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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Tooth Hypersensitivity

Treatments: Other: Hydroxyapatite and F (ReminPro), desensitizing agent; Other: Poly amido amine dendrimer (PAMAM); Other: MI paste plus, desensitizing agent; Other: Manufacturer's desensitizing agent, Ultra EZ

Study type: Interventional

Funder types: Other

Identifiers

NCT06358911

FDASU-RecID022001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Poly amido amine dendrimer (PAMAM)'s desensitizing agent

Experimental group

Description:

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

Treatment:

Other: Poly amido amine dendrimer (PAMAM)

Manufacturer's desensitizing agent, Ultra EZ

Experimental group

Description:

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

Treatment:

Other: Manufacturer's desensitizing agent, Ultra EZ

MI paste plus, desensitizing agent

Experimental group

Description:

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

Treatment:

Other: MI paste plus, desensitizing agent

Hydroxyapatite and F (ReminPro), desensitizing agent

Experimental group

Description:

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

Treatment:

Other: Hydroxyapatite and F (ReminPro), desensitizing agent