Optimised Fluoride Prevention by Double Rinse With Fluori... | NCT01473537

Studies
Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

NCT01473537

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Sep 25, 2012Estimated

Enrollment

9Actual

Phase

Phase 1

Conditions

Dental Caries

Interventions

calcium lactate solution

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-001885-16	EudraCT Number

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 14, 2011

First Submission Date that Met QC Criteria

Nov 14, 2011

First Posted Date

Nov 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2012

Last Update Posted Date

Sep 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.

Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution.

Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration.

Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
calcium lactate solution 75 mM	Active Comparator	Drug: calcium lactate solution
calcium lactate solution 150 mM	Active Comparator	Drug: calcium lactate solution
placebo	Placebo Comparator	Drug: calcium lactate solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
calcium lactate solution	Drug	Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo	calcium lactate solution 150 mM calcium lactate solution 75 mM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fluoride concentration in resting saliva		12 hours after rinse

Secondary Outcomes

Measure	Description	Time Frame
Discomfort by calcium lactate rinse		12 hours after rinse

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
10 natural teeth or more
willing to refrain from use of fluoride containing products
signed informed consent

Exclusion Criteria:

less than 10 natural teeth
reduced cognitive skills
does not speak and/or understand Swedish
ongoing oral or systemic infections
pregnancy
breast feeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunilla Sandborgh-Englund, Prof, DDS	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institutet, Dept Dental Medicine		Huddinge		SE14104	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided