Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127244
Status:
COMPLETED
Last Update Posted:
2010-12-02
First Post:
2005-08-04
Brief Title:
Study Comparing Two Different Methods of Treating Periodontal Disease
Sponsor:
The Forsyth Institute
Organization:
The Forsyth Institute
Study Overview
Official Title:
Outcomes of Traditional and Medical Models of Periodontal Therapy
Status:
COMPLETED
Status Verified Date:
2010-11
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:
The purposes of this study are to
1 compare the clinical effectiveness of a traditional and a medical model of periodontal therapy and
2 determine the value of the two approaches to periodontal therapy
1 compare the clinical effectiveness of a traditional and a medical model of periodontal therapy and
2 determine the value of the two approaches to periodontal therapy
Detailed Description:
This application was developed to test the following hypothesis A medical model of periodontal therapy when compared to a traditional model is as clinically effective is more valuable and can be realistically implemented in clinical practice To accomplish this task a prospective blinded community based cohort trial will be carried out Two analytical techniques will be employed to compare the outcomes of periodontal therapy clinical effectiveness and value The two primary outcome variables for assessing clinical effectiveness will be clinician centered attachment level and patient centered quality of life The key outcome variable for value determination is cost of care Value is then determined by dividing the outcome by the cost of care Thus a similar outcome at reduced cost increases value This facilitates calculating cost-effectiveness and cost-utility of care preparing decision analysis trees and carrying out sensitivity analysis
There are two significant reasons for testing a medical model of care If the hypothesis is correct
1 this would increase access to periodontal care and
2 it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems
These points argue for a direct comparison of the medical and traditional models of care
There are two significant reasons for testing a medical model of care If the hypothesis is correct
1 this would increase access to periodontal care and
2 it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems
These points argue for a direct comparison of the medical and traditional models of care
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE013850 | NIH | None | None |
| DE-013850 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DE013850 |