Clinical trial NCT06376019: Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants
Official title: Evaluation of Occlusion and Disocclusion Time in Immediately Loaded Implant Supported Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Edentulous Jaw
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment of the participants in ratio 1:1:1 will take place. For allocation concealment, opaque sealed envelopes will be used.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of occlusion/disocclusion time
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Ahmed MA Mohamed, BDS MSc MD
role: PRINCIPAL_INVESTIGATOR
References: