Classifying Fully Guided Surgical Guides

NCT ID: NCT06947057

Last Updated: 2025-04-27

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-20

Study Completion Date

2025-05-18

Brief Summary

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Surgical guides can be classified according to support into tooth-supported, mucosa-supported, bone-supported, or a combination of these. Tooth-supported templates are further divided into unilateral or bilateral tooth support. Bilateral tooth-supported guides refer to templates that are supported by templates on both sides while unilateral tooth support refers to templates that is supported by teeth on one side and mucosa or bone from the other side. Usually, mucosa-supported guides are utilized in full arch cases in which there is no need for bone reduction. Stackable guides are the best option when bone reduction is indicated because they allow for the planning of both implant osteotomies and bone sculpturing using a single template made up of different components. This study compare all static guided protocols( bilateral tooth supported, unilateral tooth supported, full arch mucosa supported, stackable bone supported ) with each other under homogenous conditions.

Detailed Description

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Surgical guides can be classified according to support into tooth-supported, mucosa-supported, bone-supported, or a combination of these. Tooth-supported templates are further divided into unilateral or bilateral tooth support. Bilateral tooth-supported guides refer to templates that are supported by templates on both sides while unilateral tooth support refers to templates that is supported by teeth on one side and mucosa or bone from the other side. Usually, mucosa-supported guides are utilized in full arch cases in which there is no need for bone reduction. Stackable guides are the best option when bone reduction is indicated because they allow for the planning of both implant osteotomies and bone sculpturing using a single template made up of different components.

Theoretically, bilateral tooth-supported guides offer the most accuracy since they offer the best retention and biomechanical stability with anchorage on hard tissues. According to a recent systematic review, unilateral tooth guides exhibited higher deviations except in global coronal deviation where unilateral tooth-supported guides exhibited slightly lower distribution than bilateral guides, and in in vivo global apical deviation where bilateral and unilateral tooth-supported guides showed a similar data range.

Despite the increasing predictability of guided surgery, there will always be differences between the virtual plan and actual performance. The accuracy of static computer-aided implant operations was assessed in the 2018 International Team for Implantology consensus document. According to the study, the variations for the mean crestal point, apical point, angle, coronal depth, and apical depth were 1.2 mm, 1.4 mm, 3.5 o, 0.2 mm, and 0.5 mm, respectively. A safety margin of 2 mm ought to be taken into account at all times, based on the previously indicated precision.

For the purposes of this study, accuracy is defined as the closeness of spatial agreement between any given implant as planned (reference) and as inserted (measurement), expressed by four spatial deviation parameters

Conditions

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Dental Prostheses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Unilateral tooth supported

Unilateral guided implant placement

Group Type ACTIVE_COMPARATOR

Guided implant placement

Intervention Type PROCEDURE

The four types of fully guided surgical guides (bilateral tooth-supported guides, unilateral tooth-supported guides, mucosa-supported full arch guides and stackable guides)

Bilateral tooth supported

Bilateral guided implant placement

Group Type ACTIVE_COMPARATOR

Guided implant placement

Intervention Type PROCEDURE

The four types of fully guided surgical guides (bilateral tooth-supported guides, unilateral tooth-supported guides, mucosa-supported full arch guides and stackable guides)

Full arch mucosa supported

Full arch implant placement mucosa supported

Group Type ACTIVE_COMPARATOR

Guided implant placement

Intervention Type PROCEDURE

The four types of fully guided surgical guides (bilateral tooth-supported guides, unilateral tooth-supported guides, mucosa-supported full arch guides and stackable guides)

Stackable bone supported

Stackable guide, foundation guide and on top implant placement guide

Group Type ACTIVE_COMPARATOR

Guided implant placement

Intervention Type PROCEDURE

The four types of fully guided surgical guides (bilateral tooth-supported guides, unilateral tooth-supported guides, mucosa-supported full arch guides and stackable guides)

Interventions

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Guided implant placement

The four types of fully guided surgical guides (bilateral tooth-supported guides, unilateral tooth-supported guides, mucosa-supported full arch guides and stackable guides)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Missing either only one tooth or partially or fully edentulous.
* Good oral hygiene.
* Systemic free.

Exclusion Criteria

* Conditions that might render intraoral manipulation impossible (limited mouth opening, excessive gag reflex).
* Bisphosphonate treatment (either at the time of screening or in the history).
* Radiotherapy, irradiation of the mandible or the maxilla (either at the time of screening or in the history).
* Smokers.
* Untreated periodontal disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Adel Salah Khattab

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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111333

Identifier Type: -

Identifier Source: org_study_id

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