Dentin HypersensitivityNCT03068533
8% L-Arginine/Calcium Carbonate Toothpaste in Comparison to Strontium Acetate Toothpaste for Hypersensitive Dentin
A study testing 8% L-Arginine/calcium carbonate containing toothpaste and use of strontium acetate toothpaste in people with Dentin Hypersensitivity, run by Cairo University at 1 site in Egypt.
Trial summary
Dentinal hypersensitivity [DH] is a common condition in daily practice, especially in patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect individuals in the age range of 20-50 years.In a recent systematic review, it was reported that no gold standard treatment modality for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- 8% L-Arginine/calcium carbonate containing toothpaste and use of strontium acetate toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Apr 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Slight to moderate chronic periodontitis patients diagnosed according to criteria of (Parameter on chronic periodontitis with slight to moderate loss of periodontal support.
- American Academy of Periodontology., 2000) as follows : Probing pocket depths up to 6mm Clinical attachment loss (CAL) up to 4mm Class I (incipient) furcation involvement Radiographic evidence of bone loss.
- At least 2 teeth presenting hypersensitive areas on facial surfaces of teeth with score 2 or 3 on the air sensitivity scale (Pepelassi et al., 2015)
- Provision of written informed consent
Who cannot join
- Chipped teeth.
- Defective restorations.
- Deep dental caries or large restorations showing pulpal response.
- Ongoing treatment with anti-inflammatory drugs.
- Ongoing treatment for tooth hypersensitivity.
- Pregnancy.
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- Uncontrolled metabolic diseases.
- Psychiatric disorder.
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of 8% L-Arginine/Calcium Carbonate Containing Toothpaste in Comparison to Strontium Acetate Containing Toothpaste in Management of Hypersensitive Dentine in Chronic Periodontitis Patients : A Randomized-controlled Clinical Trial
Dentinal hypersensitivity [DH] is a common condition in daily practice, especially in patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect individuals in the age range of 20-50 years.In a recent systematic review, it was reported that no gold standard treatment modality for dentin hypersensitivity has been established Thus there is a need to evaluate new formulations in different settings and in different populations and to compare those to commonly used agents seeking better results in pain relief for our patients. Studies showed that dentifrice formulations containing 8% arginine in combination with calcium carbonate and fluoride have the ability to plug dentinal tubules, by clumping of both arginine and calcium carbonate that bind with the negatively charged dentin . Aim of the study is to clinically evaluate toothpaste containing 8% arginine, calcium carbonate, and sodium mono-fluorophosphate, in comparison to toothpaste, containing 8% strontium acetate and NaF on the relief of DH in chronic periodontitis patients.
Read the detailed description
- Each eligible patient will be given a number.
- All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
- The hypersensitive teeth will be isolated with cotton rolls, and stimuli will be applied to each tooth for final evaluation after scaling and debridement.
- Air Sensitivity scale is used to assess sensitivity to air blast, while cold water test and tactile test will be held and assessed by Visual Analog Scale (VAS) , which score from 0 (no pain) to 10 (intense pain).
- Patients will be handed a 30ml. white package written on it the previously assigned number to them and instructed to brush twice daily with the assigned toothpaste by a soft-bristled toothbrush for 8 weeks, with several returns to the clinic for re-evaluation and to take the refill of the assigned number of toothpaste.
- Air blast sensitivity score and VAS will be evaluated again weekly and till the end of the evaluation period.
- Conditions
- Dentin Hypersensitivity
- Being tested
- 8% L-Arginine/calcium carbonate containing toothpaste, use of strontium acetate toothpaste
- Keywords
- DH, dentin hypersensitivity, chronic periodontitis
- Medical subject headings
- Dentin Sensitivity, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8% L-Arginine/calcium carbonate containing toothpasteOther
use of 8% L-Arginine/calcium carbonate containing toothpaste to relieve hypersensitivity
use of strontium acetate toothpasteOther
use of strontium acetate toothpaste to relieve hypersensitivity
| Study group | Role | What they receive |
|---|---|---|
| Strontium acetate toothpaste | Active comparator | All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation. Receives: Other: use of strontium acetate toothpaste |
| Arginine/calcium carbonate toothpaste | Experimental | All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation. Receives: Other: 8% L-Arginine/calcium carbonate containing toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline Pain (sensetivity) at 8 weeks
This will be assessed using VAS that will be determined immediately before product use and then after 8 weeks of daily brushing with the test and control toothpastes following stimulus application using Visual Analog Scale (VAS)
Measured: baseline and after 8 weeks
Secondary outcomes (2)
Probing pocket depth
probing depth from gingival margin and till base of the pocket or sulcus in mm.
