Back to resultsEfficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
PERIOSYAL FILL
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Hyaluronic acid, Periodontal pockets, Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Dental SpecialistRecruiting
- Dr. Wahlmann & PartnerRecruiting
- Universitätsklinikum Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PERIOSYAL FILL
No treatment (untreated control)
Arm Description
n=15
n=15
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Pocket Probing Depth (PPD)
Change in Clinical Attachment Level (CAL)
CAL is defined as the distance from the Cemento-Enamel Junction (CEJ) to the base of the probable crevice/pocket (the bottom of the clinical pocket)
Bleeding On Probing (BOP)
BOP is defined as presence/absence of bleeding within 15 seconds following pocket probing
Tooth Mobility
Tooth Mobility will be assessed on the scale defined by Muehlemann
Plaque Index (PI)
PI will be measured for each tooth using the four-point scale Silness and Löe Plaque Index
Gingival Index (GI)
GI will be measured for each tooth using the four-point scale Silness and Löe Gingival Index
Oral Health-related quality of life
Oral Health-related quality of life is a patient reported outcome measure specifically pertaining to oral health capturing both the functional, social and psychological impacts of oral disease, assessed using the OHQoL-GE, a validated translation of the OHQoL-UK
Microbiological analysis of the 11 main periodontal pathogens
Periodontal pathogens will be measured using micro-IDent plus 1/11 Hain tests, a noninvasive saliva prelevement using paper points
Physician satisfaction with the treatment
Satisfaction will be assessed on a 5-grade subjective symmetrical scale
Subject Satisfaction with the treatment
Satisfaction will be assessed on a 5-grade subjective symmetrical scale
Total volume of product injected in each of the included teeth
Volume will be measured to an accuracy of 0.025 mL
Pain felt by the patient in the aera (tooth, gum)
Pain will be self-assessed by the subject on each included teeth using a 100 mm Visual Analog Scale (VAS)
Full Information
NCT ID
NCT02391974
First Posted
March 12, 2015
Last Updated
June 9, 2016
Sponsor
Teoxane SA
Collaborators
Syneed Medidata GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02391974
Brief Title
Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets
Official Title
Filling of Periodontal Pockets With a Commercially Available Injectable Cross-linked Hyaluronic Acid Dental Filler Versus Oral Hygiene Alone, After Scaling and Root Planing and Chlorhexidine Disinfection, for the Treatment of Periodontitis: A Single-blinded, Multi Center, Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teoxane SA
Collaborators
Syneed Medidata GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a controlled, randomized, single-blinded (independent Blinded Evaluator), multicenter, prospective clinical study.
Each subject will receive the standard periodontal treatment procedure on all teeth that need to be treated. The usual cares are scaling and root planing (SRP), and chlorhexidine, and instructions to oral hygiene (proper brushing techniques twice a day, proper flossing technique daily, and prevention : sugar intake, alcohol consumption, fluoride level).
Two other optional treatment sessions with SRP could be performed, if deemed necessary by the Treating Investigator. Those optional SRP session could only be performed after all study-related clinical assessement.
The pocket depth of every teeth will be measured at six sites around each tooth, and only the deepest pocket sites will be taken into account. The 4 teeth with the deepest pockets will be included in the study and randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Hyaluronic acid, Periodontal pockets, Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PERIOSYAL FILL
Arm Type
Experimental
Arm Description
n=15
Arm Title
No treatment (untreated control)
Arm Type
No Intervention
Arm Description
n=15
Intervention Type
Device
Intervention Name(s)
PERIOSYAL FILL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pocket Probing Depth (PPD)
Description
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
Time Frame
Pre-injection, to 12, 24 and 48 weeks after baseline
Secondary Outcome Measure Information:
Title
Change in Pocket Probing Depth (PPD)
Time Frame
Pre-injection, to 2, 5, 8 and 36 weeks after baseline
Title
Change in Clinical Attachment Level (CAL)
Description
CAL is defined as the distance from the Cemento-Enamel Junction (CEJ) to the base of the probable crevice/pocket (the bottom of the clinical pocket)
Time Frame
Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
Title
Bleeding On Probing (BOP)
Description
BOP is defined as presence/absence of bleeding within 15 seconds following pocket probing
Time Frame
Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
Title
Tooth Mobility
Description
Tooth Mobility will be assessed on the scale defined by Muehlemann
Time Frame
Pre-injection, to 12, 24, 36 and 48 weeks after baseline
Title
Plaque Index (PI)
Description
PI will be measured for each tooth using the four-point scale Silness and Löe Plaque Index
Time Frame
Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
Title
Gingival Index (GI)
Description
GI will be measured for each tooth using the four-point scale Silness and Löe Gingival Index
Time Frame
Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
Title
Oral Health-related quality of life
Description
Oral Health-related quality of life is a patient reported outcome measure specifically pertaining to oral health capturing both the functional, social and psychological impacts of oral disease, assessed using the OHQoL-GE, a validated translation of the OHQoL-UK
Time Frame
Pre-injection, to 12, 24, 36 and 48 weeks after baseline
Title
Microbiological analysis of the 11 main periodontal pathogens
Description
Periodontal pathogens will be measured using micro-IDent plus 1/11 Hain tests, a noninvasive saliva prelevement using paper points
Time Frame
: Pre-injection, to 12, 24, 36 and 48 weeks after baseline
Title
Physician satisfaction with the treatment
Description
Satisfaction will be assessed on a 5-grade subjective symmetrical scale
Time Frame
12, 24, 36 and 48 weeks after baseline
Title
Subject Satisfaction with the treatment
Description
Satisfaction will be assessed on a 5-grade subjective symmetrical scale
Time Frame
12, 24, 36 and 48 weeks after baseline
Title
Total volume of product injected in each of the included teeth
Description
Volume will be measured to an accuracy of 0.025 mL
Time Frame
during each injection session
Title
Pain felt by the patient in the aera (tooth, gum)
Description
Pain will be self-assessed by the subject on each included teeth using a 100 mm Visual Analog Scale (VAS)
Time Frame
Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Dental Specialist
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcel WAINWRIGHT
Email
wainwright@dentalspecialists.de
First Name & Middle Initial & Last Name & Degree
Marcel WAINWRIGHT
Facility Name
Dr. Wahlmann & Partner
City
Edewecht
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen WAHLMANN
Email
dr.wahlmann@web.de
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf SMEETS
Email
r.smeets@uke.de
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets
We'll reach out to this number within 24 hrs