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

Pulp Inflammation Clinical Trial

Official title:

Effect of Different Desensitizing Protocols on the Pulp Inflammatory Response in Bleached Teeth: A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548674
• Other study ID #: UFPara-008
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2020
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pulp Inflammation

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Pará	Belém	Pará

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulp inflammation	Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not	3 days After extraction of third molars