Sleeved vs. Sleeveless Guides for Immediate Implant Placement

NCT07845890 | Active Not Recruiting DMC

• 1 other identifier: R.26.08.134
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Loss; Immediate Dental Implant Placement; Sleeved Static Surgical Guides; Sleeveless Surgical Guide; Bone Grafting; Provisional Crown; Maxillary Premolar Area; Guided Implant Placement; Customized Healing Abutment

Keywords

Immediate implant placement; Static surgical guide; Sleeved surgical guide; Sleeveless surgical guide; Implant placement accuracy; Premolar region; Digital implant planning

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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 (°).

  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.

  Immediately after implant placement.

Secondary Outcomes (5)

• Surgical Time

  During the surgical procedure.

• Prosthetic fit of the prefabricated 3D-printed restoration

  Immediately after provisional crown placement.

• Ease of Guide Use (Operator Assessment)

  Immediately after implant placement.

• Conversion to Freehand Surgery

  During implant placement.

• Intraoperative Patient Comfort

  Immediately after implant placement.

Study Arms (2)

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.

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.

Procedure: Sleeveless Static Surgical Guide

Interventions

Conventional Sleeved Static Surgical Guide PROCEDURE

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.

Study Group 1 (Sleeved Guide)

Sleeveless Static Surgical Guide PROCEDURE

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 2 (Sleeveless Guide)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 29, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)