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This study evaluates the efficacy and safety of Periodontal Structure Repair device (PRS) compared to conventional periodontal therapy (scaling and root planing) for the treatment of periodontal pockets caused by periodontal disease.
This is a multicenter, prospective, randomized, open, active comparator-controlled study with a parallel group, subject-paired design (i.e. the effect of both treatments can be observed in the same subject).
Subjects must have two quadrants of their mouth that each have at least two teeth with one or more pockets per tooth that are 5-8 mm in depth. Subjects having more than 2 quadrants will have the first 2 quadrants randomized to receive two different treatments (one quadrant root planing and one quadrant PSR procedure) from the group of available quadrants.
Investigators will assess the efficacy of the Periodontal Structure Repair device (PRS) as measured by a reduction in pocket depth.
Periodontal Structure Repair (PRS), Standard Root Planing
Not yet recruiting
Published on BioPortfolio: 2018-09-19T05:14:17-0400
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Removal or disruption of DENTAL DEPOSITS and plaque-retentive DENTAL CALCULUS from tooth surfaces and within the periodontal pocket space without deliberate removal of CEMENTUM as done in ROOT PLANING and often in DENTAL SCALING. The goal is to conserve dental cementum to help maintain or re-establish healthy periodontal environment and eliminate PERIODONTITIS by using light instrumentation strokes and nonsurgical techniques (e.g., ultrasonic, laser instruments).
Loss or destruction of periodontal tissue caused by periodontitis or other destructive periodontal diseases or by injury during instrumentation. Attachment refers to the periodontal ligament which attaches to the alveolar bone. It has been hypothesized that treatment of the underlying periodontal disease and the seeding of periodontal ligament cells enable the creating of new attachment.
A procedure for smoothing of the roughened root surface or cementum of a tooth after subgingival curettage or scaling, as part of periodontal therapy.
Any restorative and replacement device that is used as a therapeutic aid in the treatment of periodontal disease. It is an adjunct to other forms of periodontal therapy and does not cure periodontal disease by itself. (Boucher's Clinical Dental Terminology, 3d ed)
Techniques for enhancing and directing cell growth to repopulate specific parts of the PERIODONTIUM that have been damaged by PERIODONTAL DISEASES; TOOTH DISEASES; or TRAUMA, or to correct TOOTH ABNORMALITIES. Repopulation and repair is achieved by guiding the progenitor cells to reproduce in the desired location by blocking contact with surrounding tissue by use of membranes composed of synthetic or natural material that may include growth inducing factors as well.
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