Clinical trial NCT06358911: A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Hypersensitivity
Keywords: Dental Bleaching
Shade Stability
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-bleaching dental hypersensitivity
timeFrame: 24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment
measure: Shade stability
timeFrame: 24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Ain Shams University
state: El Weili
Study officials:
affiliation: Ain Shams University
name: Farid MS Al Askary, Professor
role: STUDY_DIRECTOR
References: