MedDataX Logo

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

NCT ID: NCT02071199

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Gingivitis Periodontitis ACCS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low dose 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

Group Type EXPERIMENTAL

0.3X ACCS

Intervention Type DRUG

0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks

High dose 1X ACCS

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

Group Type EXPERIMENTAL

1X ACCS (Amnion-derived Cellular Cytokine Solution)

Intervention Type DRUG

1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Saline will be applied to the gingival margin daily 5 days per week for 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1X ACCS (Amnion-derived Cellular Cytokine Solution)

1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks

Intervention Type DRUG

Normal saline

Saline will be applied to the gingival margin daily 5 days per week for 2 weeks

Intervention Type DRUG

0.3X ACCS

0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ACCS saline placebo Diluted ACCS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Noveome Biotherapeutics, formerly Stemnion

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David L Steed, MD

Role: STUDY_DIRECTOR

Noveome Biotherapeutics, formerly Stemnion

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Forsyth Institute

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ST-04-13

Identifier Type: -

Identifier Source: org_study_id