Dentin HypersensitivityNCT01860391
Silver and Fluoride Salivary Levels After the Application of Silver Fluoride
A study testing Diammine Silver Fluoride in people with Dentin Hypersensitivity, run by Universidad Peruana Cayetano Heredia.
Trial summary
The aim of the study is to measure salivary fluoride and silver levels up to 7 days post-treatment. The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to use the day before the study and all during the study. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Diammine Silver Fluoride
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2012
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with at least one canine or premolar
- Patients with Dentin hypersensitivity
- Patients with healthy gingiva
Who cannot join
- Patients taking any of these medication: antidepressivem anticonvulsive, antihistaminic, antihypertension, antihemetic, antiespasmodic.
- Pregnancy
- Patients under radiation therapy
- Patients under chemotherapy
- Patients with alterations of salivary glands like Sjogren syndrome or Diabetes Mellitus with Xerostomia
- Patients with sensitivity to silver or other ions of heavy metals
About this study
Official title: Salivary Levels of Fluoride and Silver 7 Days After Treatment With Diammine Silver Fluoride
The aim of the study is to measure salivary fluoride and silver levels up to 7 days post-treatment.
The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to use the day before the study and all during the study.
Read more
3 participants will have 6 teeth treated (Group A).3 participants will have 28 teeth treated each on the facial aspect (Group B).
On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3 times.
On day 0, 10 minutes after the rinsing and spitting, the participant will provide a unstimulated salivary sample into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.
On Day 0, Isolation and application of silver fluoride.
The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with petroleum jelly to provide additional protection.
After application, participant will be given 25 ml of fluoride free water to rinse as in 1 above and water collected. This will be done 10 times.
DAY 1-6 Salivary Collection
Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry (EPA 6020a Rev.1 2007) at the University of Washington
Read the detailed description
Aim: to measure salivary fluoride and silver levels up to 7 days post-treatment. Based on extrapolation of the study by Vasquez and colleagues (2012), it is hypothesized that 7-day levels in the clinical study will not exceed baseline values.
Participants: 6 healthy adults of either sex, 21+ years old, who do not have gingivitis but who have generalized gingival recession >1mm, 3 subjects must have at least 28 teeth.
Participants will be given a fluoride free toothpaste to use the day before the study and all during the study. Participants will be reminded not to use fluoride toothpaste or other fluoride products and to avoid fish and tea.
No toothbrushing or eating at all within an hour of any visit
Design: Observational study with each participant as his/her own control.
3 participants will 6 treated (Group A).3 participants will have 28 teeth treated each on the facial aspect (Group B). Teeth with anterior fillings or decay at the gingival where staining would show will not be treated.
Day 0 Procedures:
- On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3 times.
- On day 0, 10 minutes after the rinsing and spitting, the participant will provide a unstimulated salivary sample. The individual will be instructed to swallow once, and allow saliva to pool in the mouth without swallowing, and then periodically spit the saliva into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.
- Day 0, Isolation and application of silver fluoride. GROUP A (6 TEETH): 18 mcL will be expressed from a Hamilton syringe into a dappen dish, and then a single preweighed microbrush will be used to apply the material to the tooth surface after drying with cotton gauze. The 6 teeth will be treated consecutively until all the material in the dappen dish will be used. Then the brush will be reweighed to establish the non-applied amount. GROUP B (28 TEETH) Measure out 3 mcL X number of teeth present into dappen dish. Procedure is the same. Application of silver fluoride. The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with petroleum jelly to provide additional protection.
- Day 0, after application, participant will be given 25 ml of fluoride free water to rinse as in 1 above and water collected. This will be done 10 times. DAY 1-6 Salivary Collection
- Days 1-6, collection a single salivary sample at same time each day.
Procedure: Ten minutes before collection (on days 1-6), each individual will be given 100 ml of de-ionized fluoride free water to rinse the mouth and swallow to increase hydration. The individual will be instructed to swallow once, and allow saliva to pool in the mouth without swallowing, and then periodically spit the saliva into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.
Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry (EPA 6020a Rev.1 2007).
- Conditions
- Dentin Hypersensitivity
- Being tested
- Diammine Silver Fluoride
- Keywords
- Silver, Fluoride, Diammine Silver Fluoride, Saliva
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diammine Silver FluorideDevice
Also called Silver FLuoride, Saforide
Diammine SIlver Fluoride will be applied to teeth. The levels of silver and fluoride in saliva will be measure up to 7 days
| Study group | Role | What they receive |
|---|---|---|
| Application of Diammine SIlver Fluoride | Experimental | GROUP A (6 TEETH): 18 mcL will be expressed from a Hamilton syringe into a dappen dish, and then a single preweighed microbrush will be used to apply the material to the tooth surface after drying with cotton gauze. The 6 teeth will be treated consecutively until all the material in the dappen dish will be used. Then the brush will be reweighed to establish the non-applied amount.
