NCT02391974

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Teoxane SA · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-10-01
• Completion: 2017-07-01
• First posted: 2015-03-18
• Last updated: 2016-06-10

Locations

3 sites across 1 country: Germany