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

Primary Purpose

Gingivitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

1X ACCS (Amnion-derived Cellular Cytokine Solution)

Normal saline

0.3X ACCS

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis, Periodontitis, ACCS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Forsyth Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Low dose 0.3X ACCS

High dose 1X ACCS

Normal saline

Arm 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

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

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

Outcomes

Primary Outcome Measures

Incidence of adverse/serious adverse events

Secondary Outcome Measures

Probing pocket depth

Depth will be measured at six sites per tooth

Modified gingival index

Gingival index will be measured at six sites per tooth

Bleeding on probing

Bleeding will be measured at six sites per tooth

Plaque index

Only the gingival third of the tooth will be evaluated

Microbial analysis

6 teeth will be sampled

Cytokine analysis

Inflammatory cytokines will be sampled in crevicular fluid

Full Information

NCT ID

NCT02071199

First Posted

February 21, 2014

Last Updated

November 28, 2016

Sponsor

Noveome Biotherapeutics, formerly Stemnion

1. Study Identification

Unique Protocol Identification Number

NCT02071199

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Noveome Biotherapeutics, formerly Stemnion

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis

Keywords

Gingivitis, Periodontitis, ACCS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose 0.3X ACCS

Arm Type

Experimental

Arm 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

Arm Title

High dose 1X ACCS

Arm Type

Experimental

Arm Description

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

Arm Title

Normal saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

1X ACCS (Amnion-derived Cellular Cytokine Solution)

Other Intervention Name(s)

ACCS

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

saline placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.3X ACCS

Other Intervention Name(s)

Diluted ACCS

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse/serious adverse events

Time Frame

End of two weeks of treatment and at two weeks follow-up visit

Secondary Outcome Measure Information:

Title

Probing pocket depth

Description

Depth will be measured at six sites per tooth

Time Frame

Bseline and after two weeks of treatment

Title

Modified gingival index

Description

Gingival index will be measured at six sites per tooth

Time Frame

Baseline and after two weeks of treatment

Title

Bleeding on probing

Description

Bleeding will be measured at six sites per tooth

Time Frame

Baseline and after two weeks of treatment

Title

Plaque index

Description

Only the gingival third of the tooth will be evaluated

Time Frame

Baseline and after two weeks of treatment

Title

Microbial analysis

Description

6 teeth will be sampled

Time Frame

Baseline and after two weeks of treatment

Title

Cytokine analysis

Description

Inflammatory cytokines will be sampled in crevicular fluid

Time Frame

Baseline and after two weeks of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David L Steed, MD

Organizational Affiliation

Noveome Biotherapeutics, formerly Stemnion

Official's Role

Study Director

Facility Information:

Facility Name

Forsyth Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02142

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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