Overview

This trial has been completed.

Condition gingivitis
Treatments 1x accs (amnion-derived cellular cytokine solution), normal saline, 0.3x accs
Phase phase 1
Sponsor Noveome Biotherapeutics, formerly Stemnion
Start date March 2014
End date October 2015
Trial size 54 participants
Trial identifier NCT02071199, ST-04-13

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
20 microliters of 0.3X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
0.3x accs Diluted ACCS
0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
(Experimental)
20 microliters of 1X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
1x accs (amnion-derived cellular cytokine solution) ACCS
1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
(Placebo Comparator)
20 microliters of saline placebo per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
normal saline saline placebo
Saline will be applied to the gingival margin daily 5 days per week for 2 weeks

Primary Outcomes

Measure
Incidence of adverse/serious adverse events
time frame: End of two weeks of treatment and at two weeks follow-up visit

Secondary Outcomes

Measure
Probing pocket depth
time frame: Bseline and after two weeks of treatment
Modified gingival index
time frame: Baseline and after two weeks of treatment
Bleeding on probing
time frame: Baseline and after two weeks of treatment
Plaque index
time frame: Baseline and after two weeks of treatment
Microbial analysis
time frame: Baseline and after two weeks of treatment
Cytokine analysis
time frame: Baseline and after two weeks of therapy

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Noveome Biotherapeutics, formerly Stemnion.