A Study of Surgical Guide Assisted Dental Implantation in Bangladesh

September 25, 2023 updated by: Dr. Md. Al-Amin Sarkar, Dhaka Dental College and Hospital

Comparison of Positional Accuracy in Dental Implant Placement Between Conventionally Used Guide Pin and 3D Printed Surgical Guide Developed From CBCT

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
  • Phone Number: +8801715748863
  • Email: dr.sarkar.bds@gmail.com

Study Contact Backup

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1206
        • Recruiting
        • Dhaka Dental College and Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Md. Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
        • Sub-Investigator:
          • Dr. Muhammad Tarik Arafat, B.Sc., Ph.D.
        • Sub-Investigator:
          • Dr. Taufiq Hasan Al Banna, B.Sc., M.Sc., Ph.D.
        • Sub-Investigator:
          • Dr. Jahid Ferdous, B.Sc., M.Sc., Ph.D.
        • Sub-Investigator:
          • Dr. Mst. Jannatul Ferdous, BDS, MS (Prosthodontics)
        • Sub-Investigator:
          • Dr. Ashik Abdullah, BDS, MS (OMS)
        • Sub-Investigator:
          • Dr. Tasrif Ahmed, BDS, MS (OMS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FREE HAND (GUIDE-PIN-assisted)
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.
Experimental: FULL GUIDED
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angular deviation
Time Frame: 3 months
The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apical deviation
Time Frame: 3 months
The deviation of the implant's apical point from the anticipated apical position in three dimensions, measured in millimeters.
3 months
Coronal deviation
Time Frame: 3 months
The deviation of the implant's coronal point from the anticipated coronal position in three dimensions, measured in millimeters.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dhaka Dental College and Hospital

Collaborators

Bangladesh University of Engineering and Technology

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BME-BUET-DDCH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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