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

NCT ID: NCT05295082

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Single Tooth Lost Partially Edentulous Maxilla

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

guided dental implant placement through guided trephine-based implant site preparation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the outcome assessor is not involved in the study. he doesn't know the type of intervention.

Study Groups

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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.

Group Type EXPERIMENTAL

guided trephination-based drilling protocol

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

guided Conventional drilling-based protocol

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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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Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mohammed Ramadan

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Ramadan

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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AinShams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 30503150 (View on PubMed)

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.

Reference Type RESULT
PMID: 23062136 (View on PubMed)

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.

Reference Type RESULT
PMID: 23593625 (View on PubMed)

Other Identifiers

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FDASU-RecIM012225

Identifier Type: -

Identifier Source: org_study_id

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