Gingivitis
Conditions
Keywords
Gingivitis, Periodontitis, ACCS
Brief summary
The purpose of this study is to evaluate the safety of oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis
Detailed description
This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two doses of ACCS will be used. It will be given topically intra-orally daily Monday through Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by random chance. If there are no safety issues, cohort two will include a higher dose of ACCS randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative microbial analysis will be performed for common oral bacteria. There will also be an analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the study. Comparisons of adverse events and outcomes will be made between the subjects receiving low dose ACCS, high dose ACCS, and saline.
Interventions
DRUG1X ACCS (Amnion-derived Cellular Cytokine Solution)
1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
DRUGNormal saline
Saline will be applied to the gingival margin daily 5 days per week for 2 weeks
DRUG0.3X ACCS
0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
Sponsors
Noveome Biotherapeutics, formerly Stemnion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* good general health * ages 18-70 years * minimum of 20 natural teeth * modified gingival index score of 2.0 or greater and \>40 percent bleeding sites at initial presentation.
Exclusion criteria
* presence of orthodontic appliance * soft or hard tissue tumor of the oral cavity * carious lesion requiring immediate treatment * participation in another clinical trial within 30 days * pregnant or breast-feeding women * women of child-bearing potential refusing to use an acceptable method of birth control * antibiotic therapy within the last 30 days * chronic use (\> 3 times/week) of non-steroidal anti-inflammatory medications (NSAID). Any use of steroids. Low dose (\<325 mg) aspirin is allowed. * immune-compromised subjects * subjects with liver or kidney dysfunction on blood tests as evidenced by a value equal to or greater than 2X the upper limit of normal. * any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues such as diabetes rheumatoid arthritis, Crohn's disease, use of nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g. warfarin), ongoing cancer treatment either with radiation of chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse/serious adverse events | End of two weeks of treatment and at two weeks follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified gingival index | Baseline and after two weeks of treatment | Gingival index will be measured at six sites per tooth |
| Bleeding on probing | Baseline and after two weeks of treatment | Bleeding will be measured at six sites per tooth |
| Probing pocket depth | Bseline and after two weeks of treatment | Depth will be measured at six sites per tooth |
| Microbial analysis | Baseline and after two weeks of treatment | 6 teeth will be sampled |
| Cytokine analysis | Baseline and after two weeks of therapy | Inflammatory cytokines will be sampled in crevicular fluid |
| Plaque index | Baseline and after two weeks of treatment | Only the gingival third of the tooth will be evaluated |
Countries
United States
Outcome results
None listed