NCT02071199

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

February 21, 2014

Last Update Submit

November 28, 2016

Conditions

Gingivitis

Keywords

GingivitisPeriodontitisACCS

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse/serious adverse events

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

Secondary Outcomes (6)

  • Probing pocket depth

    Bseline and after two weeks of treatment

  • Modified gingival index

    Baseline and after two weeks of treatment

  • Bleeding on probing

    Baseline and after two weeks of treatment

  • Plaque index

    Baseline and after two weeks of treatment

  • Microbial analysis

    Baseline and after two weeks of treatment

  • +1 more secondary outcomes

Study Arms (3)

Low dose 0.3X ACCS

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

Drug: 0.3X ACCS

High dose 1X ACCS

EXPERIMENTAL

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

Drug: 1X ACCS (Amnion-derived Cellular Cytokine Solution)

Normal saline

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

Drug: Normal saline

Interventions

1X ACCS (Amnion-derived Cellular Cytokine Solution)DRUG

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

Also known as: ACCS
High dose 1X ACCS
Normal salineDRUG

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

Also known as: saline placebo
Normal saline
0.3X ACCSDRUG

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

Also known as: Diluted ACCS
Low dose 0.3X ACCS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forsyth Institute

Boston, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

GingivitisPeriodontitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • David L Steed, MD

    Noveome Biotherapeutics, formerly Stemnion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 25, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)