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A Study of Surgical Guide Assisted Dental Implantation in Bangladesh

Primary Purpose

Partially Edentulous Mandible, Dental Implantation

Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Surgical Guide
Guide-pin-assisted Freehand surgery
Sponsored by
Dhaka Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partially Edentulous Mandible

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dhaka Dental College and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FREE HAND (GUIDE-PIN-assisted)

FULL GUIDED

Arm Description

Outcomes

Primary Outcome Measures

Angular deviation
The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.

Secondary Outcome Measures

Apical deviation
The deviation of the implant's apical point from the anticipated apical position in three dimensions, measured in millimeters.
Coronal deviation
The deviation of the implant's coronal point from the anticipated coronal position in three dimensions, measured in millimeters.

Full Information

First Posted
August 2, 2023
Last Updated
September 25, 2023
Sponsor
Dhaka Dental College and Hospital
Collaborators
Bangladesh University of Engineering and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05983718
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dhaka Dental College and Hospital
Collaborators
Bangladesh University of Engineering and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Mandible, Dental Implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FREE HAND (GUIDE-PIN-assisted)
Arm Type
Active Comparator
Arm Title
FULL GUIDED
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Surgical Guide
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Guide-pin-assisted Freehand surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Angular deviation
Description
The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Apical deviation
Description
The deviation of the implant's apical point from the anticipated apical position in three dimensions, measured in millimeters.
Time Frame
3 months
Title
Coronal deviation
Description
The deviation of the implant's coronal point from the anticipated coronal position in three dimensions, measured in millimeters.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
Phone
+8801715748863
Email
dr.sarkar.bds@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Muhammad Tarik Arafat, B.Sc., Ph.D.
Phone
+8801911764467
Email
tarikarafat@bme.buet.ac.bd
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
Organizational Affiliation
Dhaka Dental College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhaka Dental College and Hospital
City
Dhaka
ZIP/Postal Code
1206
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Md. Al-Amin Sarkar
Phone
+8801715748863
Email
dr.sarkar.bds@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Mst. Jannatul Ferdous
Phone
+88029038266
Email
ddch@hospi.dghs.gov.bd
First Name & Middle Initial & Last Name & Degree
Dr. Md. Al-Amin Sarkar, BDS, FCPS (Prosthodontics)
First Name & Middle Initial & Last Name & Degree
Dr. Muhammad Tarik Arafat, B.Sc., Ph.D.
First Name & Middle Initial & Last Name & Degree
Dr. Taufiq Hasan Al Banna, B.Sc., M.Sc., Ph.D.
First Name & Middle Initial & Last Name & Degree
Dr. Jahid Ferdous, B.Sc., M.Sc., Ph.D.
First Name & Middle Initial & Last Name & Degree
Dr. Mst. Jannatul Ferdous, BDS, MS (Prosthodontics)
First Name & Middle Initial & Last Name & Degree
Dr. Ashik Abdullah, BDS, MS (OMS)
First Name & Middle Initial & Last Name & Degree
Dr. Tasrif Ahmed, BDS, MS (OMS)

12. IPD Sharing Statement

Plan to Share IPD
No
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A Study of Surgical Guide Assisted Dental Implantation in Bangladesh

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