Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement

Not Applicable

Completed

• Conditions: Partially Edentulous Maxilla; Single Tooth Lost
• Interventions: Procedure: guided trephination-based drilling protocol; Procedure: guided Conventional drilling-based protocol

• Registration Number: NCT05295082
• Lead Sponsor: Mohammed Ramadan

Brief Summary

This study will be initiated to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.

Detailed Description

This study will be conducted to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.

the patients with a single missing tooth will be assigned to one group ( trephination drilling / conventional drilling ).the preoperative virtual planning and fabrication of a surgical guide will be made for each patient. after implant placement according to each group, postoperative (CBCT ) will be performed to compare the virtual implant position and the actual implant position.

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2022-04-01
• Primary Completion: 2023-06-20
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Single missing maxillary premolar or molar tooth.
2. Both genders aged from 20-50 years.
3. Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire. (Pendleton et al,.2004)
4. Mesio-distal space ≥ 7 mm.
5. Bone width in bucco-lingual direction ≥ 6 mm.
6. Uniform alveolar ridge with no undercuts.
7. Present mesial and distal sound neighboring teeth.
8. At least 4 natural remaining teeth on the same arch.
9. Mouth opening at least 30 mm.

Exclusion Criteria

1. Pregnant and lactating females. 2) Smokers. 3) Poor oral hygiene. 4) Vulnerable groups of patients' e.g. (handicapped patients).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
guided trephination-based protocol	guided trephination-based drilling protocol	The drilling process will be performed by guided trephination protocol. * An appropriate trephine drill (Helmut Zepf Medizintechnik GmbH, Germany) will be used to create an initial osteotomy. * The guide will be removed, and the depth and angulation of this initial osteotomy will be evaluated. * The final drill of the chosen implant system will be used to complete the osteotomy. * The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner.
guided conventional drilling-based protocol	guided Conventional drilling-based protocol	The drilling process will be performed by a guided conventional drilling protocol. * Drilling (Neo NaviGuide System - Neobiotech Co. Ltd. Korea) will be performed throughout the guiding sleeve from the first drill to the final drill. * The guide will be removed. * The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner.

Primary Outcome Measures

Name	Time	Method
Angular deviation.	immediately after the intervention	measure the Angular deviation of the implant between the virtual planning position and the actual implant position
Horizontal deviation at apex of the implant.	immediately after the intervention	measure the Horizontal deviation at apex of the implant between the virtual planning position and the actual implant position
•Horizontal deviation at implant shoulder.	immediately after the intervention	measure the Horizontal deviation at the implant shoulder between the virtual planning position and the actual implant position

Secondary Outcome Measures

Name	Time	Method
Satisfaction assessed by the Visual Analogue Scale	immediately after the intervention	measure the patient satisfaction score on terms of pain and discomfort from 1 to 10
The duration of the surgery	during the surgery	measure the time of the surgery from the first drill to the implant placement

Trial Locations

Locations (1)

AinShams University; 🇪🇬 Cairo, Egypt