Analysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth

• ClinicalTrials.gov Identifier: NCT04548674
• Recruitment Status: Completed
• First Posted: September 14, 2020
• Last Update Posted: September 14, 2020
• Sponsor: Universidade Federal do Para
• Information provided by (Responsible Party): Cecy Martins Silva, Universidade Federal do Para

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%).

Condition or disease	Intervention/treatment	Phase
Pulp Inflammation	Other: Whiteness HP 35%; Device: Whiteness HP 35% + LASER; Other: Whiteness HP 35% + CPP; Other: Whiteness HP 35% + NANO	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Different Desensitizing Protocols on the Pulp Inflammatory Response in Bleached Teeth: A Randomized Clinical Trial.
• Actual Study Start Date: August 20, 2018
• Actual Primary Completion Date: March 15, 2019
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Positive Control Group; Whiteness HP 35%	Other: Whiteness HP 35%; Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm
Experimental: Laser Group; Whiteness HP 35% + Laser	Other: Whiteness HP 35%; Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm; Device: Whiteness HP 35% + LASER; 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.
Experimental: CPP Group; Whiteness HP 35% + CPP	Other: Whiteness HP 35%; Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm; Other: Whiteness HP 35% + CPP; 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.
Experimental: Nano Group; Whiteness HP 35% + NANO	Other: Whiteness HP 35%; Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm; Other: Whiteness HP 35% + NANO; 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.
No Intervention: Negative Control; Without intervention

Outcome Measures

Primary Outcome Measures :

1. Pulp inflammation [ Time Frame: 3 days After extraction of third molars ]
   Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 26 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Brazil

Universidade Federal do Pará

Belém, Pará, Brazil, 66075-110

Sponsors and Collaborators

Universidade Federal do Para

More Information

• Responsible Party: Cecy Martins Silva, Professor Clínico, Universidade Federal do Para
• ClinicalTrials.gov Identifier: NCT04548674
• Other Study ID Numbers: UFPara-008
• First Posted: September 14, 2020
• Last Update Posted: September 14, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cecy Martins Silva, Universidade Federal do Para:

Therapies; Caspase 3; Immunohistochemistry

Additional relevant MeSH terms:

Inflammation; Pathologic Processes