Clinical trial NCT06723678: Evaluation of Bone Changes Around Implants in Patients Treated With All on Four
Official title: Radiographic Evaluation of Crestal Bone Changes Around Implants in Patients Treated With Delayed Loaded All on Four (Randomized Clinical Trail)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge In Mandible
Complete Edentulism
All on Four Technique
Dental Implant
Edentulous Jaws
Edentulous Mouth
Keywords: Completely edentulous patients
Dental Implants
All on four technique
Fixed Detachable Prosthesis
screw retained prosthesis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Goal of the clinical trail is to evaluate the Bone height changes around two axially placed anterior implants and two distally inclined 30-degree angle posterior implants in comparison to two axially placed anterior implants and two distally inclined 45-degree angle posterior implants using cone beam CT (CBCT).

Patients will visit the clinic after the surgery and after the framework and denture insertion for check ups and during the follow up periods ( at denture insertion, 6 months and 12 months)

Detailed description: All patients will receive upper complete dentures and mandibular All on-4 screw-retained prosthesis. The upper complete denture will be mucosa supported and the lower will be All on-4 screw-retained prosthesis. Patients will be divided into two equal groups; Group I will receive two axially placed anterior implants and two distally inclined 30-degree angle posterior implants, while Group II will receive two axially placed anterior implants and two distally inclined 45-degree angle posterior implants.

Both groups will be functionally loaded after three months of insertion. Bone height changes around axial and distally inclined implants will be evaluated using cone beam CT (CBCT), All records will be taken at time of denture insertion, 6 and 12 months later.

Eligibility criteria: Inclusion Criteria:

* All patients' ages must range from 50-65 years old.
* All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
* Patients should be free from any metabolic or bone disorders that contraindicate implant installation.
* All patients must have sufficient inter arch space

Exclusion Criteria:

* Patients with oral or systemic diseases.
* Patients with xerostomia or excessive salivation.
* Patients with parafunctional habits (bruxism or clenching).
* Heavy smoker or alcoholic patients.
* Patients with history of temporo-mandibular dysfunction.
* Patients with brain disorders or psychiatric disorders

Primary outcomes:
measure: Bone Height Changes
timeFrame: All records will be taken at time of denture insertion, 6 and 12 months later.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University Girls Branch
state: Nasr City
Study officials:
References: