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A Study of Surgical Guide Assisted Dental Implantation in Bangladesh

NCT05983718 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-09-26

No results posted yet for this study

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.

Conditions

  • Partially Edentulous Mandible
  • Dental Implantation

Interventions

DEVICE

Surgical Guide

For this case, after the patient is given anesthesia, the guide will be placed on the teeth. All the drillings will be performed through the guided path. There will be no need for raising flap according to flapless surgery. At the end of the operation, the operation site will be checked and hemostasis will be provided. The operator will record the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.

PROCEDURE

Guide-pin-assisted Freehand surgery

The regular protocol of the implant surgery will be followed. Before the surgery begins, the patient will be given anesthesia to ensure they are comfortable and pain-free during the procedure. Doctors will go through the digital planning to understand the desired angulation. Then the bony bed will be prepared raising flap from targeted area. Then a guide-pin will be inserted by drilling and through radiographic image the direction will be confirmed. Following the hole of the guide-pin, the implant will be inserted. At the end of the operation, the raised flap will be sewn and hemostasis will be provided. The operator records the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.

Sponsors & Collaborators

  • Bangladesh University of Engineering and Technology

    collaborator OTHER

  • Dhaka Dental College and Hospital

    lead OTHER

Principal Investigators

  • Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics) · Dhaka Dental College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2024-04-30
Completion
2024-07-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983718 on ClinicalTrials.gov