Classifying Fully Guided Surgical Guides

Classifying Fully Guided Surgical Guides: A Comprehensive Analysis of Accuracy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Prostheses
• Intervention / Treatment: Procedure: Guided implant placement

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unilateral tooth supported; Unilateral guided implant placement	Procedure: 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)
Active Comparator: Bilateral tooth supported; Bilateral guided implant placement	Procedure: 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)
Active Comparator: Full arch mucosa supported; Full arch implant placement mucosa supported	Procedure: 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)
Active Comparator: Stackable bone supported; Stackable guide, foundation guide and on top implant placement guide	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angular deviation	The angle closed by the principal axis of the planned implant and the principal axis of the inserted implant in degrees	Immediately postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2025
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): May 18, 2025

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Guided implant
• Other Study ID Numbers: 111333

Drug and device information, study documents

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