Tooth SensitivityNCT03026725
Effect of Tri Calcium Phosphate on Efficacy and Sensitivity With Vital Tooth Whitening Using 20% Carbamide Peroxide
A study testing Tri-calcium Phosphate in people with Tooth Sensitivity, run by Damascus University at 1 site in Syria.
Trial summary
Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity associated with At-Home vital tooth whitening using 20% carbamide peroxide Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Sensitivity
- What is being tested?
- Tri-calcium Phosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSyria
- Study dates
- Nov 2016to Feb 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good dental health
- Six maxillary anterior teeth present and healthy with no restorations or carious lesions
- Teeth darker than Vita A2 shade
- No history of teeth sensitivity
- No use of a desensitizing agent or desensitizing toothpaste in the past three months
Who cannot join
- Active caries or periodontal disease
- Allergies to bleaching agent or tray material
- pregnancy and breastfeeding during the trial
- tetracycline-stained teeth or fluoride or non-vital teeth
- Smoker
- Using tooth bleaching products during the last 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tri Calcium Phosphate Paste on Efficacy and Postoperative Sensitivity Associated With At-Home Vital Tooth Whitening Using 20% Carbamide Peroxide 'A Randomized Controlled Study'
Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity associated with At-Home vital tooth whitening using 20% carbamide peroxide
Read the detailed description
Subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide 4h/day for a week, the sample will be divided into two groups : the experimental group will apply tri calcium phosphate containing paste(Clinpro) 30 min/day after bleaching treatment, the control group will apply placebo paste 30 min/day after bleaching treatment,
- Conditions
- Tooth Sensitivity
- Being tested
- Tri-calcium Phosphate, Placebo
- Keywords
- tooth sensitivity, tri calcium phosphate, at-home whitening
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-calcium PhosphateOther
Also called ( Clinpro™ Tooth Crème, 3M ESPE, USA
A paste contains Tri Calcium Phosphate \& Fluoride
PlaceboOther
paste manufactured to mimic Clinpro, without Tri Calcium Phosphate
| Study group | Role | What they receive |
|---|---|---|
| Tri-calcium Phosphate | Experimental | clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20% Receives: Other: Tri-calcium Phosphate |
| Placebo | Placebo comparator | a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20% Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sensitivity Status
using a visual analog scale (VAS)
Measured: at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application
Secondary outcomes (1)
Change in Color Shade
color shade change will be detected; using Vita Easy Shadeِ Advance 4.0.
Measured: at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth SensitivityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oula Yassin, DDS, MSc,Phd, Principal investigator, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026725
- Sponsor's protocol ID
- UDDS-OperDent-03-2016
- Status last verified
- Apr 2017
- First submitted
- 18 Jan 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Maghaireh GA, Alzraikat H, Guidoum A. Assessment of the effect of casein phosphopeptide-amorphous calcium phosphate on postoperative sensitivity associated with in-office vital tooth whitening. Oper Dent. 2014 May-Jun;39(3):239-47. doi: 10.2341/12-527-C. Epub 2013 Oct 22.
PubMed 24147745Loguercio AD, Tay LY, Herrera DR, Bauer J, Reis A. Effectiveness of nano-calcium phosphate paste on sensitivity during and after bleaching: a randomized clinical trial. Braz Oral Res. 2015;29:1-7. doi: 10.1590/1807-3107BOR-2015.vol29.0099. Epub 2015 Aug 21.
PubMed 26313348Pintado-Palomino K, Peitl Filho O, Zanotto ED, Tirapelli C. A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching. J Dent. 2015 Sep;43(9):1099-1105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6.
PubMed 26159384Dawson PF, Sharif MO, Smith AB, Brunton PA. A clinical study comparing the efficacy and sensitivity of home vs combined whitening. Oper Dent. 2011 Sep-Oct;36(5):460-6. doi: 10.2341/10-159-C. Epub 2011 Aug 22.
