search
Back to results

Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis

Primary Purpose

Periodontal Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ST266
Saline (0.9% NaCl)
Sponsored by
Noveome Biotherapeutics, formerly Stemnion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of signed, written informed consent prior to participation in any study-related procedures.
  • Good general health as evidenced by medical history.
  • Between 18 and 85 years of age at time of informed consent signature.
  • Male or female.
  • Minimum of 18 teeth, excluding third molars.
  • Having moderate to severe periodontal disease according to AAP definition (at least 6 teeth ≥6 mm PD and ≥3 mm CAL at baseline).
  • Having >30 percent bleeding sites upon probing.
  • Willing to abstain from chewing gums and other mouth rinses for the study duration.
  • Ability and willingness to attend all study visits and comply with all study visits and comply with all study procedures and requirements.
  • Willingness to abstain from routine dental care.
  • For women with reproductive potential, willingness to use highly effective contraception (e.g. licensed hormonal contraception, intrauterine device, abstinence, or vasectomy in partner).

Exclusion Criteria:

  • Presence of orthodontic appliances.
  • A soft or hard tissue tumor of the oral cavity.
  • Any dental condition that requires immediate treatment, such as carious lesions.
  • Participation in any other clinical study within 30 days of screening or during the study.
  • Pregnancy or lactation. If a subject meets this criterion, she may be rescreened for study participation when she no longer meets this criterion.
  • Antibiotic therapy within the last 30 days.
  • Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti inflammatory drugs, steroids). Low-dose aspirin (less than 325 mg daily) is allowed.
  • Immunocompromised subjects.
  • Subjects with cancer or a history of cancer within the last 5 years of screening.
  • Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as diabetes, nifedipine, phenytoin (Dilantin), or anticoagulant medications (e.g., warfarin [Coumadin] etc.).
  • Involvement in the planning or conduct of the study.
  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or interfere with interpretation of the subject's study results.
  • Previous randomization for treatment in the present study

Sites / Locations

  • University of Alabama at Birmingham School of Dentistry
  • Oral Health Research Institute
  • Forsyth Institute
  • Columbia University College of Dental Medicine
  • Stony Brook School of Dental Medicine
  • University of North Carolina at Chapel Hill School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).

Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).

Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.

Outcomes

Primary Outcome Measures

Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline
The primary efficacy endpoint of this study is the change from baseline in the PD at 9 months (Day 270) for those pockets ≥6 mm at baseline.

Secondary Outcome Measures

Changes in Clinical Attachment Level (CAL)
Change in Clinical Attachment Level (CAL) (the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ) that is a fixed point, using probing depth and the distance from the gingival margin to the CEJ.) from baseline in CAL at 9 months (Day 270) in tooth sites with baseline PD ≥ 6mm.
Bleeding on Probing (BOP)
A secondary efficacy endpoint of this study is change from baseline in BOP at 9 months (Day 270) with BOP for each subject calculated as the percentage of tooth sites in the whole mouth with BOP.

Full Information

First Posted
April 21, 2016
Last Updated
July 1, 2021
Sponsor
Noveome Biotherapeutics, formerly Stemnion
search

1. Study Identification

Unique Protocol Identification Number
NCT02761993
Brief Title
Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Treatment Regimen of ST266 in Subjects With Moderate to Severe Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noveome Biotherapeutics, formerly Stemnion

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal disease.
Detailed Description
The study is a 9-month, randomized, double-blind, parallel-design study of subjects with existing moderate to severe periodontal disease randomly assigned to one of three groups. The primary endpoint of PD change will be evaluated following 9 months of treatment. Subjects will be followed for 9 months for safety and radiographic evaluations. Subjects who meet inclusion criteria will be randomized to one of three treatment groups. Randomization will be stratified by site and smoker status (never smoked or quit smoking more than two years ago vs. has smoked within the last two years). Randomization will be blocked such that assignment to treatment groups both within sites and within smoker status will be approximately even (1:1:1). Treatment will be initiated after SRP. All subjects will be evaluated at baseline and Days 1, 15, 30, 60, 90, 180, and 270.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Description
Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.
Intervention Type
Biological
Intervention Name(s)
ST266
Intervention Description
1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
Intervention Type
Drug
Intervention Name(s)
Saline (0.9% NaCl)
Intervention Description
Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
Primary Outcome Measure Information:
Title
Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline
Description
The primary efficacy endpoint of this study is the change from baseline in the PD at 9 months (Day 270) for those pockets ≥6 mm at baseline.
Time Frame
Baseline; 9 months
Secondary Outcome Measure Information:
Title
Changes in Clinical Attachment Level (CAL)
Description
Change in Clinical Attachment Level (CAL) (the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ) that is a fixed point, using probing depth and the distance from the gingival margin to the CEJ.) from baseline in CAL at 9 months (Day 270) in tooth sites with baseline PD ≥ 6mm.
Time Frame
Baseline, 9 months
Title
Bleeding on Probing (BOP)
Description
A secondary efficacy endpoint of this study is change from baseline in BOP at 9 months (Day 270) with BOP for each subject calculated as the percentage of tooth sites in the whole mouth with BOP.
Time Frame
Baseline and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed, written informed consent prior to participation in any study-related procedures. Good general health as evidenced by medical history. Between 18 and 85 years of age at time of informed consent signature. Male or female. Minimum of 18 teeth, excluding third molars. Having moderate to severe periodontal disease according to AAP definition (at least 6 teeth ≥6 mm PD and ≥3 mm CAL at baseline). Having >30 percent bleeding sites upon probing. Willing to abstain from chewing gums and other mouth rinses for the study duration. Ability and willingness to attend all study visits and comply with all study visits and comply with all study procedures and requirements. Willingness to abstain from routine dental care. For women with reproductive potential, willingness to use highly effective contraception (e.g. licensed hormonal contraception, intrauterine device, abstinence, or vasectomy in partner). Exclusion Criteria: Presence of orthodontic appliances. A soft or hard tissue tumor of the oral cavity. Any dental condition that requires immediate treatment, such as carious lesions. Participation in any other clinical study within 30 days of screening or during the study. Pregnancy or lactation. If a subject meets this criterion, she may be rescreened for study participation when she no longer meets this criterion. Antibiotic therapy within the last 30 days. Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti inflammatory drugs, steroids). Low-dose aspirin (less than 325 mg daily) is allowed. Immunocompromised subjects. Subjects with cancer or a history of cancer within the last 5 years of screening. Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as diabetes, nifedipine, phenytoin (Dilantin), or anticoagulant medications (e.g., warfarin [Coumadin] etc.). Involvement in the planning or conduct of the study. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or interfere with interpretation of the subject's study results. Previous randomization for treatment in the present study
Facility Information:
Facility Name
University of Alabama at Birmingham School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Oral Health Research Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Forsyth Institute
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
Facility Name
Columbia University College of Dental Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Stony Brook School of Dental Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8703
Country
United States
Facility Name
University of North Carolina at Chapel Hill School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis

We'll reach out to this number within 24 hrs