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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05321589
Other study ID # A25100221
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date March 20, 2022

Study information

Verified date April 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla.


Description:

Each patient received 6 implants in the maxillary ridge (widely distributed across the arch) in the following positions: central incisors, canines/first premolar teeth and first molar teeth aided by surgical stent. then each patient received 2 types of impression techniques Technique 1 :conventional impression conventional open tray impression technique with splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using original scan bodies torqued to the implants .three dimensional accuracy of impression techniques was evaluated using linear measurements and 3D deviation between the two techniques was measured.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 20, 2022
Est. primary completion date February 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria: - The patients were selected according to the following inclusion criteria: 1. Completely edentulous maxillary and mandibular ridges 2. Healthy ridge covered by normal oral mucosa and free from any ridge flabbiness. 3. All of the patients were dissatisfied with the retention and stability of their maxillary conventional dentures and expressed a strong desire for a more stable prosthesis. 4. Sufficient bone quantity and quality in the front and posterior maxillary regions, as determined by preoperative CBCT, to accommodate six implants with a diameter of at least 3.5 mm and a length of at least 10 mm. 5. Enough restorative space (from the mucosa covering the crest of the maxillary residual ridge to the occlusal plane) to allow the fixed prosthesis to be constructed ,preliminary jaw relationship revealed this. 6. It's been at least a year since the last extraction. Exclusion Criteria: 1. Systemic diseases that may alter tissue response to implantation and affects osseointegration (radiation, diabetes, osteoporosis, bleeding disorders or hepatic patients) 2. Long term immunosuppressive and corticosteroid drug therapy. 3. Patient with abnormal habits as clenching and bruxism. 4. Smoking patients. 5. Patients with problems in TMJ. 6. Neuromuscular diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
impression techniques for implant used for maxillary screw retained hybrid prosthesis
conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally. evaluation of accuracy and 3D deviation between the two techniques was done

Locations

Country Name City State
Egypt faculty of Dentistry , Mansoura University Mansoura DK

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy of impression technique deviation measurements digitally immediately after the intervention/procedure
Secondary passivity of final restoration Clinical measurement of prosthesis passivity using single screw test of Sheffield. immediately after the intervention/procedure
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