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

Study Overview
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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.

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

Conditions
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Single Tooth Lost, Partially Edentulous Maxilla

Intervention / Treatment
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* Procedure: guided trephination-based drilling protocol
* Procedure: guided Conventional drilling-based protocol


Participation Criteria
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Eligibility Criteria
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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). -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: guided trephination-based protocol<br>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<br>* 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<br>|
| Active Comparator: guided conventional drilling-based protocol<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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guided implant, surgical guide, dental implant, dental trephination, guided trephination