Teeth SensitivityNCT04112706
Efficacy of CPP-ACP on Bleaching Related Sensitivity
A study testing CPP-ACP in people with Teeth Sensitivity and Tooth Discoloration, run by University of New England at 1 site in United States.
Trial summary
Objective: The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching. Methods: 45 subjects were randomly divided into two groups, based upon which arch received MI Paste. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Teeth Sensitivity, Tooth Discoloration
- What is being tested?
- CPP-ACP
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2006to 16 Mar 2007
- 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 to 50 years
- All sexes
- Adult
Who may be able to join
- Male or female patients between the age of 18 and 50 years who were capable of providing informed consent. Subjects older than 50 were not included in the study because of more secondary dentine present less chances of developing sensitivity.
- Subject who had anterior tooth discoloration (equivalent to or darker than Vita shade A3).
- Subjects who were available for a potential recall period of one year.
- Subjects who had no severe systemic disorders. Subjects who needed antibiotics for prevention of spontaneous bacterial endocarditis (SBE) or artificial joints were included.
Who cannot join
- Subjects who had any known allergies to any materials used in this protocol.
- Patients with milk protein allergies since one of the materials used is derived from milk protein.
- Pregnant women were excluded from the study due to lack of available data for the safety of the bleaching gel for pregnant women.
- Subjects involved in other clinical trials utilizing a similar protocol.
- Subject who had used any dentist-supplied or over the counter vital tooth bleaching product in the previous six months.
- The subjects who have used any desensitizing agents including toothpaste in the past six months.
- Subjects who took COX-2 NSAIDs on daily basis or were under medical treatment at that time for major psychiatric illness that may have altered the perception of pain/discomfort and/or inhibit the subject from completing the study.
- Subjects who had any periodontal surgery or scaling performed in the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching.
Methods: 45 subjects were randomly divided into two groups, based upon which arch received MI Paste. Group 1 bleached Maxillary arch, Group 2 bleached mandibular arch. Two weeks later subjects stopped bleaching the first arch and started second arch. Sensitivity was measured by VAS daily log scale for two weeks. Shade was taken with colorimeter and Classic Vita shade guide at baseline, immediate post-bleaching, and two weeks post-bleaching. Longitudinal sensitivity over the 14 days period of bleaching was summarized. The Wilcoxon Signed Rank test was used to compare summary measures.
Read the detailed description
Study Design
This was a randomized, controlled, split-mouth cross-over design clinical trial. Subjects were randomized into two groups depending on the control and intervention arches:
- Group 1: The maxillary arch was the control arch (only bleaching) while the mandibular arch (MN) was intervention arch (bleaching and MI Paste).
- Group 2: The MN arch was the control arch (only bleaching) while the MX arch was the intervention arch (bleaching and MI Paste).
Ethical permission for the study was obtained from the University Intuitional Review Board (No. 200604706). The study was conducted in full accordance with the Helsinki Declaration and reported using CONSORT guidelines. Informed consents were obtained from the subjects prior to enrolment in the study.
Participants Forty-six participants were recruited at the Oral Health Center. Participants were included if they age between 18 and 55 years old with no prior history of bleaching, not using any desensitizing agents, and with anterior teeth of shade A2 or higher. Participants allergic to milk protein, pregnant, and/or on daily NSAIDs were excluded. They were also excluded if they have had an anterior crown or composite restoration, scaling or periodontal surgery performed in the past six months, and/or had a history of bleaching.
Intervention Both the bleaching gel (TiON whitening gel (GC America Inc) and MI paste (PROSPECTM MI paste) were delivered using custom trays with reservoir made for participants at the beginning of the study. To avoid contamination, the control arch was always bleached first. Group 1 subjects were instructed to use 15% carbamide peroxide on maxillary arch while group 2 were instructed to use it on the mandibular arch. Subjects stopped bleaching on their respective arches after 2 weeks. Subjects were then given bleach and MI paste to be used on the opposing arch (Group 1 used it on the mandibular arch and Group 2 used it on maxillary arch).
For bleaching only arch, participants were instructed to wear the trays each night for 6-8 hours for two weeks. Subjects were given a VAS daily log to document the sensitivity for two weeks. For bleach and MI Paste arch, participants were instructed to brush and floss their teeth, load the non-scalloped tray with MI Paste, wear it for 5 minutes, remove the tray, spit out the excess, and not to eat or drink for one hour. They were instructed to bleach after that for 6-8 hours for the next two weeks. Participants were instructed not to bleach the first arch anymore. Participants were given a VAS daily log to document the sensitivity score for each day for two weeks.
