Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT05983718
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.
Study:
NCT05983718
Study Brief:
Protocol Section:
NCT05983718