NCT02391974

Brief Summary

This is a controlled, randomized, single-blinded, multicenter, prospective clinical study. In addition to the standard periodontal treatment procedure on all teeth that need to be treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone. The pocket depth will be measured at six sites around each tooth, and only the deepest pocket sites of each tooth will be taken into account.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

March 12, 2015

Last Update Submit

June 9, 2016

Conditions

Chronic Periodontitis

Keywords

Hyaluronic acidPeriodontal pocketsPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in Pocket Probing Depth (PPD)

    PPD is defined as the distance from the gingival margin to the base of the gingival crevice, i.e. the bottom of the clinical pocket. PPD will be measured at six sites per tooth (DV, V, MV, DL, L, ML), using a constant-force computerized periodontal probe with a 0.2 mm precision. Only the deepest will be taken into account

    Pre-injection, to 12, 24 and 48 weeks after baseline

Secondary Outcomes (12)

  • Change in Pocket Probing Depth (PPD)

    Pre-injection, to 2, 5, 8 and 36 weeks after baseline

  • Change in Clinical Attachment Level (CAL)

    Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

  • Bleeding On Probing (BOP)

    Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

  • Tooth Mobility

    Pre-injection, to 12, 24, 36 and 48 weeks after baseline

  • Plaque Index (PI)

    Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline

  • +7 more secondary outcomes

Study Arms (2)

PERIOSYAL FILL

EXPERIMENTAL

n=15

Device: PERIOSYAL FILL

No treatment (untreated control)

NO INTERVENTION

n=15

Interventions

PERIOSYAL FILLDEVICE

Injection 2 weeks after standard periodontal treatment procedure on all teeth that need to be treated. Touch-up treatment provided at 3 and 6 weeks.

PERIOSYAL FILL

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women, aged between 25 and 60 years
  • Patients with at least 20 natural teeth
  • Patient with periodontitis confirmed by a X-ray diagnosis, and having at least 4 teeth with periodontal pockets with probing depth between 4 and 6 mm
  • Willing to understand and comply with study requirements and to sign informed consent

You may not qualify if:

  • Patient with an active smoking status
  • Patient with an antibiotic therapy within the previous 4 weeks
  • Need for continuous medical treatment within 2 weeks prior to enrollment
  • Ongoing inflammatory state or a systemic illness that may affect the oral cavity
  • Patient with hypofunction in saliva productions (e.g. Sjögren Syndrome with Xerostomia)
  • History of active chronic debiliating systemic disease, including insulin or non-insulin dependent diabetes
  • Patients with bleeding disorders
  • History of allergies to gram positive bacterial proteins
  • History of hypersensitivity and/or idiosyncrasies to any of the test compounds, e.g. hyaluronic acid or other device compounds
  • History of multiple severe allergies, history of anaphylactic shock
  • History of connective tissue disease (rheumatoid arthritis, scleroderma, systemic lupus erythematosus) or of any other autoimmunity disease
  • History of herpetic lesion or lichen planus
  • Pregnant or breast feeding women, or female subjects of childbearing potential who did not intend to practice medically acceptable method of contraception
  • Participation in another clinical study in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dental Specialist

Düsseldorf, Germany

RECRUITING

Dr. Wahlmann & Partner

Edewecht, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontal PocketPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 18, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

July 1, 2017

Last Updated

June 10, 2016

Record last verified: 2016-06

Locations

DE(3)