Clinical trial NCT06571968: Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible
Official title: Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible by Using Fully Versus Semi Guided Prototyped Surgical Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Placement
Keywords: Fully-guided surgical stent
semi-guided surgical stent
accuracy analysis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 36
Sex: ALL
Minimum age (years): 58
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: DIAGNOSTIC

Brief summary: Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants.

Detailed description: Objectives: Current study aimed to assess the accuracy of fully- guided implant placement in completely lower edentulous patients compared to the semi-guided protocol.

Materials and Methods: Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants. Measurements and analysis of results were performed by means of a software tool used during virtual planning (P3Dental; Protótipos).

Eligibility criteria: inclusion criteria:

* All patient wearing maxillary conventional denture.
* All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
* They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
* All patients are of angel's class I maxillo-mandibular relationships.

Exclusion Criteria:

* Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
* Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
* Long term immunosuppress and corticosteroid drug therapy.
* Patient with abnormal habits as clenching and bruxism.
* Smoking patient.
* Patient with problems in TMJ

Primary outcomes:
measure: Radio graphic evaluation (Angular deviation)
timeFrame: one year
Secondary outcomes:
measure: Radio graphic evaluation (linear deviation)
timeFrame: one year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Marwa Aboelez
Study officials:
affiliation: Mansoura University
name: marwa aboelez, Phd
role: STUDY_CHAIR
affiliation: Mansoura University
name: Hassan Kheriba, Msd
role: STUDY_DIRECTOR
References:
citation: Malpartida-Carrillo V, Tinedo-Lopez PL, Ortiz-Culca F, Guerrero ME, Amaya-Pajares SP. Techniques for retrievability and for registering screw access holes in cement-retained implant-supported prostheses: A scoping review of the literature. J Prosthet Dent. 2020 Mar;123(3):427-433. doi: 10.1016/j.prosdent.2019.03.011. Epub 2019 Jul 12.