Tooth LossS2S-IG RCTNCT07845890

Sleeved vs. Sleeveless Guides for Immediate Implant Placement

A study testing Conventional Sleeved Static Surgical Guide and Sleeveless Static Surgical Guide in people with Tooth Loss and Maxillary Premolar Area, run by Mansoura University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study aims to compare implant placement accuracy using sleeved versus sleeveless static surgical guides for immediate implant placement in the premolar region. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Tooth Loss, Maxillary Premolar Area, Immediate Dental Implant Placement
What is being tested?: Conventional Sleeved Static Surgical Guide and Sleeveless Static Surgical Guide
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2026to 15 Nov 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patients with non-restorable teeth in premolar area requiring dental extraction.
Age range: from18 to 50 years.
Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration.
Jumping gap more than 2mm.
Patients with good oral hygiene.
Patients willing to participate in the study's follow-up intervals.

Who cannot join

Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
Alcohol or drug abuse.
Smokers.
Patients with systemic diseases that absolutely contraindicate implant placement (bleeding disorders, immunosuppression,…etc.)
Pregnancy.
Patients with para-functional habits (bruxism and clenching).
Lack of motivation or inability to maintain good oral hygiene.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry Mansoura University
Al Mansurah, Dakahlia Governorate

Other trials in Egypt

About this study

Official title: Implant Placement Accuracy and Clinical Outcomes of Sleeved Versus Sleeveless Static Surgical Guides for Immediate Implant Placement in the Premolar Region: A Randomized Controlled Clinical Trial

This study aims to compare implant placement accuracy using sleeved versus sleeveless static surgical guides for immediate implant placement in the premolar region.

Read the detailed description

This randomized controlled clinical trial will evaluate the accuracy of immediate implant placement using sleeved versus sleeveless static surgical guides in the premolar region.

A total of 80 immediate implants will be placed, with 40 implants allocated to each group.

The surgical protocol, implant system and dimensions, drilling protocol, and postoperative care will be standardized.

Implant placement accuracy will be assessed by comparing the planned and actual implant positions.

Coronal, apical, and angular deviations, as well as overall implant placement accuracy, will be evaluated between the two groups.

Conditions: Tooth Loss, Maxillary Premolar Area, Immediate Dental Implant Placement, Guided Implant Placement, Sleeved Static Surgical Guides, Sleeveless Surgical Guide
Being tested: Conventional Sleeved Static Surgical Guide, Sleeveless Static Surgical Guide
Keywords: Immediate implant placement, Static surgical guide, Sleeved surgical guide, Sleeveless surgical guide, Implant placement accuracy, Premolar region, Digital implant planning
Medical subject headings: Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conventional Sleeved Static Surgical GuideProcedure or surgery
Immediate implant placement in the maxillary premolar region using a conventional sleeved static surgical guide, with silicate-added β-tricalcium phosphate grafting of the peri-implant gap and placement of a provisional crown.
Sleeveless Static Surgical GuideProcedure or surgery
Immediate implant placement in the maxillary premolar region using a sleeveless static surgical guide, with silicate-added β-tricalcium phosphate grafting of the peri-implant gap and placement of a provisional crown.

Study groups in NCT07845890
Study group	Role	What they receive
Study Group 1 (Sleeved Guide)	Experimental	40 immediate dental implants will be placed using a conventional sleeved static surgical guide in the maxillary premolar region. Silicate-added β-tricalcium phosphate graft will be used to fill the peri-implant gap, followed by placement of a provisional crown. Receives: Procedure: Conventional Sleeved Static Surgical Guide
Study Group 2 (Sleeveless Guide)	Experimental	40 immediate dental implants will be placed using a sleeveless static surgical guide in the maxillary premolar region. Silicate-added β-tricalcium phosphate graft will be used to fill the peri-implant gap, followed by placement of a provisional crown. Receives: Procedure: Sleeveless Static Surgical Guide

What is being measured

The primary outcome is the main question the study is designed to answer.

Global Coronal Deviation
The deviation between the planned and actual implant positions at the coronal point will be assessed using CBCT superimposition, measured in mm.
Measured: Immediately after implant placement.
Global Apical Deviation
The deviation between the planned and actual implant positions at the apical point will be assessed using CBCT superimposition, measured in mm.
Measured: Immediately after implant placement.
Angular Deviation
The angular deviation between the planned and actual implant axes will be assessed using CBCT superimposition, measured in degrees (°).
Measured: Immediately after implant placement.
Vertical (Depth) Deviation
The deviation in implant depth between the planned and actual implant positions will be assessed using CBCT superimposition, measured in mm.
Measured: Immediately after implant placement.

Secondary outcomes (5)

Surgical Time
Surgical time will be recorded in minutes from complete seating and verification of the surgical guide until completion of implant insertion. It will be compared between the sleeved and sleeveless guide groups to assess surgical efficiency.
Measured: During the surgical procedure.
Prosthetic fit of the prefabricated 3D-printed restoration
The operating surgeon will assess prosthetic fit:
Score 0: Passive fit without any adjustment. Score 1: Occlusal adjustment only. Score 2: Occlusal and minor axial adjustment required. Score 3: Major adjustment required or restoration could not be delivered as planned.
Measured: Immediately after provisional crown placement.
Ease of Guide Use (Operator Assessment)
The operating surgeon will rate guide use on a 5-point Likert scale (1 = very difficult; 5 = very easy), considering seating, drill accessibility, visibility, and handling.
Measured: Immediately after implant placement.
Conversion to Freehand Surgery
Conversion from guided to freehand implant placement will be recorded as Yes/No, with the reason for conversion documented.
Measured: During implant placement.
Intraoperative Patient Comfort
Patient comfort will be assessed using a 10-cm VAS (0 = extremely uncomfortable; 10 = extremely comfortable).
Measured: Immediately after implant placement.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202615 Nov 2026

First posted29 Sep 2026
Study start1 Jan 2026
Primary completion15 Oct 2026 (estimated)
Study completion15 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tooth LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07845890
Sponsor's protocol ID: R.26.08.134
Acronym: S2S-IG RCT
Status last verified: Sep 2026
First submitted: 20 Sep 2026
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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