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

Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement: A Randomized Clinical Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Single Tooth Lost; Partially Edentulous Maxilla
• Intervention / Treatment: Procedure: guided trephination-based drilling protocol; Procedure: guided Conventional drilling-based 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 Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed Ramadan, bachelor; Phone Number: 01003274889; Email: dentistmh93@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Ainshams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: guided trephination-based 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.	Procedure: guided trephination-based drilling protocol; 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
Active Comparator: 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.	Procedure: guided Conventional drilling-based protocol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mohammed Ramadan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 23, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: dental implant; guided implant; surgical guide; dental trephination; guided trephination
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss; Mouth, Edentulous
• Other Study ID Numbers: FDASU-RecIM012225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: the data that will be shared is the CBCT, virtual planning

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No