Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-02 @ 4:46 PM
Study NCT ID:
NCT00662532
Status:
COMPLETED
Last Update Posted:
2011-12-12
First Post:
2008-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antibiotic Study for Dental Implants
Sponsor:
OraPharma
Organization:
Study Overview
Official Title:
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
Status:
COMPLETED
Status Verified Date:
2011-12
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:
This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.
Detailed Description:
At Visit 1, the dentist will:
* do an oral exam
* ask some questions
* decide if the person qualifies for being in the study
* make an appointment for Visit 2 if they qualify
At Visit 2 (Baseline), the dentist will:
* do a special cleaning of the implants
* examine the whole mouth
* collect some fluid
* take x-rays
* put the people into one of two groups (taking into account whether or not they smoke)
1. one group will have the study antibiotic put on all the areas in their mouth with gum problems
2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.
At Visit 4 (about 3 months later), the dentist will:
* collect fluid samples
* examine the whole mouth
* apply the antibiotic again for people in that group
At Visit 5 (about 6 months later), the dentist will:
* collect fluid samples
* examine the whole mouth
* take x-rays
* do an oral exam
* ask some questions
* decide if the person qualifies for being in the study
* make an appointment for Visit 2 if they qualify
At Visit 2 (Baseline), the dentist will:
* do a special cleaning of the implants
* examine the whole mouth
* collect some fluid
* take x-rays
* put the people into one of two groups (taking into account whether or not they smoke)
1. one group will have the study antibiotic put on all the areas in their mouth with gum problems
2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.
At Visit 4 (about 3 months later), the dentist will:
* collect fluid samples
* examine the whole mouth
* apply the antibiotic again for people in that group
At Visit 5 (about 6 months later), the dentist will:
* collect fluid samples
* examine the whole mouth
* take x-rays
Study Oversight
Has Oversight DMC:
False
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?: