PROH Network

Mouth rinse study

Rowpar Pharmaceuticals, Inc. has entered into a contract with OHSU to implement a research project being led by Theresa Madden, DDS, PhD. The company has a mouth rinse on the market that is currently being used as a breath freshener. The study will collect preliminary data as to the ability of the rinse to treat localized periodontitis.

One hundred sixteen patients will be enrolled in this double-blind, two arm trial. They will have at least 4 pockets with probe depth of 5mm or more and 2mm or more of attachment loss. Baseline data will be collected during the regular recall appointment and the mouth rinse will be applied with an ultrasonic scaler. The patient will use the rinse with an oral irrigator and as a mouthwash for 5 weeks. The patient will return to the office, have measurements and a plaque sample taken again, and return the unused materials.

The following data will be collected: date of birth, gender, smoking status, plaque index, gingivitis index, bleeding on probing, pocket depth, clinical attachment level, and compliance information. In addition, subgingival plaque samples will be taken.

The statistical analysis will include examining the distribution of each outcome variable graphically, identifying the appropriate distribution, and transforming the data if necessary. Generalized estimating equations will be used to account for correlations due to measurements taken at multiple sites and time points from the same subject.