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

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%).

Study Overview

• Status: Completed
• Conditions: Pulp Inflammation
• Intervention / Treatment: Other: Whiteness HP 35%; Device: Whiteness HP 35% + LASER; Other: Whiteness HP 35% + CPP; Other: Whiteness HP 35% + NANO

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pará
    • Belém, Pará, Brazil, 66075-110
      • Universidade Federal do Pará

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 26 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulp inflammation	Evaluation of pulp inflammation through immunohistochemistry of the third molar whitening or not	3 days After extraction of third molars

Collaborators and Investigators

• Sponsor: Universidade Federal do Para

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2018
• Primary Completion (ACTUAL): March 15, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Immunohistochemistry; Therapies; Caspase 3
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: UFPara-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No