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

NCT06358911 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RecID022001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Hypersensitivity

Keywords

Dental Bleaching; Shade Stability

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

Poly amido amine dendrimer (PAMAM)'s desensitizing agent

EXPERIMENTAL

Fourth generation with COOH terminal functional group, colorless liquid. PAMAM-succinamic acid dendrimer, 1,4-diaminobutane core, generation 4 solution. 10 wt.% in water. The application of PAMAM 30 min according to previous studies

Other: Poly amido amine dendrimer (PAMAM)

Manufacturer's desensitizing agent, Ultra EZ

EXPERIMENTAL

3% potassium nitrate and 0.11% fluoride (Ultra EZ), gel The application of manufacturer recommended desensitizing agent for 1hrs

Other: Manufacturer's desensitizing agent, Ultra EZ

MI paste plus, desensitizing agent

EXPERIMENTAL

Casein-phosphopeptide-amorphous calcium phosphate with Fluoride, topical tooth cream. Gel contains pure water,D-sorbitol,glycerol,Carboxymethylcellulose Sodium, casein phosphopeptide amorphous calcium phosphate,propylene glycol, titanium dioxide, Silicon dioxide, Sodium Saccharin,Phosphoric acid, butyl P-hydroxy-benzoate, and ethyl hydroxyl benzoate The application of MI paste plus according to manufacturer instructions, 3minutes

Other: MI paste plus, desensitizing agent

Hydroxyapatite and F (ReminPro), desensitizing agent

EXPERIMENTAL

Hydroxyapatite, Fluoride and Xylitol, water-based cream The application of Hydroxyapatite and F (ReminPro) according to manufacturer instructions, 3minutes

Other: Hydroxyapatite and F (ReminPro), desensitizing agent

Interventions

Poly amido amine dendrimer (PAMAM) OTHER

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.

Poly amido amine dendrimer (PAMAM)'s desensitizing agent

Manufacturer's desensitizing agent, Ultra EZ OTHER

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.

Manufacturer's desensitizing agent, Ultra EZ

MI paste plus, desensitizing agent OTHER

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.

MI paste plus, desensitizing agent

Hydroxyapatite and F (ReminPro), desensitizing agent OTHER

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

Hydroxyapatite and F (ReminPro), desensitizing agent

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry - Ain Shams University

Cairo, El Weili, 4393005, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Durapatite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Study Officials

• Farid MS Al Askary, Professor

  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 trail was a double blinded trail in which 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 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 will be conducted to evaluate the effect of using 4th generation Poly amido amine dendrimer (PAMAM-COOH) as a desensitizing agent and compared with three different commercially available desensitizing materials: 3% potassium nitrate and 0.11% fluoride (Ultra EZ), as described by manufacturer, Casein-phosphopeptide-amorphous calcium phosphate with F, (MI paste plusTm), and Hydroxyapatite, Fluoride and Xylitol, Hydroxyapatite and F (ReminPro), on: 1. Long-term Post-bleaching hypersensitivity. 2. Long-term Post-bleaching shade stability. For Patients treated with 40% hydrogen-peroxide bleaching agent.

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: November 13, 2021
• Primary Completion: August 5, 2023
• Study Completion: September 10, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)