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NCT06376019 Clinical Trial

Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants

Edentulous Jaw Clinical Trial

Official title:
Evaluation of Occlusion and Disocclusion Time in Immediately Loaded Implant Supported Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06376019
Other study ID # FDASU-RecID11352
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 25, 2024
Est. completion date September 15, 2024

Study information
Verified date April 2024
Source Ain Shams University
Contact Ahmed MA Mohamed, BDS MSc,MD
Phone 01111191337
Email ahmedmostafa@dent.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

Description:

The gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. However, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. Implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. The immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. Pierluigi Mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. The technique of intraoral welding provides rigid splinting in cases of immediate implant loading. Occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. Quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 27
Est. completion date September 15, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: - completely edentulous patients - non-smokers - good oral hygiene - motivated patients Exclusion Criteria: - major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus - the need for extensive bone grafting in planned implant site - pregnancy - patients under bisphosphonate treatment - limited mouth-opening for executing the implant surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• solitary Implant loading with ball attachment
ball attachment will be attached to the dental implant on the day of implant placement
• splinted Implant loading with intra oral welding
Titanium bar will be welded to the dental implant on the day of implant placement
• complete denture
Mucosa supported conventional complete denture will be fabricated without supporting implants

Locations
Country Name City State
Egypt Faculty of Dentistry Ain Shams University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of occlusion/disocclusion time occlusion/disocclusion time will be evaluated using a T scan device 3 months
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