Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471783
Status:
COMPLETED
Last Update Posted:
2008-08-15
First Post:
2007-05-08
Brief Title:
Flossing With Chlorhexidine
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if flossing with a dental floss presoaked in chlorhexidine an anti-microbial mouth wash would improve the clinical signs of gingivitis an inflammation of the gums characterized by red swollen bleeding gums And to determine if applying chlorhexidine via dental floss would result in tooth staining which is common with chlorhexidine mouthwashes
Detailed Description:
Purpose of study To determine if dental floss presoaked in 012 chlorhexidine is more effective at reducing the signs of gingivitis such as bleeding than a dental floss in placebo solution of 01 quinine sulphate
Trial design The study will consist of a double-blinded placebo-controlled parallel three-month clinical trial
Randomization of subjects into study groups Subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects
Trial schedule
1 Screening for potential subjects consent obtained Calibration of examiner
2 Week -1 Professional prophylaxis consisting of scaling and polishing
3 Week 0 Baseline data GI SI PI BOP PD collected on subjects enrolled into the study OHI - flossing Subject randomized into a study group
4 Week 6 Subjects reassessed for GI SI PI BOP PD Compliance check Replenish floss supply Subject concerns or questions addressed
5 Week 12 Subjects reassessed for GI SI PI BOP PD All floss boxes and logbook returned Subject concerns or questions addressed Subject exited from study and returned to the care of his or her regular dental professional
Measurements for data collection done in this order
1 Gingival index GI modification of Löe Silness 1963
2 Stain Index SI
3 Plaque index PI modification of Silness and Löe 1964
4 Bleeding on Probing BOP
5 Probing Depth PD
Trial design The study will consist of a double-blinded placebo-controlled parallel three-month clinical trial
Randomization of subjects into study groups Subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects
Trial schedule
1 Screening for potential subjects consent obtained Calibration of examiner
2 Week -1 Professional prophylaxis consisting of scaling and polishing
3 Week 0 Baseline data GI SI PI BOP PD collected on subjects enrolled into the study OHI - flossing Subject randomized into a study group
4 Week 6 Subjects reassessed for GI SI PI BOP PD Compliance check Replenish floss supply Subject concerns or questions addressed
5 Week 12 Subjects reassessed for GI SI PI BOP PD All floss boxes and logbook returned Subject concerns or questions addressed Subject exited from study and returned to the care of his or her regular dental professional
Measurements for data collection done in this order
1 Gingival index GI modification of Löe Silness 1963
2 Stain Index SI
3 Plaque index PI modification of Silness and Löe 1964
4 Bleeding on Probing BOP
5 Probing Depth PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None