Silver and Fluoride Salivary Levels After the Application of Silver Fluoride

Sponsor

Universidad Peruana Cayetano Heredia (Other)

Overall Status

Completed

CT.gov ID

NCT01860391

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

Brief 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.

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

Condition or Disease	Intervention/Treatment	Phase
Dentin Hypersensitivity	Device: Diammine Silver Fluoride	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

Salivary Levels of Fluoride and Silver 7 Days After Treatment With Diammine Silver Fluoride

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Application of Diammine 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.	Device: Diammine Silver Fluoride Diammine SIlver Fluoride will be applied to teeth. The levels of silver and fluoride in saliva will be measure up to 7 days Other Names: Silver FLuoride Saforide

Arm

Intervention/Treatment

Experimental: Application of Diammine SIlver Fluoride

Device: Diammine Silver Fluoride

Diammine SIlver Fluoride will be applied to teeth. The levels of silver and fluoride in saliva will be measure up to 7 days

Other Names:

Silver FLuoride

Saforide

Outcome Measures

Primary Outcome Measures

Silver and Fluoride levels in saliva [7 days]
The daily fluoride and silver levels in saliva will be determined after the application of silver fluoride.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with at least one canine or premolar
Patients with Dentin hypersensitivity
Patients with healthy gingiva

Exclusion Criteria:

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