Tooth HypersensitivityPhase 4NCT06358911
A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability
A Phase 4 study testing Poly amido amine dendrimer (PAMAM), Manufacturer's desensitizing agent, Ultra EZ and MI paste plus, desensitizing agent in people with Tooth Hypersensitivity, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Hypersensitivity
- What is being tested?
- Poly amido amine dendrimer (PAMAM), Manufacturer's desensitizing agent, Ultra EZ and MI paste plus, desensitizing agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Nov 2021to 10 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry - Ain Shams University
Cairo, El Weili, 4393005
About this study
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.
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.
Read the 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
- Being tested
- Poly amido amine dendrimer (PAMAM), Manufacturer's desensitizing agent, Ultra EZ, MI paste plus, desensitizing agent, Hydroxyapatite and F (ReminPro), desensitizing agent
- Keywords
- Dental Bleaching, Shade Stability
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Manufacturer's desensitizing agent, Ultra EZOther
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 agentOther
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 agentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Hydroxyapatite and F (ReminPro), desensitizing agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start13 Nov 2021
- Primary completion5 Aug 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farid MS Al Askary, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358911
- Sponsor's protocol ID
- FDASU-RecID022001
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06358911
- Acronym / sponsor ID
- FDASU-RecID022001
- Conditions
- Tooth Hypersensitivity
- Keywords
- Dental Bleaching, Shade Stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Poly amido amine dendrimer (PAMAM)'s desensitizing agent | Experimental | Other: Poly amido amine dendrimer (PAMAM)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 |
| Manufacturer's desensitizing agent, Ultra EZ | Experimental | Other: Manufacturer's desensitizing agent, Ultra EZ3% potassium nitrate and 0.11% fluoride (Ultra EZ), gel The application of manufacturer recommended desensitizing agent for 1hrs |
| MI paste plus, desensitizing agent | Experimental | Other: MI paste plus, desensitizing agentCasein-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 |
| Hydroxyapatite and F (ReminPro), desensitizing agent | Experimental | Other: Hydroxyapatite and F (ReminPro), desensitizing agentHydroxyapatite, Fluoride and Xylitol, water-based cream The application of Hydroxyapatite and F (ReminPro) according to manufacturer instructions, 3minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Poly amido amine dendrimer (PAMAM)'s desensitizing agent |
| Manufacturer's desensitizing agent, Ultra EZDesensitizing 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. | Other | Manufacturer's desensitizing agent, Ultra EZ |
| MI paste plus, desensitizing agentDesensitizing 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. | Other | MI paste plus, desensitizing agent |
| Hydroxyapatite and F (ReminPro), desensitizing agentDesensitizing 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 | Other | Hydroxyapatite and F (ReminPro), desensitizing agent |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farid MS Al Askary, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poly amido amine dendrimer (PAMAM), Manufacturer's desensitizing agent, Ultra EZ and MI paste plus, desensitizing agent in people with Tooth Hypersensitivity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.