REFRAME RPD Post-Market Clinical Study

Subjects conducted the Oral Health-related Quality of Life (OHRQoL) before and after wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD). OHRQoL is a multidimensional survey which can be defined as a person's assessment of how functional, psychological, social factors, pain, or discomfort affect his/her well-being in the context of oral health. The purpose of the survey is to evaluate the change in these factors from wearing a cobalt chrome (CoCr) removable partial denture (RPD) to wearing the Solvay Dental 360™ polymer Removable Partial Denture (RPD).

This score is calculated by a summation of the score from each question; each having the following scoring:

Response Score Never 0 Points Hardly Ever 1 Point Occasionally 2 Points Fairly Often 3 Points Very Often 4 Points

It ranges from 0 to 56 points. The overall scores are from the baseline Cobalt Chrome (CoCr) RPD and 8 weeks for Polymer RPD. Lower scores are better outcomes.

To investigate the difference in health of the abutment teeth following the use of the polymer RPD as compared to the CoCr RPD as assessed by the plaque score and gingival bleeding index.

The plaque score is determined by assessing each tooth and the amount of plaque on the individual surfaces. The total number of plaque containing surfaces is divided by the total number of surfaces per arch of the mouth.

Arch plaque is a subset of the whole plaque score calculated as the number of arch surfaces with plaque divided by the number of arch surfaces assessed.

The gingival bleeding index is a designation of the degree of inflammation, as determined by a "bleeding on probing" assessment. Each tooth is probed at six sites and the bleeding is scored as present or absent. The number of sites where the bleeding is noted is divided by the total number of surfaces evaluated.

All assessments are expressed as a percentage and an increased percentage indicates a poorer patient outcome.

Operator assessment of the adaptation of the polymer frame, adaption of the tissue base areas and their relationship to the frame adaptation, functional evaluation, aesthetic assessment and oral health assessment of abutment teeth and the periodontium. This assessment was done with a Likert scale at baseline for the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) and visits 5, 6, 7 and 8 for the Solvay Dental 360™: Polymer Removable Partial Denture.

This assessment of aesthetics was determined by the operator based on a five point scale rating from very dissatisfied through very satisfied. More satisfied is a better outcome.

Patient-centered assessment of preference at the final visit for the study.

Patients were asked to choose their preference of Removable Partial Denture based on comfort, aesthetics and chewing. Preference for a specific denture is a better outcome.

This is an evaluation of the Solvay Dental 360™ Polymer Removable Partial Denture (RPD) for chips, cracks, fractures, permanent deformation or other signs mechanical failure. The number in the reported data represents a cumulative number of Solvay Dental 360™Polymer Removable Partial Denture (RPD) devices with these mechanical failures.

A device deficiency was defined as "the inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance."

Oral Health parameters associated with the Removable Partial Denture (RPD) on pocket depths based on Operator assessment.

Pocket depths are expressed in mm increments for mesial, mid, and distal locations on the lingual and buccal surfaces of the tooth. To measure pocket depth, a probe is placed beside the tooth beneath the gumline and indicates the groove between the gums and teeth. Visit 2 with the Cobalt Chrome (CoCr) Removable Partial Denture (RPD) is compared to visit 8 with the Solvay Dental 360™: Polymer Removable Partial Denture. In general, pocket depths of 1 to 3 mm indicate a healthy mouth and 4mm and greater may indicate periodontitis. The score is calculated as an average of all depths reported for all surfaces assessed.

A lower score is a better outcome.

Oral Health parameters associated with the Removable Partial Denture (RPD) abutment teeth and Removable Partial Denture (RPD): mobility (measured as a categorical value of either Class I, Class II or Class III).

Mobility of the teeth abutting the missing tooth as well as adjacent to the abutment tooth are classified via the Miller Classification as the following:

• Class I: Tooth can be moved less than 1mm in the buccolingual or mesiodistal direction; this included no mobility
• Class II: Tooth can be moved 1mm or more in the buccolingual or mesiodistal direction. No mobility in the occlusoapical direction (vertical mobility)
• Class III: Tooth can be moved 1mm or more in the buccolingual or mesiodistal direction. Mobility in the occlusoapical direction is also present

The mobility score assessment is noted as proportion of teeth that moved from a lower classification to a higher classification. Class I is a better outcome.

Oral Health parameters associated with the Solvay Dental 360™ Removable Partial Denture (RPD): mucosal bearing areas (measured as an evaluation of bleeding on probing indicated as a categorical value of "bleeding present" or "bleeding absent", as compared to the Cobalt Chrome (CoCr) Removable Partial Denture (RPD).

Operators were asked to rate the health of the mucosal bearing areas as poor, fair or good. The mucosal bearing area is the cushion between the denture base and the supporting bone. Good is a better outcome.