Measurements Measurements were made at baseline (Time 0), 2 weeks after initiation of bleaching (Time 1) and 2 weeks after the end of treatment (i.e., 4 weeks after initiation of bleaching; Time 2) for each arch. Longitudinal VAS scores were to be assessed at baseline (Day 0) and daily during the two weeks of bleaching (Days 1 through 14).
Sensitivity Sensitivity was measured using thermal sensitivity scale (VAS) of 0-10, with 0 being "no pain" and 10 being "severe pain." Subjects were asked to pick a number. Thermal sensitivity was measured by using a 1-second air blast at 70oF from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds12.
Shade Value-oriented Vita classical shade guide was used to determine the shade of the teeth under standardized conditions for color corrected light. Shade scores were ordered from 1 to 16 according to the brightness grouping recommended by the manufactures. A hand held coloriometer "Shade Vision" (X-rite, Inc) was used to measure shade digitally. Shade Vision identifies color difference using three dimensional CIE L*a*b* values system.
Participants' Survey Participants were given a survey at the end of the study examining their perception on the ease of application of MI Paste as well as the impact of MI Paste on sensitivity and gingival inflammation.
- Conditions
- Teeth Sensitivity, Tooth Discoloration
- Being tested
- CPP-ACP
- Medical subject headings
- Dentin Sensitivity, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPP-ACPDrug
CPP-ACP WAS APPLIED AFTER TOOTH BLEACHING
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sensitivity measures related to bleaching: Subjective Sensitivity
Thermal Sensitivity: Subjective Measure:
Sensitivity was measured using thermal sensitivity scale (VAS) of 0-10, with 0 being "no pain" and 10 being "severe pain". Subjects were asked to pick a number.
- Objective Measure: Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.
Measured: 28 DAYS
Change in sensitivity measures related to bleaching: Objective Sensitivity
Objective Measure:
Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.
Measured: 28 days
Secondary outcomes (1)
Shade change and interference of CPP-ACP with bleaching
Shade:
- Subjective shade measurement: Value oriented Vita classical shade guide was used to determine the shade of the teeth under standardized conditions for color corrected light. Shade scores were ordered from 1 to 16 according to the brightness grouping recommended by the manufactures.
2: Objective shade measurement: "Shade vision" (X-rite, inc) was used to take digital color images with colorimetric filtering technology.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start16 Jul 2006
- Primary completion16 Feb 2007
- Study completion16 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth 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
- Crossover
- Model description
- Randomized controlled split-mouth
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa
- Responsible party
- Principal investigator, Shaista Rashid, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112706
- Sponsor's protocol ID
- IRB 200604706
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CPP-ACP on Bleaching Related Sensitivity
- ClinicalTrials.gov ID
- NCT04112706
- Acronym / sponsor ID
- IRB 200604706
- Conditions
- Teeth Sensitivity, Tooth Discoloration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Collaborators
- University of Iowa
- Study start
- 16 Jul 2006 (actual)
- Primary completion
- 16 Feb 2007 (actual)
- Study completion
- 16 Mar 2007
- First posted
- 2 Oct 2019 (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.
Objective: The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching.
Methods: 45 subjects were randomly divided into two groups, based upon which arch received MI Paste. Group 1 bleached Maxillary arch, Group 2 bleached mandibular arch. Two weeks later subjects stopped bleaching the first arch and started second arch. Sensitivity was measured by VAS daily log scale for two weeks. Shade was taken with colorimeter and Classic Vita shade guide at baseline, immediate post-bleaching, and two weeks post-bleaching. Longitudinal sensitivity over the 14 days period of bleaching was summarized. The Wilcoxon Signed Rank test was used to compare summary measures.
Detailed description
Study Design
This was a randomized, controlled, split-mouth cross-over design clinical trial. Subjects were randomized into two groups depending on the control and intervention arches:
- Group 1: The maxillary arch was the control arch (only bleaching) while the mandibular arch (MN) was intervention arch (bleaching and MI Paste).
- Group 2: The MN arch was the control arch (only bleaching) while the MX arch was the intervention arch (bleaching and MI Paste).
Ethical permission for the study was obtained from the University Intuitional Review Board (No. 200604706). The study was conducted in full accordance with the Helsinki Declaration and reported using CONSORT guidelines. Informed consents were obtained from the subjects prior to enrolment in the study.
