Periodontitis
Conditions
Keywords
Peri-implantitis; antibiotic
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
Interventions
DRUGMinocycline HCl
1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial
Sponsors
OraPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 21 years of age and good general health * appropriately documented Informed Consent * willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol * female subjects must meet the pregnancy and contraceptive requirements * must have oral health appropriate for study inclusion
Exclusion criteria
* oral health inappropriate for study inclusion * females self-reporting pregnancy or lactation, or having a positive urine pregnancy result * reporting any of the following conditions: * allergy to a tetracycline-class drug * systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures * active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis * diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement * participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment * employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator * anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall PD Reduction | Baseline to Day 180 | Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial PD Reduction | Baseline to Day 90 | Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject |
| BOP Percent Reduction From Baseline | at Day 90 and Day 180 | Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Minocycline HCl 1 mg microspheres of minocycline hydrochloride | 22 |
| No Intervention Control group receiving no drug intervention | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Minocycline HCl | No Intervention | Total |
|---|---|---|---|
| Age Continuous | 67.59 years STANDARD_DEVIATION 12.37 | 66.05 years STANDARD_DEVIATION 10.97 | 66.82 years STANDARD_DEVIATION 11.58 |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 22 | 4 / 22 |
| serious Total, serious adverse events | 1 / 22 | 3 / 22 |
Outcome results
Primary
Overall PD Reduction
Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject
Time frame: Baseline to Day 180
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minocycline HCl | Overall PD Reduction | 1.25 mm | Standard Deviation 0.63 |
| No Intervention | Overall PD Reduction | 0.66 mm | Standard Deviation 0.63 |
Secondary
BOP Percent Reduction From Baseline
Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline
Time frame: at Day 90 and Day 180
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Minocycline HCl | BOP Percent Reduction From Baseline | Day 90 | 42.17 Percentage of Participants | Standard Deviation 38.27 |
| Minocycline HCl | BOP Percent Reduction From Baseline | Day 180 | 60.75 Percentage of Participants | Standard Deviation 32.19 |
| No Intervention | BOP Percent Reduction From Baseline | Day 90 | 22.53 Percentage of Participants | Standard Deviation 31.36 |
| No Intervention | BOP Percent Reduction From Baseline | Day 180 | 32.86 Percentage of Participants | Standard Deviation 41.35 |
Secondary
Initial PD Reduction
Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject
Time frame: Baseline to Day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minocycline HCl | Initial PD Reduction | 1.02 mm | Standard Deviation 0.63 |
| No Intervention | Initial PD Reduction | 0.49 mm | Standard Deviation 0.58 |