GROUP B (28 TEETH) Measure out 3 mcL X number of teeth present into dappen dish. Procedure is the same. Receives: Device: Diammine Silver Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silver and Fluoride levels in saliva
The daily fluoride and silver levels in saliva will be determined after the application of silver fluoride.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Romo, DDS, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860391
- Sponsor's protocol ID
- 0000060585
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Levels of Fluoride and Silver 7 Days After Treatment With Diammine Silver Fluoride
- ClinicalTrials.gov ID
- NCT01860391
- Acronym / sponsor ID
- 0000060585
- Conditions
- Dentin Hypersensitivity
- Keywords
- Silver, Fluoride, Diammine Silver Fluoride, Saliva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 May 2013 (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.
The aim of the study is to measure salivary fluoride and silver levels up to 7 days post-treatment.
The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to use the day before the study and all during the study.
3 participants will have 6 teeth treated (Group A).3 participants will have 28 teeth treated each on the facial aspect (Group B).
On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3 times.
On day 0, 10 minutes after the rinsing and spitting, the participant will provide a unstimulated salivary sample into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.
On Day 0, Isolation and application of silver fluoride.
The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with petroleum jelly to provide additional protection.
After application, participant will be given 25 ml of fluoride free water to rinse as in 1 above and water collected. This will be done 10 times.
DAY 1-6 Salivary Collection
Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry (EPA 6020a Rev.1 2007) at the University of Washington
Detailed description
Aim: to measure salivary fluoride and silver levels up to 7 days post-treatment. Based on extrapolation of the study by Vasquez and colleagues (2012), it is hypothesized that 7-day levels in the clinical study will not exceed baseline values.
Participants: 6 healthy adults of either sex, 21+ years old, who do not have gingivitis but who have generalized gingival recession >1mm, 3 subjects must have at least 28 teeth.
Participants will be given a fluoride free toothpaste to use the day before the study and all during the study. Participants will be reminded not to use fluoride toothpaste or other fluoride products and to avoid fish and tea.
No toothbrushing or eating at all within an hour of any visit
Design: Observational study with each participant as his/her own control.
3 participants will 6 treated (Group A).3 participants will have 28 teeth treated each on the facial aspect (Group B). Teeth with anterior fillings or decay at the gingival where staining would show will not be treated.
Day 0 Procedures:
- On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3 times.
- On day 0, 10 minutes after the rinsing and spitting, the participant will provide a unstimulated salivary sample. The individual will be instructed to swallow once, and allow saliva to pool in the mouth without swallowing, and then periodically spit the saliva into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.
- Day 0, Isolation and application of silver fluoride. GROUP A (6 TEETH): 18 mcL will be expressed from a Hamilton syringe into a dappen dish, and then a single preweighed microbrush will be used to apply the material to the tooth surface after drying with cotton gauze. The 6 teeth will be treated consecutively until all the material in the dappen dish will be used. Then the brush will be reweighed to establish the non-applied amount. GROUP B (28 TEETH) Measure out 3 mcL X number of teeth present into dappen dish. Procedure is the same. Application of silver fluoride. The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with petroleum jelly to provide additional protection.
- Day 0, after application, participant will be given 25 ml of fluoride free water to rinse as in 1 above and water collected. This will be done 10 times. DAY 1-6 Salivary Collection
- Days 1-6, collection a single salivary sample at same time each day.
Procedure: Ten minutes before collection (on days 1-6), each individual will be given 100 ml of de-ionized fluoride free water to rinse the mouth and swallow to increase hydration. The individual will be instructed to swallow once, and allow saliva to pool in the mouth without swallowing, and then periodically spit the saliva into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.
Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry (EPA 6020a Rev.1 2007).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application of Diammine SIlver Fluoride | Experimental | Device: Diammine Silver FluorideGROUP A (6 TEETH): 18 mcL will be expressed from a Hamilton syringe into a dappen dish, and then a single preweighed microbrush will be used to apply the material to the tooth surface after drying with cotton gauze. The 6 teeth will be treated consecutively until all the material in the dappen dish will be used. Then the brush will be reweighed to establish the non-applied amount. GROUP B (28 TEETH) Measure out 3 mcL X number of teeth present into dappen dish. Procedure is the same. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with at least one canine or premolar
- Patients with Dentin hypersensitivity
- Patients with healthy gingiva
Key exclusion criteria (6 listed)
- Patients taking any of these medication: antidepressivem anticonvulsive, antihistaminic, antihypertension, antihemetic, antiespasmodic.
- Pregnancy
- Patients under radiation therapy
- Patients under chemotherapy
- Patients with alterations of salivary glands like Sjogren syndrome or Diabetes Mellitus with Xerostomia
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 |
|---|---|---|
| Diammine Silver FluorideAlso: Silver FLuoride, SaforideDiammine SIlver Fluoride will be applied to teeth. The levels of silver and fluoride in saliva will be measure up to 7 days | Device | Application of Diammine SIlver Fluoride |
Primary outcome
Silver and Fluoride levels in saliva
Time frame: 7 days
The daily fluoride and silver levels in saliva will be determined after the application of silver fluoride.
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 22 May 2013.
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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.
Adriana Romo, DDS principal investigator
Universidad Peruana Cayetano Heredia
Questions about this trial
What is this clinical trial studying?
A study testing Diammine Silver Fluoride in people with Dentin Hypersensitivity, run by Universidad Peruana Cayetano Heredia.
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 3 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 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Silver and Fluoride levels in saliva (time frame: 7 days). 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 22 May 2013.