Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion
Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT06080815
Collaborator
(none)
30
1
2
9.9
3
Study Details
Study Description
Brief Summary
This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups.
Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method.
Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups.
Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method.
Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Mandibular 4-Implant Overdenture Base Construction Techniques on Assessment of Occlusion With Digital Occlusion Analysis System (Within Patient Study)
Actual Study Start Date
:
May 10, 2022
Actual Primary Completion Date
:
Dec 15, 2022
Actual Study Completion Date
:
Mar 7, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture
|
Device: CAD/CAM Complete denture
four implant-supported CAD/CAM complete overdenture
|
| Active Comparator: Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture
|
Device: CAD/CAM Complete denture
four implant-supported CAD/CAM complete overdenture
|
Outcome Measures
Primary Outcome Measures
- digital occlusal analysis [6 months]
occlusion was analyzed by occlusense device
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
- Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture
Exclusion Criteria:
- diabetic and heavy smoker patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura University | Mansoura | Egypt | 35516 |
Sponsors and Collaborators
- Mansoura University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT06080815
Other Study ID Numbers:
- 05201021
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: