Accuracy of Immediate Implant Placement

NCT07863700 | Recruiting

• 1 other identifier: ADMNF-1326
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical study will compare the accuracy of immediate implant placement performed using three different surgical approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, and a tooth- and socket-supported static surgical guide. Patients requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement will be enrolled. All participants will undergo three-dimensional preoperative treatment planning using cone-beam computed tomography and intraoral scanning. Participants will then be randomly allocated to one of three groups according to the assigned surgical technique. The primary outcome will be the three-dimensional accuracy of implant placement, determined by comparing the virtually planned implant position with the clinically achieved implant position. Coronal, apical, angular, and depth deviations will be evaluated using postoperative three-dimensional imaging. The study will determine whether the use of conventional tooth-supported or tooth- and socket-supported static surgical guides results in different implant positioning accuracy compared with freehand immediate implant placement.

Conditions

Edentulism in Lower Jaw

Keywords

Immediate implant placement; implant placement accuracy; computer-guided implant surgery; implant positional accuracy; mandibular molar

Outcome Measures

Primary Outcomes (1)

• Three-dimensional implant placement accuracy

  Three-dimensional implant placement accuracy will be assessed by comparing the clinically achieved implant position with the preoperatively planned virtual implant position using postoperative cone-beam computed tomography (CBCT) and three-dimensional registration. Accuracy will be evaluated by measuring coronal deviation, apical deviation, angular deviation, and depth deviation between the planned and clinically achieved implant positions.

  Immediately after implant placement

Study Arms (3)

Freehand Immediate Implant Placement

EXPERIMENTAL

Participants assigned to this arm will undergo immediate implant placement using a freehand surgical approach without a surgical guide. The virtually planned implant position will be available as a reference, but no surgical guide will be used during osteotomy preparation or implant insertion.

Procedure: Freehand Immediate Implant Placement

Tooth-Supported Static Surgical Guide

EXPERIMENTAL

Participants assigned to this arm will undergo immediate implant placement using a conventional tooth-supported static surgical guide fabricated according to the finalized virtual implant plan. The guide will be seated and its stability verified before guided osteotomy preparation and implant placement.

Procedure: Tooth-Supported Static Computer-Guided Implant Placement

Tooth- and Socket-Supported Static Surgical Guide

EXPERIMENTAL

Participants assigned to this arm will undergo immediate implant placement using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket. Proper seating and stability will be confirmed before guided osteotomy preparation and implant placement.

Procedure: Tooth- and Socket-Supported Static Guided Implant Placement

Interventions

Tooth-Supported Static Computer-Guided Implant Placement PROCEDURE

Immediate implant placement performed using a conventional tooth-supported static surgical guide fabricated according to the virtual implant plan.

Tooth-Supported Static Surgical Guide

Tooth- and Socket-Supported Static Guided Implant Placement PROCEDURE

Immediate implant placement performed using a tooth- and socket-supported static surgical guide designed to obtain stabilization from both the remaining dentition and the extraction socket.

Tooth- and Socket-Supported Static Surgical Guide

Freehand Immediate Implant Placement PROCEDURE

Immediate implant placement performed using a freehand surgical approach without a surgical guide.

Freehand Immediate Implant Placement

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 20-56 years.
• Patients requiring extraction of a mandibular first or second molar, or a retained root in the same region, followed by immediate implant placement.
• American Society of Anesthesiologists (ASA) Physical Status I or II.
• Satisfactory oral hygiene.
• Ability to comply with the scheduled follow-up protocol.
• Extraction socket classified as a Class I defect.
• Treatment site planned for rehabilitation with a single-unit screw-retained implant-supported crown.
• Adequate primary implant stability, defined as an insertion torque of ≥35 Ncm and/or an implant stability quotient (ISQ) of ≥60.

You may not qualify if:

• Uncontrolled systemic disease.
• Previous radiotherapy to the head and neck region.
• Active untreated periodontal disease.
• Heavy smoking of more than 10 cigarettes per day.
• Bisphosphonate therapy.
• Severe parafunctional habits such as bruxism.
• Inability to achieve adequate primary stability, defined as an insertion torque \<35 Ncm and an ISQ \<60.
• Intraoperative detection of loss of the buccal cortical plate.
• Extraction socket defect exceeding Class I.
• Inability to complete the required follow-up protocol.

Sponsors & Collaborators

• Menoufia University: lead
• Mansoura University: collaborator

Study Sites (1)

Faculty of Dentistry, Menoufia University

Shibīn al Kawm, Menoufia, 2266166, Egypt

RECRUITING

Central Study Contacts

Mohammed A. El-Sawy, PhD

CONTACT

00201061314522; mohamed.elsawy@dent.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor responsible for postoperative three-dimensional registration and measurement of deviations between the planned and clinically achieved implant positions will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Participants will be randomly allocated in a parallel-group design to one of three immediate implant placement approaches: freehand surgery, conventional tooth-supported static computer-guided surgery, or tooth- and socket-supported static surgical guide surgery. Each participant will receive the assigned intervention only.

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 7, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)