Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability

NCT06358924 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RecID032004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year.

Conditions

Tooth Hypersensitivity

Keywords

Dental Bleaching; Shade Stability

Outcome Measures

Primary Outcomes (2)

• Post-bleaching hypersensitivity

  Assessment was carried out by a visual analogue scale (VAS), from 0 (no tooth sensitivity at all) to 10 (intolerable pain). The air stimulus was applied at a distance of 0.5-1 cm for 2 seconds by the maximum power of the compressed air jet from the dental unit. Then patients were asked to describe the intensity of pain by numbers from 1 to 10. Sensitivity was measured before bleaching (baseline) and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.

  24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching

• Shade stability

  Assessment was carried out using Vita Easy-Shade V. Two measurements were taken for each tooth from the upper right canine to the upper left canine, and same for the lower arch. For light condition standardization, all shade measurements were carried out under natural daylight in combination with constant artificial light sources; the clinic overhead lights in combination with the dental unit light directed away from the patient. The shade of each tooth was recorded as well as the values of L, a, and b. The shade of the upper two centrals was confirmed using Vita classical shade guide. Shade assessment was carried out before bleaching, and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.

  24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching

Study Arms (4)

After whitening mousse

EXPERIMENTAL

30 % Xylitol, 4.2 % potassium nitrate, and 1450 ppm fluoride. Topical tooth gel Gel was applied on bleached teeth for 10 minutes according to manufacturer's instructions.

Other: Potassium nitrate with fluoride

Mi Paste Plus

EXPERIMENTAL

Casein-phosphopeptide-amorphous calcium phosphate with 0.2 % sodium fluoride (900ppm) Topical tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions

Other: Casein phosphopeptide-amorphous calcium phosphate with fluoride

Hydroxyapatite and Fluoride (ReminPro)

EXPERIMENTAL

Hydroxyapatite (calcium and phosphate), ethanolic colophony, fluoride (1450 ppm NaF) and xylitol Topical water based tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions

Other: Hydroxyapatite with fluoride

PAMAM "poly (amido amine)" dendrimer

EXPERIMENTAL

PAMAM-succinamic acid dendrimer, 1,4-diaminobutane core, generation 4 solution. 10 wt.% in water Colorless liquid The liquid was applied on bleached teeth for 30 minutes (according to previous studies)

Other: PAMAM-carboxylic acid dendrimer

Interventions

Potassium nitrate with fluoride OTHER

Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of the desensitizing agent recommended by the manufacturer (After Whitening Mousse), once for 10 minutes.

After whitening mousse

Casein phosphopeptide-amorphous calcium phosphate with fluoride OTHER

Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Mi Paste Plus once for 3 minutes.

Mi Paste Plus

Hydroxyapatite with fluoride OTHER

Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Hydroxyapatite and Fluoride (ReminPro) once for 3 minutes.

Hydroxyapatite and Fluoride (ReminPro)

PAMAM-carboxylic acid dendrimer OTHER

Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of PAMAM once for 30 minutes.

PAMAM "poly (amido amine)" dendrimer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants with their entire upper and lower teeth, from right first premolar to left first premolar, present and sound, without restorations or periodontal disease.
• The participants had low-caries index scores.
• Participants had teeth with a Vita-color shade of A2 or darker.
• Cooperative behavior patient and medically free.
• Patient ages between 18 to 40 years old

You may not qualify if:

• Serious medically compromised patients.
• Smoking, alcoholism.
• Hypersensitivity to the agents used in the study.
• Lactating, pregnant patients.
• Patients with serious oral diseases, as acute necrotizing gingivitis, acute gingiva stomatitis, or those undergoing orthodontic treatment.
• Patients with dental enamel cracks.
• Patients who've had previous bleaching treatments

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, El Weilli, 4393005, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

potassium nitrate; Fluorides; Durapatite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Calcium Compounds; Minerals; Phosphorus Compounds

Study Officials

• Farid MS El-Askary, Professor

  Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This clinical trial was double blinded trial in which both the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also the outcome assessors were blinded to the treatment that each participant had received.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical study was conducted to evaluate the effect of using different desensitizing agents: 1. As recommended by manufacturer 2. Casein phosphopeptide-amorphous calcium phosphate/fluoride (CPP-ACPF) containing desensitizing agent 3. Hydroxyapatite/fluoride/xylitol containing desensitizing agent 4. Poly (amido amine) dendrimer with carboxylic acid terminal functional group containing desensitizing agent. On patients subjected to bleaching procedure using hydrogen peroxide containing bleaching agent. The clinical evaluation included: 1. Post-bleaching hypersensitivity. 2. Post-bleaching long-term shade stability.

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: November 13, 2021
• Primary Completion: August 25, 2023
• Study Completion: September 20, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)