Patient Satisfaction Clinical Trial
— BioHPPOfficial title:
BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible
NCT number | NCT05468983 |
Other study ID # | 686 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 21, 2018 |
Est. completion date | February 20, 2022 |
Verified date | July 2022 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The biggest challenge of oral rehabilitation is the replacement of lost structures and the restoration of their function and esthetics, focusing on matching a healthy tooth. Traditional complete dentures, implant (retained, supported) overdentures, and complete implant-supported fixed prostheses are all alternatives to the rehabilitation of the mandibular arch. The aim of this study was to compare BioHPP used as a skeletal substructure for hybrid (implant fixed, detachable) prostheses versus BioHPP bar supporting and retaining by using radiographic tracing to the marginal bone height changes around the implants, patient satisfaction can be improved.
Status | Completed |
Enrollment | 14 |
Est. completion date | February 20, 2022 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 55 Years to 65 Years |
Eligibility | Inclusion Criteria: 1- sufficient inter arch distance. 2. good oral hygiene. 3. Enough bone volume in interforaminal region. Exclusion Criteria: 1. TMJ disorders. 2. Radiotherapy or chemotherapy. 3. Diabetes mellitus 4. Uncooperative patients |
Country | Name | City | State |
---|---|---|---|
Egypt | Prosthodontics Department Faculty of Dentistry | Cairo | Ain Shames University |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bone height change around implants | The bone loss measurements were taken using a digital preapical radiograph as follows: Two horizontal lines were drawn at the alveolar bone crest and the implant apex; the software then automatically displays the measurements in millimeters between the two lines on the screen. Subtraction was used to compute the difference in bone height. The mean of the mesial and distal readings was calculated. The software then displays the measurements in millimeters between the two lines on the screen. At each follow-up visit, the values of linear measurements were recorded in the patient's chart, and the mean value of bone height change was calculated using this data. | from insertion ( base line) to 6 months ) , from 6 months to 12 months ,from 12 months to 18 months , from insertion to 12 months, from insertion to 18 months | |
Secondary | patient satisfactions | Patient satisfaction was evaluated using a questionnaire based on the visual analog scale (VAS). Patients were asked to mark their answers (amount of satisfaction). The questionnaire was given to the patients in Arabic.Six factors were rated on a 1 to 5 scale (highly satisfied = 5; satisfied = 4; fair = 3; dissatisfied = 2; highly dissatisfied = 1). The sum of the five sub-scores was then calculated, ranging from 5 to 30 (best score = 30, worst score = 5). The low range of scores indicated low satisfaction. | 6 months and 18 months |
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