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Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02391974
Recruitment Status : Unknown
Verified June 2016 by Teoxane SA.
Recruitment status was:  Recruiting
First Posted : March 18, 2015
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
Syneed Medidata GmbH
Information provided by (Responsible Party):
Teoxane SA

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Device: PERIOSYAL FILL Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: PERIOSYAL FILL
n=15
Device: PERIOSYAL FILL

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.


No Intervention: No treatment (untreated control)
n=15



Primary Outcome Measures :
  1. Change in Pocket Probing Depth (PPD) [ Time Frame: Pre-injection, to 12, 24 and 48 weeks after baseline ]
    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 :
  1. Change in Pocket Probing Depth (PPD) [ Time Frame: Pre-injection, to 2, 5, 8 and 36 weeks after baseline ]
  2. Change in Clinical Attachment Level (CAL) [ Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline ]
    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)

  3. Bleeding On Probing (BOP) [ Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline ]
    BOP is defined as presence/absence of bleeding within 15 seconds following pocket probing

  4. Tooth Mobility [ Time Frame: Pre-injection, to 12, 24, 36 and 48 weeks after baseline ]
    Tooth Mobility will be assessed on the scale defined by Muehlemann

  5. Plaque Index (PI) [ Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline ]
    PI will be measured for each tooth using the four-point scale Silness and Löe Plaque Index

  6. Gingival Index (GI) [ Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline ]
    GI will be measured for each tooth using the four-point scale Silness and Löe Gingival Index

  7. Oral Health-related quality of life [ Time Frame: Pre-injection, to 12, 24, 36 and 48 weeks after baseline ]
    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

  8. Microbiological analysis of the 11 main periodontal pathogens [ Time Frame: : Pre-injection, to 12, 24, 36 and 48 weeks after baseline ]
    Periodontal pathogens will be measured using micro-IDent plus 1/11 Hain tests, a noninvasive saliva prelevement using paper points

  9. Physician satisfaction with the treatment [ Time Frame: 12, 24, 36 and 48 weeks after baseline ]
    Satisfaction will be assessed on a 5-grade subjective symmetrical scale

  10. Subject Satisfaction with the treatment [ Time Frame: 12, 24, 36 and 48 weeks after baseline ]
    Satisfaction will be assessed on a 5-grade subjective symmetrical scale

  11. Total volume of product injected in each of the included teeth [ Time Frame: during each injection session ]
    Volume will be measured to an accuracy of 0.025 mL

  12. Pain felt by the patient in the aera (tooth, gum) [ Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline ]
    Pain will be self-assessed by the subject on each included teeth using a 100 mm Visual Analog Scale (VAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391974


Locations
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Germany
Dental Specialist Recruiting
Düsseldorf, Germany
Contact: Marcel WAINWRIGHT       wainwright@dentalspecialists.de   
Principal Investigator: Marcel WAINWRIGHT         
Dr. Wahlmann & Partner Recruiting
Edewecht, Germany
Contact: Jürgen WAHLMANN       dr.wahlmann@web.de   
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Ralf SMEETS       r.smeets@uke.de   
Sponsors and Collaborators
Teoxane SA
Syneed Medidata GmbH

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Responsible Party: Teoxane SA
ClinicalTrials.gov Identifier: NCT02391974     History of Changes
Other Study ID Numbers: TEO-PER-1401
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016

Keywords provided by Teoxane SA:
Hyaluronic acid
Periodontal pockets
Periodontitis

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Pocket
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents