%; Other: Whiteness HP 35% + NANO |
| Negative Control | No intervention | Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp inflammation
Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not
Measured: 3 days After extraction of third molars
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start20 Aug 2018
- Primary completion15 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp InflammationStudies 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548674
- Sponsor's protocol ID
- UFPara-008
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Desensitizing Protocols on the Pulp Inflammatory Response in Bleached Teeth: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04548674
- Acronym / sponsor ID
- UFPara-008
- Conditions
- Pulp Inflammation
- Keywords
- Therapies, Caspase 3, Immunohistochemistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Sep 2020 (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.
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%).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Positive Control Group | Placebo comparator | Other: Whiteness HP 35%Whiteness HP 35% |
| Laser Group | Experimental | Other: Whiteness HP 35%, Device: Whiteness HP 35% + LASERWhiteness HP 35% + Laser |
| CPP Group | Experimental | Other: Whiteness HP 35%, Other: Whiteness HP 35% + CPPWhiteness HP 35% + CPP |
| Nano Group | Experimental | Other: Whiteness HP 35%, Other: Whiteness HP 35% + NANOWhiteness HP 35% + NANO |
| Negative Control | No intervention | –Without intervention |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Whiteness HP 35%Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm | Other | CPP Group, Laser Group, Nano Group, Positive Control Group |
| Whiteness HP 35% + LASERA 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. | Device | Laser Group |
| Whiteness HP 35% + CPPTopical 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. | Other | CPP Group |
| Whiteness HP 35% + NANOA 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. | Other | Nano Group |
Primary outcome
Pulp inflammation
Time frame: 3 days After extraction of third molars
Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not
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 14 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whiteness HP 35%, Whiteness HP 35% + LASER and Whiteness HP 35% + CPP in people with Pulp Inflammation, run by Universidade Federal do Para 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 6 inclusion and 4 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 14 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
Pulp inflammation (time frame: 3 days After extraction of third molars). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2020.