Edentulous Jaw Clinical Trial
Official title:
Evaluation of Open-face Maxillary Complete Denture for Patients With Prominent Premaxilla. Crossover Study
Verified date | January 2024 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the present study was to evaluate open faced maxillary complete denture with soft acryl resin wing versus conventional heat cured maxillary complete denture regarding the retention and patient satisfaction.
Status | Completed |
Enrollment | 38 |
Est. completion date | October 5, 2023 |
Est. primary completion date | October 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 65 Years |
Eligibility | Inclusion Criteria: - Completely edentulous male patients. - Patients having had no previous complete dentures - Patients with well-developed edentulous ridge with proclined premaxilla covered with healthy firm mucosa - Patients with normal Angle Class 1 maxillomandibular relationship Exclusion Criteria: - Patients with resorbed ridges - Patients with xerostomia and patients undertaking medications that affect salivary flow (e.g., diuretics). Similarly, patients with systemic diseases that may affect the amount or consistency of saliva (e.g., uncontrolled diabetes mellitus). |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
haitham ahmed hassan ismail |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Denture retention | Evaluated using a universal testing machine to exert a vertical dislodging force on the denture. A stainless-steel loop was attached to the geometric center of the denture using autopolymerizing acrylic resin. The center of the labial frenum (point A) and the hamular notches (points B&C) were located in the denture base. The distance halfway between points B and C was measured, and the location was marked on the posterior border of the denture base (point D). Half the distance between points A and D was marked as the denture base center (point E). A force transmission device was used to transmit the dislodging vertical force from the universal testing machine to the denture. A facebow was used to set the Frankfort plane of the patient parallel to the floor. After orienting the participant to the testing machine, it was set to exert a dislodging force at a rate of 50 mm/min. The test was repeated 3 times for each denture and the mean was calculated. | up to 45 days | |
Primary | Patient satisfaction with esthetics | Participant satisfaction with esthetics was evaluated by using a Visual Analogue Scale (VAS). The level of satisfaction was indicated as a sign on a 10 cm VAS, labeled with (not at all satisfied) at the zero end with (completely satisfied) at the other end. The distance (mm) between the zero point and the sign marked by the patient on the 10-cm-line was measured and expressed in percentage. | up to 45 days | |
Primary | Patient satisfaction with comfort | Participant satisfaction with comfort was evaluated by using a Visual Analogue Scale (VAS). The level of satisfaction was indicated as a sign on a 10 cm VAS, labeled with (not at all satisfied) at the zero end with (completely satisfied) at the other end. The distance (mm) between the zero point and the sign marked by the patient on the 10-cm-line was measured and expressed in percentage. | up to 45 days |
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