A Study of Surgical Guide Assisted Dental Implantation in Bangladesh

NCT05983718 | Unknown DMC

• 1 other identifier: BME-BUET-DDCH-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Partially Edentulous Mandible; Dental Implantation

Outcome Measures

Primary Outcomes (1)

• Angular deviation

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

  3 months

Secondary Outcomes (2)

• Apical deviation

  3 months

• Coronal deviation

  3 months

Study Arms (2)

FREE HAND (GUIDE-PIN-assisted)

ACTIVE COMPARATOR

Procedure: Guide-pin-assisted Freehand surgery

FULL GUIDED

EXPERIMENTAL

Device: Surgical Guide

Interventions

Surgical Guide DEVICE

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.

FULL GUIDED

Guide-pin-assisted Freehand surgery PROCEDURE

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.

FREE HAND (GUIDE-PIN-assisted)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dhaka Dental College and Hospital: lead
• Bangladesh University of Engineering and Technology: collaborator

Study Sites (1)

Dhaka Dental College and Hospital

Dhaka, 1206, Bangladesh

RECRUITING

Related Publications (16)

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Study Officials

• Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)

  Dhaka Dental College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics)

CONTACT

+8801715748863; dr.sarkar.bds@gmail.com

Dr. Muhammad Tarik Arafat, B.Sc., Ph.D.

CONTACT

+8801911764467; tarikarafat@bme.buet.ac.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Consultant

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: August 23, 2023
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)