A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability

Tooth Hypersensitivity Clinical Trial

Official title:

A Clinical Study for the Effect of 4th Generation Poly Amido Amine Dendrimer (PAMAM-COOH) Desensitizing Agent on Post-Bleaching Hypersensitivity and Shade Stability of Patients Subjected to Bleaching Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06358911
• Other study ID #: FDASU-RecID022001
• Status: Completed
• Phase: Phase 4
• Start date: November 13, 2021
• Est. completion date: September 10, 2023

Study information

• Verified date: April 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assessed the impact of four desensitizing agents on both color stability and dental sensitivity following a bleaching procedure, spanning from the 24-hour to the 1-year follow-up assessment periods.

Description:

Dental bleaching is a temporary treatment with potential adverse effects on dental sensitivity post-procedure. Therefore, the study aimed to evaluate dental color stability and sensitivity over a one-year period following bleaching, utilizing one of four desensitizing agents: PAMAM, MI Paste Plus, Hydroxyapatite and F (ReminPro), and Ultra EZ. The selection of the desensitizing agent was based on a predetermined randomization sequence generated in Microsoft Excel. Color stability was objectively assessed through spectrophotometric analysis, while subjective evaluation was conducted using the Vita Classic shade guide by two external observers not involved in the procedure. Dental sensitivity levels were tracked at various intervals using a visual analogue scale. Baseline measurements for both sensitivity and color stability were taken before the bleaching procedure, with subsequent evaluations at 24 hours, 3 days, 1 week, 1 month, 3 months, 6 months, 9 months, and 1 year post-bleaching. The study involved 60 patients from Ain Shams University seeking dental whitening treatment, divided into four groups based on the randomization sequence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 10, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Male and female patients will be selected according to the following inclusion criteria:

• Participants should have their entire upper and lower teeth, from right first premolar to left first premolar, present and sound, without restorations or periodontal disease.
• Teeth have never been bleached before.
• The participants are required to have low-caries index.
• Teeth should have a Vita-color shade of A2 or darker.
• Cooperative behavior patient and medically free.
• Patient ages between 18 to 40 years old.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Hypersensitivity

Intervention

Other:
• Poly amido amine dendrimer (PAMAM)
Desensitizing agents was applied once after the bleaching procedure,as follows: 1-Bleaching/PAMAM group, patients received bleaching followed by the application of PAMAM for 30 minutes according to previous studies.
• Manufacturer's desensitizing agent, Ultra EZ
Desensitizing agents was applied once after the bleaching procedure, as follows: 2-Control group, where patients received hydrogen peroxide in-office bleaching followed by the application of manufacturer recommended desensitizing agent ( Ultra EZ) once for 60 minutes.
• MI paste plus, desensitizing agent
Desensitizing agents was applied once after the bleaching procedure, as follows: 3-Bleaching/MI Paste Plus group, patients received bleaching followed by the application of MI paste plus according to the manufacturer's instructions once for 3 minutes.
• Hydroxyapatite and F (ReminPro), desensitizing agent
Desensitizing agents was applied once after the bleaching procedure, as follows: 4-Bleaching/Hydroxyapatite and F (ReminPro), patients received bleaching followed by the application of Hydroxyapatite and F (ReminPro) according to the manufacturer's instructions once for 3 minutes

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry - Ain Shams University	Cairo	El Weili

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-bleaching dental hypersensitivity	Assessment will be carried out by a visual analogue scale (VAS), from 0 (no tooth sensitivity at all) to 10 (intolerable pain). Air blast stimulus will be used and will be applied on the tooth at distance of 0.5-1 cm for 2 seconds by the maximum power of the compressed air jet from the dental unit. Then sensitivity was measured before bleaching (baseline) and at each follow up period, 24 hours, 3 days, 7 days, 3 months, 6 months, 9 months, and one year post treatment	24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment
Primary	Shade stability	Assesment 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 the clinic lights with the dental unit light 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 assesment was carried out before bleaching and at each follow up periods, 24 hours, 3 days, 7 days, 3 months, 6 months, 9 months, and one year post treatment	24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment