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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Post-bleaching dental hypersensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Poly amido amine dendrimer (PAMAM) (Other)
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
Intervention: Manufacturer's desensitizing agent, Ultra EZ (Other)
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
Intervention: MI paste plus, desensitizing agent (Other)
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
Intervention: Hydroxyapatite and F (ReminPro), desensitizing agent (Other)
Outcomes
Primary Outcomes
Post-bleaching dental hypersensitivity
Time Frame: 24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment
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
Shade stability
Time Frame: 24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment
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
Secondary Outcomes
No secondary outcomes reported