Measured: baseline and after 8 weeks
Gingival recession (GR)
if present, distance between gingival margin to cemento-enamel junction in mm.
Measured: baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Jan 2018
- Primary completion3 Mar 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Hassan Mostafa, Cairo University
- Investigators
- Prof.Dr. Manal Hosni, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068533
- Sponsor's protocol ID
- Abdallah Hassan
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2017
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 8% L-Arginine/Calcium Carbonate Containing Toothpaste in Comparison to Strontium Acetate Containing Toothpaste in Management of Hypersensitive Dentine in Chronic Periodontitis Patients : A Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03068533
- Acronym / sponsor ID
- Abdallah Hassan
- Conditions
- Dentin Hypersensitivity
- Keywords
- DH, dentin hypersensitivity, chronic periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 3 Mar 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 3 Mar 2017 (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.
Dentinal hypersensitivity [DH] is a common condition in daily practice, especially in patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect individuals in the age range of 20-50 years.In a recent systematic review, it was reported that no gold standard treatment modality for dentin hypersensitivity has been established Thus there is a need to evaluate new formulations in different settings and in different populations and to compare those to commonly used agents seeking better results in pain relief for our patients. Studies showed that dentifrice formulations containing 8% arginine in combination with calcium carbonate and fluoride have the ability to plug dentinal tubules, by clumping of both arginine and calcium carbonate that bind with the negatively charged dentin . Aim of the study is to clinically evaluate toothpaste containing 8% arginine, calcium carbonate, and sodium mono-fluorophosphate, in comparison to toothpaste, containing 8% strontium acetate and NaF on the relief of DH in chronic periodontitis patients.
Detailed description
- Each eligible patient will be given a number.
- All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
- The hypersensitive teeth will be isolated with cotton rolls, and stimuli will be applied to each tooth for final evaluation after scaling and debridement.
- Air Sensitivity scale is used to assess sensitivity to air blast, while cold water test and tactile test will be held and assessed by Visual Analog Scale (VAS) , which score from 0 (no pain) to 10 (intense pain).
- Patients will be handed a 30ml. white package written on it the previously assigned number to them and instructed to brush twice daily with the assigned toothpaste by a soft-bristled toothbrush for 8 weeks, with several returns to the clinic for re-evaluation and to take the refill of the assigned number of toothpaste.
- Air blast sensitivity score and VAS will be evaluated again weekly and till the end of the evaluation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strontium acetate toothpaste | Active comparator | Other: use of strontium acetate toothpasteAll eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation. |
| Arginine/calcium carbonate toothpaste | Experimental | Other: 8% L-Arginine/calcium carbonate containing toothpasteAll eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Slight to moderate chronic periodontitis patients diagnosed according to criteria of (Parameter on chronic periodontitis with slight to moderate loss of periodontal support.
- American Academy of Periodontology., 2000) as follows : Probing pocket depths up to 6mm Clinical attachment loss (CAL) up to 4mm Class I (incipient) furcation involvement Radiographic evidence of bone loss.
- At least 2 teeth presenting hypersensitive areas on facial surfaces of teeth with score 2 or 3 on the air sensitivity scale (Pepelassi et al., 2015)
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Chipped teeth.
- Defective restorations.
- Deep dental caries or large restorations showing pulpal response.
- Ongoing treatment with anti-inflammatory drugs.
- Ongoing treatment for tooth hypersensitivity.
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 |
|---|---|---|
| 8% L-Arginine/calcium carbonate containing toothpasteuse of 8% L-Arginine/calcium carbonate containing toothpaste to relieve hypersensitivity | Other | Arginine/calcium carbonate toothpaste |
| use of strontium acetate toothpasteuse of strontium acetate toothpaste to relieve hypersensitivity | Other | Strontium acetate toothpaste |
Primary outcome
change from baseline Pain (sensetivity) at 8 weeks
Time frame: baseline and after 8 weeks
This will be assessed using VAS that will be determined immediately before product use and then after 8 weeks of daily brushing with the test and control toothpastes following stimulus application using Visual Analog Scale (VAS)
2 secondary outcomes
Probing pocket depth
Time frame: baseline and after 8 weeks
Gingival recession (GR)
Time frame: baseline and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Prof.Dr. Manal Hosni study director
Cairo 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 8% L-Arginine/calcium carbonate containing toothpaste and use of strontium acetate toothpaste in people with Dentin Hypersensitivity, run by Cairo 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Feb 2018. 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.
Are results available for this study?
Results are not available in the source record.
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 from baseline Pain (sensetivity) at 8 weeks (time frame: baseline and after 8 weeks). 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 14 Feb 2018.