Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 6, 2018

Primary Completion Date

January 17, 2020

Study Completion Date

March 9, 2020

Conditions
Periodontal Diseases
Interventions
DEVICE

Periodontal Structure Repair (PSR)

Following local anesthesia, initial pocket preparation will be done by bur abrasion utilizing specially designed burs to plane the root surface and remove the inner lining of the pocket. Following bur abrasion, thin strips of gauze sponge are placed into the created space. After removing the gauze strips, PSR is inserted to fill the spaces beginning at the pocket bottom. The final step is placing a layer of cyanoacrylate on both the gingival margin and tooth supragingivally.

DEVICE

Standard Root Planing

Ultrasonics and hand instruments are used to remove any subgingival deposits on the roots. Standard instruments and standard application are used. Visual or instrument tactile inspection is used to verify the roots are hard-smooth and have been adequately cleaned.

Trial Locations (4)

27599

University of North Carolina at Chapel Hill School of Dentistry, Chapel Hill

35294

University of Alabama at Birmingham School of Dentistry, Birmingham

02142

Forsyth Institute, Cambridge

11794-8703

Stony Brook School of Dental Medicine, Stony Brook

All Listed Sponsors
lead

Periovance, Inc

INDUSTRY

NCT03671512 - Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease | Biotech Hunter | Biotech Hunter