Tooth HypersensitivityPhase 4NCT06358924
Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability
A Phase 4 study testing Potassium nitrate with fluoride, Casein phosphopeptide-amorphous calcium phosphate with fluoride and Hydroxyapatite with fluoride in people with Tooth Hypersensitivity, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year. 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?
- Potassium nitrate with fluoride, Casein phosphopeptide-amorphous calcium phosphate with fluoride and Hydroxyapatite with fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Nov 2021to 20 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
- Participants with their entire upper and lower teeth, from right first premolar to left first premolar, present and sound, without restorations or periodontal disease.
- The participants had low-caries index scores.
- Participants had teeth with 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.
- Lactating, pregnant patients.
- Patients with serious oral diseases, as acute necrotizing gingivitis, acute gingiva stomatitis, or those undergoing orthodontic treatment.
- Patients with dental enamel cracks.
- Patients who've had previous bleaching treatments
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Ain Shams University
Cairo, El Weilli, 4393005
About this study
Official title: The Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity, Shade Stability and Surface Properties of Bleached Enamel. An In-vitro and In-vivo Study.
This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year.
Read the detailed description
This study was conducted to assess the effectiveness of 4 different desensitizing agents used after dental bleaching regarding dental hypersensitivity and shade stability. It was a double-blinded randomized clinical trial.
The ethical approval was obtained in May 2020 by the Research Ethics Committee an Institutional Review Board, Faculty of Dentistry, Ain Shams University (FDASU-REC).
The number of patients was determined according to G-Power program with a power (1-β error) of 0.8 (Power = 80%), and 95% confidence level (α = 0.05) using a two-sided hypothesis test. According to sample size calculation, 40 patients were needed for this study (n=10 per group).
Patients were selected according to inclusion and exclusion criteria and were randomly assigned into 4 groups according to the desensitizing agent used. The 4 desensitizing agents were: After Whitening Mousse, Mi Paste Plus, Hydroxyapatite and Fluoride (ReminPro) and PAMAM.
Patients signed an informed consent and received a detailed explanation of the study procedures. Baseline dental shade was recorded using Vita Easy-Shade spectrophotometer and Vita Classical Shade guide. Baseline sensitivity was assessed and recorded using a VAS.
All patients received dental bleaching using In-office chemically activated Power Whitening YF (WHITEsmile, Germany) followed by a desensitizing procedure using the desensitizing agent assigned to the specific experimental group.
Dental shade and dental hypersensitivity was assessed at different follow-up appointments; 24-hours, 3 days, 1 week, 1 month, 3 months, 6 months, 9 months and 1 year following the procedures.
Assessment of these variables at follow-up appointments was performed by 2 external assessors, and patients were blinded to the type desensitizing agent used.
- Conditions
- Tooth Hypersensitivity
- Being tested
- Potassium nitrate with fluoride, Casein phosphopeptide-amorphous calcium phosphate with fluoride, Hydroxyapatite with fluoride, PAMAM-carboxylic acid dendrimer
- 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.
Potassium nitrate with fluorideOther
Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of the desensitizing agent recommended by the manufacturer (After Whitening Mousse), once for 10 minutes.
Casein phosphopeptide-amorphous calcium phosphate with fluorideOther
Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Mi Paste Plus once for 3 minutes.
Hydroxyapatite with fluorideOther
Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Hydroxyapatite and Fluoride (ReminPro) once for 3 minutes.
