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

NCT ID: NCT04548674

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2019-06-30

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.

Conditions

Pulp Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Positive Control Group

Whiteness HP 35%

Group Type: PLACEBO_COMPARATOR

Whiteness HP 35%

Intervention Type: OTHER

Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm

Laser Group

Whiteness HP 35% + Laser

Group Type: EXPERIMENTAL

Whiteness HP 35%

Intervention Type: OTHER

Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm

Whiteness HP 35% + LASER

Intervention Type: DEVICE

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.

CPP Group

Whiteness HP 35% + CPP

Group Type: EXPERIMENTAL

Whiteness HP 35%

Intervention Type: OTHER

Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm

Whiteness HP 35% + CPP

Intervention Type: OTHER

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.

Nano Group

Whiteness HP 35% + NANO

Group Type: EXPERIMENTAL

Whiteness HP 35%

Intervention Type: OTHER

Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm

Whiteness HP 35% + NANO

Intervention Type: OTHER

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.

Negative Control

Without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Whiteness HP 35%

Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm

Intervention Type: OTHER

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Professor Clínico

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal do Pará

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-008

Identifier Type: -

Identifier Source: org_study_id