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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02391974
• Other study ID #: TEO-PER-1401
• Status: Recruiting
• Phase: Phase 4
• First received: March 12, 2015
• Last updated: June 9, 2016
• Start date: February 2015
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: Teoxane SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontal Pocket
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Germany	Dental Specialist	Düsseldorf
Germany	Dr. Wahlmann & Partner	Edewecht
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Teoxane SA	Syneed Medidata GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Pocket Probing Depth (PPD)		Pre-injection, to 2, 5, 8 and 36 weeks after baseline	No
Secondary	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)	Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline	No
Secondary	Bleeding On Probing (BOP)	BOP is defined as presence/absence of bleeding within 15 seconds following pocket probing	Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline	No
Secondary	Tooth Mobility	Tooth Mobility will be assessed on the scale defined by Muehlemann	Pre-injection, to 12, 24, 36 and 48 weeks after baseline	No
Secondary	Plaque Index (PI)	PI will be measured for each tooth using the four-point scale Silness and Löe Plaque Index	Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline	No
Secondary	Gingival Index (GI)	GI will be measured for each tooth using the four-point scale Silness and Löe Gingival Index	Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline	No
Secondary	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	Pre-injection, to 12, 24, 36 and 48 weeks after baseline	No
Secondary	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	: Pre-injection, to 12, 24, 36 and 48 weeks after baseline	No
Secondary	Physician satisfaction with the treatment	Satisfaction will be assessed on a 5-grade subjective symmetrical scale	12, 24, 36 and 48 weeks after baseline	No
Secondary	Subject Satisfaction with the treatment	Satisfaction will be assessed on a 5-grade subjective symmetrical scale	12, 24, 36 and 48 weeks after baseline	No
Secondary	Total volume of product injected in each of the included teeth	Volume will be measured to an accuracy of 0.025 mL	during each injection session	No
Secondary	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)	Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline	Yes