Adult Periodontitis
Conditions
Brief summary
Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.
Interventions
DRUGminocycline HCl 2.1%
Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.
PROCEDUREScaling and root planing
scaling and root planing
Sponsors
Sunstar Americas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* moderate to severe periodontitis
Exclusion criteria
* recent periodontal therapy * certain medical or dental conditions * pregnancy * allergy to active drug or related drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pocket Depth. | baseline & 9 months | Average change of Pocket Depth at 9 months from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Scaling and Root Planing + SHAM TX sham treatment
Scaling and root planing : scaling and root planing | 200 |
| Scaling & Root Planing + Periocline Gel Minocycline HCL 2.1%
minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months. | 202 |
| Scaling and Root Planing + Vehicle Placebo
Scaling and root planing : scaling and root planing | 200 |
| Total | 602 |
Baseline characteristics
| Characteristic | Scaling & Root Planing + Periocline Gel | Scaling and Root Planing + Vehicle | Scaling and Root Planing + SHAM TX | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 2 Participants | 7 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 196 Participants | 198 Participants | 193 Participants | 587 Participants |
| Age, Continuous | 49.2 years STANDARD_DEVIATION 11.8 | 50.2 years STANDARD_DEVIATION 12 | 49.8 years STANDARD_DEVIATION 11.5 | 49.7 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 202 participants | 200 participants | 200 participants | 602 participants |
| Sex: Female, Male Female | 108 Participants | 93 Participants | 99 Participants | 300 Participants |
| Sex: Female, Male Male | 94 Participants | 107 Participants | 101 Participants | 302 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 173 / 200 | 189 / 202 | 182 / 200 |
| serious Total, serious adverse events | 8 / 200 | 5 / 202 | 3 / 200 |
Outcome results
Primary
Change in Pocket Depth.
Average change of Pocket Depth at 9 months from baseline
Time frame: baseline & 9 months
Population: Intent to treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Scaling and Root Planing + SHAM TX | Change in Pocket Depth. | -1.4 mm |
| Scaling and Root Planing + Periocline Gel | Change in Pocket Depth. | -1.6 mm |
| Scaling and Root Planing + Vehicle | Change in Pocket Depth. | -1.4 mm |