Clinical trial NCT06947057: Classifying Fully Guided Surgical Guides
Official title: Classifying Fully Guided Surgical Guides: A Comprehensive Analysis of Accuracy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Prostheses
Keywords: Guided implant
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Angular deviation
timeFrame: Immediately postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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