PAMAM-carboxylic acid dendrimerOther
Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of PAMAM once for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| After whitening mousse | Experimental | 30 % Xylitol, 4.2 % potassium nitrate, and 1450 ppm fluoride. Topical tooth gel Gel was applied on bleached teeth for 10 minutes according to manufacturer's instructions. Receives: Other: Potassium nitrate with fluoride |
| Mi Paste Plus | Experimental | Casein-phosphopeptide-amorphous calcium phosphate with 0.2 % sodium fluoride (900ppm) Topical tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions Receives: Other: Casein phosphopeptide-amorphous calcium phosphate with fluoride |
| Hydroxyapatite and Fluoride (ReminPro) | Experimental | Hydroxyapatite (calcium and phosphate), ethanolic colophony, fluoride (1450 ppm NaF) and xylitol Topical water based tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions Receives: Other: Hydroxyapatite with fluoride |
| PAMAM "poly (amido amine)" dendrimer | Experimental | PAMAM-succinamic acid dendrimer, 1,4-diaminobutane core, generation 4 solution. 10 wt.% in water Colorless liquid The liquid was applied on bleached teeth for 30 minutes (according to previous studies) Receives: Other: PAMAM-carboxylic acid dendrimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-bleaching hypersensitivity
Assessment was carried out by a visual analogue scale (VAS), from 0 (no tooth sensitivity at all) to 10 (intolerable pain). The air stimulus was applied at a distance of 0.5-1 cm for 2 seconds by the maximum power of the compressed air jet from the dental unit. Then patients were asked to describe the intensity of pain by numbers from 1 to 10.
Sensitivity was measured before bleaching (baseline) and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.
Measured: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching
Shade stability
Assessment 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 in combination with constant artificial light sources; the clinic overhead lights in combination with the dental unit light directed 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 assessment was carried out before bleaching, and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.
Measured: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching
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 completion25 Aug 2023
- Study completion20 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 was conducted to evaluate the effect of using different desensitizing agents: 1. As recommended by manufacturer 2. Casein phosphopeptide-amorphous calcium phosphate/fluoride (CPP-ACPF) containing desensitizing agent 3. Hydroxyapatite/fluoride/xylitol containing desensitizing agent 4. Poly (amido amine) dendrimer with carboxylic acid terminal functional group containing desensitizing agent. On patients subjected to bleaching procedure using hydrogen peroxide containing bleaching agent. The clinical evaluation included: 1. Post-bleaching hypersensitivity. 2. Post-bleaching long-term shade stability.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farid MS El-Askary, Professor, Study director, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358924
- Sponsor's protocol ID
- FDASU-RecID032004
- 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
- The Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity, Shade Stability and Surface Properties of Bleached Enamel. An In-vitro and In-vivo Study.
- ClinicalTrials.gov ID
- NCT06358924
- Acronym / sponsor ID
- FDASU-RecID032004
- Conditions
- Tooth Hypersensitivity
- Keywords
- Dental Bleaching, Shade Stability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 20 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 compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year.
Detailed description
This study was conducted to assess the effectiveness of 4 different desensitizing agents used after dental bleaching regarding dental hypersensitivity and shade stability. It was a double-blinded randomized clinical trial.
The ethical approval was obtained in May 2020 by the Research Ethics Committee an Institutional Review Board, Faculty of Dentistry, Ain Shams University (FDASU-REC).
The number of patients was determined according to G-Power program with a power (1-β error) of 0.8 (Power = 80%), and 95% confidence level (α = 0.05) using a two-sided hypothesis test. According to sample size calculation, 40 patients were needed for this study (n=10 per group).
Patients were selected according to inclusion and exclusion criteria and were randomly assigned into 4 groups according to the desensitizing agent used. The 4 desensitizing agents were: After Whitening Mousse, Mi Paste Plus, Hydroxyapatite and Fluoride (ReminPro) and PAMAM.
Patients signed an informed consent and received a detailed explanation of the study procedures. Baseline dental shade was recorded using Vita Easy-Shade spectrophotometer and Vita Classical Shade guide. Baseline sensitivity was assessed and recorded using a VAS.
All patients received dental bleaching using In-office chemically activated Power Whitening YF (WHITEsmile, Germany) followed by a desensitizing procedure using the desensitizing agent assigned to the specific experimental group.
Dental shade and dental hypersensitivity was assessed at different follow-up appointments; 24-hours, 3 days, 1 week, 1 month, 3 months, 6 months, 9 months and 1 year following the procedures.
Assessment of these variables at follow-up appointments was performed by 2 external assessors, and patients were blinded to the type desensitizing agent used.
