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

Primary Purpose

Single Tooth Lost, Partially Edentulous Maxilla

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

guided trephination-based drilling protocol

guided Conventional drilling-based protocol

About this trial

This is an interventional other trial for Single Tooth Lost focused on measuring guided implant, surgical guide, dental implant, dental trephination, guided trephination

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

AinShams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

guided trephination-based protocol

guided conventional drilling-based protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

•Horizontal deviation at implant shoulder.

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

Angular deviation.

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

Secondary Outcome Measures

The duration of the surgery

measure the time of the surgery from the first drill to the implant placement

Satisfaction assessed by the Visual Analogue Scale

measure the patient satisfaction score on terms of pain and discomfort from 1 to 10

Full Information

NCT ID

NCT05295082

First Posted

March 3, 2022

Last Updated

July 23, 2022

Sponsor

Mohammed Ramadan

1. Study Identification

Unique Protocol Identification Number

NCT05295082

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2022 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mohammed Ramadan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Single Tooth Lost, Partially Edentulous Maxilla

Keywords

guided implant, surgical guide, dental implant, dental trephination, guided trephination

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

guided trephination-based protocol

Arm Type

Experimental

Arm Description

Arm Title

guided conventional drilling-based protocol

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

guided trephination-based drilling protocol

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

guided Conventional drilling-based protocol

Intervention Description

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

Primary Outcome Measure Information:

Title

Horizontal deviation at apex of the implant.

Description

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

Time Frame

immediately after the intervention

Title

•Horizontal deviation at implant shoulder.

Description

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

Time Frame

immediately after the intervention

Title

Angular deviation.

Description

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

Time Frame

immediately after the intervention

Secondary Outcome Measure Information:

Title

The duration of the surgery

Description

measure the time of the surgery from the first drill to the implant placement

Time Frame

during the surgery

Title

Satisfaction assessed by the Visual Analogue Scale

Description

measure the patient satisfaction score on terms of pain and discomfort from 1 to 10

Time Frame

immediately after the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed Ramadan, bachelor

Phone

01003274889

dentistmh93@gmail.com

Facility Information:

Facility Name

AinShams University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

the data that will be shared is the CBCT, virtual planning

Citations:

PubMed Identifier

30503150

Citation

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.

Results Reference

result

PubMed Identifier

23062136

Citation

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.

Results Reference

result

PubMed Identifier

23593625

Citation

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.

Results Reference

result

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

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