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

Gingivitis Clinical Trial

Official title:

Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071199
• Other study ID #: ST-04-13
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2014
• Last updated: November 28, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Noveome Biotherapeutics, formerly Stemnion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• 1X ACCS (Amnion-derived Cellular Cytokine Solution)
1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
• Normal saline
Saline will be applied to the gingival margin daily 5 days per week for 2 weeks
• 0.3X ACCS
0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks

Locations

Country	Name	City	State
United States	Forsyth Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Noveome Biotherapeutics, formerly Stemnion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse/serious adverse events		End of two weeks of treatment and at two weeks follow-up visit	Yes
Secondary	Probing pocket depth	Depth will be measured at six sites per tooth	Bseline and after two weeks of treatment	No
Secondary	Modified gingival index	Gingival index will be measured at six sites per tooth	Baseline and after two weeks of treatment	No
Secondary	Bleeding on probing	Bleeding will be measured at six sites per tooth	Baseline and after two weeks of treatment	No
Secondary	Plaque index	Only the gingival third of the tooth will be evaluated	Baseline and after two weeks of treatment	No
Secondary	Microbial analysis	6 teeth will be sampled	Baseline and after two weeks of treatment	No
Secondary	Cytokine analysis	Inflammatory cytokines will be sampled in crevicular fluid	Baseline and after two weeks of therapy	No