Back to resultsAnalysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth
Primary Purpose
Pulp Inflammation
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Whiteness HP 35%
Whiteness HP 35% + LASER
Whiteness HP 35% + CPP
Whiteness HP 35% + NANO
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Inflammation focused on measuring Therapies, Caspase 3, Immunohistochemistry
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
- Universidade Federal do Pará
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
No Intervention
Arm Label
Positive Control Group
Laser Group
CPP Group
Nano Group
Negative Control
Arm Description
Whiteness HP 35%
Whiteness HP 35% + Laser
Whiteness HP 35% + CPP
Whiteness HP 35% + NANO
Without intervention
Outcomes
Primary Outcome Measures
Pulp inflammation
Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not
Secondary Outcome Measures
Full Information
NCT ID
NCT04548674
First Posted
September 1, 2020
Last Updated
September 8, 2020
Sponsor
Universidade Federal do Para
1. Study Identification
Unique Protocol Identification Number
NCT04548674
Brief Title
Analysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth
Official Title
Effect of Different Desensitizing Protocols on the Pulp Inflammatory Response in Bleached Teeth: A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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%).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Inflammation
Keywords
Therapies, Caspase 3, Immunohistochemistry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive Control Group
Arm Type
Placebo Comparator
Arm Description
Whiteness HP 35%
Arm Title
Laser Group
Arm Type
Experimental
Arm Description
Whiteness HP 35% + Laser
Arm Title
CPP Group
Arm Type
Experimental
Arm Description
Whiteness HP 35% + CPP
Arm Title
Nano Group
Arm Type
Experimental
Arm Description
Whiteness HP 35% + NANO
Arm Title
Negative Control
Arm Type
No Intervention
Arm Description
Without intervention
Intervention Type
Other
Intervention Name(s)
Whiteness HP 35%
Intervention Description
Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm
Intervention Type
Device
Intervention Name(s)
Whiteness HP 35% + LASER
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Whiteness HP 35% + CPP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Whiteness HP 35% + NANO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulp inflammation
Description
Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not
Time Frame
3 days After extraction of third molars
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
Facility Information:
Facility Name
Universidade Federal do Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66075-110
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Analysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth
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