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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Planin

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 Summary:

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.


Sponsor: Teoxane SA

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Pocket Probing Depth (PPD) [ Time Frame: Pre-injection, to 2, 5, 8 and 36 weeks after baseline ]
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)


Original Secondary Outcome: Same as current

Information By: Teoxane SA

Dates:
Date Received: March 12, 2015
Date Started: February 2015
Date Completion: July 2017
Last Updated: June 9, 2016
Last Verified: June 2016