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.
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
- Are there results?
- Not yet: the study is under way
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
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 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.
- 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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07845890
- Acronym / sponsor ID
- S2S-IG RCT / R.26.08.134
- Conditions
- Tooth Loss, Maxillary Premolar Area, Immediate Dental Implant Placement, Guided Implant Placement, Sleeved Static Surgical Guides, Sleeveless Surgical Guide
- Keywords
- Immediate implant placement, Static surgical guide, Sleeved surgical guide, Sleeveless surgical guide, Implant placement accuracy, Premolar region, Digital implant planning
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare implant placement accuracy using sleeved versus sleeveless static surgical guides for immediate implant placement in the premolar region.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 (Sleeved Guide) | Experimental | Procedure: Conventional Sleeved Static Surgical Guide40 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. |
| Study Group 2 (Sleeveless Guide) | Experimental | Procedure: Sleeveless Static Surgical Guide40 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Sleeved Static Surgical GuideImmediate 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. | Procedure or surgery | Study Group 1 (Sleeved Guide) |
| Sleeveless Static Surgical GuideImmediate 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. | Procedure or surgery | Study Group 2 (Sleeveless Guide) |
Primary outcome
Global Coronal Deviation
Time frame: Immediately after implant placement.
The deviation between the planned and actual implant positions at the coronal point will be assessed using CBCT superimposition, measured in mm.
Global Apical Deviation
Time frame: Immediately after implant placement.
The deviation between the planned and actual implant positions at the apical point will be assessed using CBCT superimposition, measured in mm.
Angular Deviation
Time frame: Immediately after implant placement.
The angular deviation between the planned and actual implant axes will be assessed using CBCT superimposition, measured in degrees (°).
Vertical (Depth) Deviation
Time frame: Immediately after implant placement.
The deviation in implant depth between the planned and actual implant positions will be assessed using CBCT superimposition, measured in mm.
5 secondary outcomes
Surgical Time
Time frame: During the surgical procedure.
Prosthetic fit of the prefabricated 3D-printed restoration
Time frame: Immediately after provisional crown placement.
Ease of Guide Use (Operator Assessment)
Time frame: Immediately after implant placement.
Conversion to Freehand Surgery
Time frame: During implant placement.
Intraoperative Patient Comfort
Time frame: Immediately after implant placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Coronal Deviation (time frame: Immediately after implant placement.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.