Clinical trial NCT05983718: A Study of Surgical Guide Assisted Dental Implantation in Bangladesh
Official title: Comparison of Positional Accuracy in Dental Implant Placement Between Conventionally Used Guide Pin and 3D Printed Surgical Guide Developed From CBCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Partially Edentulous Mandible
Dental Implantation
Lead sponsor: Dhaka Dental College and Hospital
Sponsor class: OTHER
Collaborators: name: Bangladesh University of Engineering and Technology
First posted: 2023-08-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study that aims to compare the accuracy between full-guided with guide-pin-assisted free-hand dental implant surgeries. The basis of evaluation in each case is the comparison of the preoperative digital plan with the actual postoperative status.

Detailed description: Dental implant surgery is a treatment that replaces damaged or missing teeth with artificial teeth that are aesthetically and functionally similar to natural teeth. For a successful implant surgery, it is necessary to use digital planning software in conjunction with a cone-beam CT scan and a custom-made 3D-printed surgical guide. In developing countries like Bangladesh, surgical guide-assisted dental implant surgery is absent. Doctors attend implant surgeries relying on their visual assessment from x-ray images or CBCT data. They need to cut the outer soft tissue, expose the bone, and use a guide pin to confirm the direction and location. Then they perform implant surgery following the hole created by the guide pin, similar to free-hand surgery. But the overall procedure is still highly invasive and has low accuracy.

Free-hand implant surgeries are still in practice everywhere. The application of a guide pin has been observed in some places to enhance the situation. A guide pin helps an operator recognize the position and angle of an alveolar bone when forming an implantation hole in the alveolar bone to insert an implant into the alveolar bone. Doctors insert a guide pin to the implant site with minimal incision and then confirm the desired direction and location with a radiographic image. However, we need a proper clinical evaluation to compare fully-guided surgeries to guide-pin-assisted surgeries to understand the accuracy of both processes.

The accuracy of the pre-planned 3D-printed surgical guide is well established. Introducing dental software and guided surgery has already achieved higher acceptance in implant surgery. Several patients from several privileged parts of the world benefit from surgical guides. But the usual design convention includes intraoral scanner data with CBCT. However, intraoral scanners are still unavailable in many dental hospitals. The study is designed to address the precision of dental implant surgeries worldwide, especially where the intraoral scanner is not present. In our research, we will focus on partially edentulous patients. And our design procedure will not be dependent on intra-oral scanner data. As partially edentulous patients are higher in number and CBCT machines readily available in hospitals, this study can open up a way to address the scarcity of intra-oral scanner data to avail a large number of implant patients with an effective guide. The success rate of this study will encourage us not only to prioritize guided surgeries over free-hand practices or guide-pin-assisted surgeries but also to significantly impact the execution of implant surgeries in developing countries.

Eligibility criteria: Inclusion Criteria:

* Patients of age between 18 to 75 and of any gender
* Patient fit for implantation (satisfactory soft and hard tissue conditions and occlusion)
* Partially edentulous patient

Exclusion Criteria:

* Patient with pregnancy
* Patient with uncontrolled diabetes mellitus.
* Patient who needed dentoalveolar or associated soft tissue reconstruction procedure
* Patient taking bisphosphonate or have any history of systemic or local bone disease
* Recent extracted sites
* Patients with a history of smoking, alcoholism
* Patient with a history of head-neck radiation
* Patient with associated periapical pathology or history of parafunctional habit
* Patient needs bone grafting.
* Known HIV, Hepatitis B, or Hepatitis C infection.
* Limited mouth opening, which, in the examiner's opinion, would risk the success of the intervention
* Local infection
* Known allergy to any component of the implant or the implant guide

Primary outcomes:
measure: Angular deviation
timeFrame: 3 months
Secondary outcomes:
measure: Apical deviation
timeFrame: 3 months
measure: Coronal deviation
timeFrame: 3 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Dental College and Hospital
Study officials:
affiliation: Dhaka Dental College Hospital
name: Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
role: PRINCIPAL_INVESTIGATOR
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