Participants Forty-six participants were recruited at the Oral Health Center. Participants were included if they age between 18 and 55 years old with no prior history of bleaching, not using any desensitizing agents, and with anterior teeth of shade A2 or higher. Participants allergic to milk protein, pregnant, and/or on daily NSAIDs were excluded. They were also excluded if they have had an anterior crown or composite restoration, scaling or periodontal surgery performed in the past six months, and/or had a history of bleaching.
Intervention Both the bleaching gel (TiON whitening gel (GC America Inc) and MI paste (PROSPECTM MI paste) were delivered using custom trays with reservoir made for participants at the beginning of the study. To avoid contamination, the control arch was always bleached first. Group 1 subjects were instructed to use 15% carbamide peroxide on maxillary arch while group 2 were instructed to use it on the mandibular arch. Subjects stopped bleaching on their respective arches after 2 weeks. Subjects were then given bleach and MI paste to be used on the opposing arch (Group 1 used it on the mandibular arch and Group 2 used it on maxillary arch).
For bleaching only arch, participants were instructed to wear the trays each night for 6-8 hours for two weeks. Subjects were given a VAS daily log to document the sensitivity for two weeks. For bleach and MI Paste arch, participants were instructed to brush and floss their teeth, load the non-scalloped tray with MI Paste, wear it for 5 minutes, remove the tray, spit out the excess, and not to eat or drink for one hour. They were instructed to bleach after that for 6-8 hours for the next two weeks. Participants were instructed not to bleach the first arch anymore. Participants were given a VAS daily log to document the sensitivity score for each day for two weeks.
Measurements Measurements were made at baseline (Time 0), 2 weeks after initiation of bleaching (Time 1) and 2 weeks after the end of treatment (i.e., 4 weeks after initiation of bleaching; Time 2) for each arch. Longitudinal VAS scores were to be assessed at baseline (Day 0) and daily during the two weeks of bleaching (Days 1 through 14).
Sensitivity Sensitivity was measured using thermal sensitivity scale (VAS) of 0-10, with 0 being "no pain" and 10 being "severe pain." Subjects were asked to pick a number. Thermal sensitivity was measured by using a 1-second air blast at 70oF from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds12.
Shade Value-oriented Vita classical shade guide was used to determine the shade of the teeth under standardized conditions for color corrected light. Shade scores were ordered from 1 to 16 according to the brightness grouping recommended by the manufactures. A hand held coloriometer "Shade Vision" (X-rite, Inc) was used to measure shade digitally. Shade Vision identifies color difference using three dimensional CIE L*a*b* values system.
Participants' Survey Participants were given a survey at the end of the study examining their perception on the ease of application of MI Paste as well as the impact of MI Paste on sensitivity and gingival inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Model description
- Randomized controlled split-mouth
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female patients between the age of 18 and 50 years who were capable of providing informed consent. Subjects older than 50 were not included in the study because of more secondary dentine present less chances of developing sensitivity.
- Subject who had anterior tooth discoloration (equivalent to or darker than Vita shade A3).
- Subjects who were available for a potential recall period of one year.
- Subjects who had no severe systemic disorders. Subjects who needed antibiotics for prevention of spontaneous bacterial endocarditis (SBE) or artificial joints were included.
Key exclusion criteria (8 listed)
- Subjects who had any known allergies to any materials used in this protocol.
- Patients with milk protein allergies since one of the materials used is derived from milk protein.
- Pregnant women were excluded from the study due to lack of available data for the safety of the bleaching gel for pregnant women.
- Subjects involved in other clinical trials utilizing a similar protocol.
- Subject who had used any dentist-supplied or over the counter vital tooth bleaching product in the previous six months.
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 |
|---|---|---|
| CPP-ACPCPP-ACP WAS APPLIED AFTER TOOTH BLEACHING | Drug | – |
Primary outcome
Change in sensitivity measures related to bleaching: Subjective Sensitivity
Time frame: 28 DAYS
Thermal Sensitivity: Subjective Measure: Sensitivity was measured using thermal sensitivity scale (VAS) of 0-10, with 0 being "no pain" and 10 being "severe pain". Subjects were asked to pick a number. 2. Objective Measure: Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.
Change in sensitivity measures related to bleaching: Objective Sensitivity
Time frame: 28 days
Objective Measure: Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.
1 secondary outcome
Shade change and interference of CPP-ACP with bleaching
Time frame: 14 days
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 2 Oct 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPP-ACP in people with Teeth Sensitivity and Tooth Discoloration, run by University of New England at 1 site in United States.
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 4 inclusion and 8 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 2 Oct 2019. 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 United States. 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.
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 measures related to bleaching: Subjective Sensitivity (time frame: 28 DAYS). 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 2 Oct 2019.