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

Phase 1

Completed

• Conditions: Gingivitis
• Interventions: Drug: 0.3X ACCS; Drug: 1X ACCS (Amnion-derived Cellular Cytokine Solution); Drug: Normal saline

• Registration Number: NCT02071199
• Lead Sponsor: Noveome Biotherapeutics, formerly Stemnion

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.

Study Timeline

• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Study Start: 2014-03
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose 0.3X ACCS	0.3X ACCS	20 microliters of 0.3X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
High dose 1X ACCS	1X ACCS (Amnion-derived Cellular Cytokine Solution)	20 microliters of 1X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
Normal saline	Normal saline	20 microliters of saline placebo per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks

Primary Outcome Measures

Name	Time	Method
Incidence of adverse/serious adverse events	End of two weeks of treatment and at two weeks follow-up visit

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth	Bseline and after two weeks of treatment	Depth will be measured at six sites per tooth
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
Plaque index	Baseline and after two weeks of treatment	Only the gingival third of the tooth will be evaluated
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

Trial Locations

Locations (1)

Forsyth Institute; 🇺🇸 Boston, Massachusetts, United States