NCT06947057

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

25 days

First QC Date

April 20, 2025

Last Update Submit

April 20, 2025

Conditions

Keywords

Guided implant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Unilateral tooth supported

ACTIVE COMPARATOR

Unilateral guided implant placement

Procedure: Guided implant placement

Bilateral tooth supported

ACTIVE COMPARATOR

Bilateral guided implant placement

Procedure: Guided implant placement

Full arch mucosa supported

ACTIVE COMPARATOR

Full arch implant placement mucosa supported

Procedure: Guided implant placement

Stackable bone supported

ACTIVE COMPARATOR

Stackable guide, foundation guide and on top implant placement guide

Procedure: Guided implant placement

Interventions

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 supportedFull arch mucosa supportedStackable bone supportedUnilateral tooth supported

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 27, 2025

Study Start

April 20, 2025

Primary Completion

May 15, 2025

Study Completion

May 18, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04