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

NCT ID: NCT06358911

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-13
• Study Completion Date: 2023-09-10

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.

Detailed 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.

Conditions

Tooth Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Poly amido amine dendrimer (PAMAM)'s desensitizing agent

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

Group Type: EXPERIMENTAL

Poly amido amine dendrimer (PAMAM)

Intervention Type: 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.

Manufacturer's desensitizing agent, Ultra EZ

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

Group Type: EXPERIMENTAL

Manufacturer's desensitizing agent, Ultra EZ

Intervention Type: 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.

MI paste plus, desensitizing agent

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

Group Type: EXPERIMENTAL

MI paste plus, desensitizing agent

Intervention Type: 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.

Hydroxyapatite and F (ReminPro), desensitizing agent

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

Group Type: EXPERIMENTAL

Hydroxyapatite and F (ReminPro), desensitizing agent

Intervention Type: 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

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farid MS Al Askary, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Faculty of Dentistry - Ain Shams University

Cairo, El Weili, Egypt

Countries

Egypt

Other Identifiers

FDASU-RecID022001

Identifier Type: -

Identifier Source: org_study_id