PubMed 21859318Basting RT, Amaral FL, Franca FM, Florio FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent. 2012 Sep-Oct;37(5):464-73. doi: 10.2341/11-337-C. Epub 2012 May 18.
PubMed 22616927
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tri Calcium Phosphate Paste on Efficacy and Postoperative Sensitivity Associated With At-Home Vital Tooth Whitening Using 20% Carbamide Peroxide 'A Randomized Controlled Study'
- ClinicalTrials.gov ID
- NCT03026725
- Acronym / sponsor ID
- UDDS-OperDent-03-2016
- Conditions
- Tooth Sensitivity
- Keywords
- tooth sensitivity, tri calcium phosphate, at-home whitening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- 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.
Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity associated with At-Home vital tooth whitening using 20% carbamide peroxide
Detailed description
Subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide 4h/day for a week, the sample will be divided into two groups : the experimental group will apply tri calcium phosphate containing paste(Clinpro) 30 min/day after bleaching treatment, the control group will apply placebo paste 30 min/day after bleaching treatment,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tri-calcium Phosphate | Experimental | Other: Tri-calcium Phosphateclinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20% |
| Placebo | Placebo comparator | Other: Placeboa placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good dental health
- Six maxillary anterior teeth present and healthy with no restorations or carious lesions
- Teeth darker than Vita A2 shade
- No history of teeth sensitivity
- No use of a desensitizing agent or desensitizing toothpaste in the past three months
Key exclusion criteria (6 listed)
- Active caries or periodontal disease
- Allergies to bleaching agent or tray material
- pregnancy and breastfeeding during the trial
- tetracycline-stained teeth or fluoride or non-vital teeth
- Smoker
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 |
|---|---|---|
| Tri-calcium PhosphateAlso: ( Clinpro™ Tooth Crème, 3M ESPE, USAA paste contains Tri Calcium Phosphate \& Fluoride | Other | Tri-calcium Phosphate |
| Placebopaste manufactured to mimic Clinpro, without Tri Calcium Phosphate | Other | Placebo |
Primary outcome
Change in Sensitivity Status
Time frame: at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application
using a visual analog scale (VAS)
1 secondary outcome
Change in Color Shade
Time frame: at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application
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 13 Apr 2017.
- Background: PubMed 24147745Maghaireh GA, Alzraikat H, Guidoum A. Assessment of the effect of casein phosphopeptide-amorphous calcium phosphate on postoperative sensitivity associated with in-office vital tooth whitening. Oper Dent. 2014 May-Jun;39(3):239-47. doi: 10.2341/12-527-C. Epub 2013 Oct 22.
- Background: PubMed 26313348Loguercio AD, Tay LY, Herrera DR, Bauer J, Reis A. Effectiveness of nano-calcium phosphate paste on sensitivity during and after bleaching: a randomized clinical trial. Braz Oral Res. 2015;29:1-7. doi: 10.1590/1807-3107BOR-2015.vol29.0099. Epub 2015 Aug 21.
- Background: PubMed 26159384Pintado-Palomino K, Peitl Filho O, Zanotto ED, Tirapelli C. A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching. J Dent. 2015 Sep;43(9):1099-1105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6.
- Background: PubMed 21859318Dawson PF, Sharif MO, Smith AB, Brunton PA. A clinical study comparing the efficacy and sensitivity of home vs combined whitening. Oper Dent. 2011 Sep-Oct;36(5):460-6. doi: 10.2341/10-159-C. Epub 2011 Aug 22.
- Background: PubMed 22616927Basting RT, Amaral FL, Franca FM, Florio FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent. 2012 Sep-Oct;37(5):464-73. doi: 10.2341/11-337-C. Epub 2012 May 18.
- 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.
Oula Yassin, DDS, MSc,Phd principal investigator
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-calcium Phosphate in people with Tooth Sensitivity, run by Damascus University at 1 site in Syria.
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 6 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 13 Apr 2017. 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 Syria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Sensitivity Status (time frame: at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026725, which also lists 5 linked publications.
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 13 Apr 2017.