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

NCT05295082 | Completed

• 1 other identifier: FDASU-RecIM012225
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Single Tooth Lost; Partially Edentulous Maxilla

Keywords

guided implant; surgical guide; dental implant; dental trephination; guided trephination

Outcome Measures

Primary Outcomes (3)

• Horizontal deviation at apex of the implant.

  measure the Horizontal deviation at apex of the implant between the virtual planning position and the actual implant position

  immediately after the intervention

• •Horizontal deviation at implant shoulder.

  measure the Horizontal deviation at the implant shoulder between the virtual planning position and the actual implant position

  immediately after the intervention

• Angular deviation.

  measure the Angular deviation of the implant between the virtual planning position and the actual implant position

  immediately after the intervention

Secondary Outcomes (2)

• The duration of the surgery

  during the surgery

• Satisfaction assessed by the Visual Analogue Scale

  immediately after the intervention

Study Arms (2)

guided trephination-based protocol

EXPERIMENTAL

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.

Procedure: guided trephination-based drilling protocol

guided conventional drilling-based protocol

ACTIVE COMPARATOR

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.

Procedure: guided Conventional drilling-based protocol

Interventions

guided trephination-based drilling protocol PROCEDURE

the implant site preparation in this group will be done by guided trephination protocol which uses the surgical guide to trephine the implant site then remove the guide and continue the drilling in a freehand manner

guided trephination-based protocol

guided Conventional drilling-based protocol PROCEDURE

the implant site preparation in this group will be done by a guided conventional drilling protocol which uses the surgical guide to guide the sequential drills up to the final drill

guided conventional drilling-based protocol

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mohammed Ramadan: lead

Study Sites (1)

AinShams University

Cairo, Egypt

Location

Related Publications (3)

• Suriyan N, Sarinnaphakorn L, Deeb GR, Bencharit S. Trephination-based, guided surgical implant placement: A clinical study. J Prosthet Dent. 2019 Mar;121(3):411-416. doi: 10.1016/j.prosdent.2018.06.004. Epub 2018 Nov 30.

  PMID: 30503150 RESULT

• Van Assche N, Vercruyssen M, Coucke W, Teughels W, Jacobs R, Quirynen M. Accuracy of computer-aided implant placement. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:112-23. doi: 10.1111/j.1600-0501.2012.02552.x.

  PMID: 23062136 RESULT

• Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Accuracy of a computer-aided implant surgical technique. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):317-25. doi: 10.11607/prd.1019.

  PMID: 23593625 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcome assessor is not involved in the study. he doesn't know the type of intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: guided dental implant placement through guided trephine-based implant site preparation

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 24, 2022
• Study Start: April 1, 2022
• Primary Completion: June 20, 2023
• Study Completion: April 30, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)