Treatment of Human Gingivitis With Amnion-derived Cellular Cytokine Solution (ACCS)

Noveome Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Gingivitis

Treatments: Drug: 0.3X ACCS; Drug: Normal saline; Drug: 1X ACCS (Amnion-derived Cellular Cytokine Solution)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02071199

ST-04-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

Low dose 0.3X ACCS

Experimental group

Description:

20 microliters of 0.3X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks

Treatment:

Drug: 0.3X ACCS

High dose 1X ACCS

Experimental group

Description:

20 microliters of 1X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks

Treatment:

Drug: 1X ACCS (Amnion-derived Cellular Cytokine Solution)

Normal saline

Placebo Comparator group

Description:

20 microliters of saline placebo per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks

Treatment:

Drug: Normal saline