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 was conducted to evaluate the effect of using different desensitizing agents: 1. As recommended by manufacturer 2. Casein phosphopeptide-amorphous calcium phosphate/fluoride (CPP-ACPF) containing desensitizing agent 3. Hydroxyapatite/fluoride/xylitol containing desensitizing agent 4. Poly (amido amine) dendrimer with carboxylic acid terminal functional group containing desensitizing agent. On patients subjected to bleaching procedure using hydrogen peroxide containing bleaching agent. The clinical evaluation included: 1. Post-bleaching hypersensitivity. 2. Post-bleaching long-term shade stability.
| Arm | Type | Receives |
|---|---|---|
| After whitening mousse | Experimental | Other: Potassium nitrate with fluoride30 % Xylitol, 4.2 % potassium nitrate, and 1450 ppm fluoride. Topical tooth gel Gel was applied on bleached teeth for 10 minutes according to manufacturer's instructions. |
| Mi Paste Plus | Experimental | Other: Casein phosphopeptide-amorphous calcium phosphate with fluorideCasein-phosphopeptide-amorphous calcium phosphate with 0.2 % sodium fluoride (900ppm) Topical tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions |
| Hydroxyapatite and Fluoride (ReminPro) | Experimental | Other: Hydroxyapatite with fluorideHydroxyapatite (calcium and phosphate), ethanolic colophony, fluoride (1450 ppm NaF) and xylitol Topical water based tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions |
| PAMAM "poly (amido amine)" dendrimer | Experimental | Other: PAMAM-carboxylic acid dendrimerPAMAM-succinamic acid dendrimer, 1,4-diaminobutane core, generation 4 solution. 10 wt.% in water Colorless liquid The liquid was applied on bleached teeth for 30 minutes (according to previous studies) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants with their entire upper and lower teeth, from right first premolar to left first premolar, present and sound, without restorations or periodontal disease.
- The participants had low-caries index scores.
- Participants had teeth with a Vita-color shade of A2 or darker.
- Cooperative behavior patient and medically free.
- Patient ages between 18 to 40 years old
Key exclusion criteria (7 listed)
- Serious medically compromised patients.
- Smoking, alcoholism.
- Hypersensitivity to the agents used in the study.
- Lactating, pregnant patients.
- Patients with serious oral diseases, as acute necrotizing gingivitis, acute gingiva stomatitis, or those 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 |
|---|---|---|
| Potassium nitrate with fluorideBleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of the desensitizing agent recommended by the manufacturer (After Whitening Mousse), once for 10 minutes. | Other | After whitening mousse |
| Casein phosphopeptide-amorphous calcium phosphate with fluorideBleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Mi Paste Plus once for 3 minutes. | Other | Mi Paste Plus |
| Hydroxyapatite with fluorideBleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Hydroxyapatite and Fluoride (ReminPro) once for 3 minutes. | Other | Hydroxyapatite and Fluoride (ReminPro) |
| PAMAM-carboxylic acid dendrimerBleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of PAMAM once for 30 minutes. | Other | PAMAM "poly (amido amine)" dendrimer |
Primary outcome
Post-bleaching hypersensitivity
Time frame: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching
Assessment was carried out by a visual analogue scale (VAS), from 0 (no tooth sensitivity at all) to 10 (intolerable pain). The air stimulus was applied at a distance of 0.5-1 cm for 2 seconds by the maximum power of the compressed air jet from the dental unit. Then patients were asked to describe the intensity of pain by numbers from 1 to 10. Sensitivity was measured before bleaching (baseline) and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.
Shade stability
Time frame: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching
Assessment 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 in combination with constant artificial light sources; the clinic overhead lights in combination with the dental unit light directed 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 assessment was carried out before bleaching, and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.
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 El-Askary, Professor study director
Faculty of Dentistry, 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 Potassium nitrate with fluoride, Casein phosphopeptide-amorphous calcium phosphate with fluoride and Hydroxyapatite with fluoride 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 5 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 hypersensitivity (time frame: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching). 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.