Fully Guided Dental Implant Placement and Primary Stability

Not Applicable

Completed

• Conditions: Dental Implant; Dental Implant Failure; Peri Implantitis; Cone Beam Computed Tomography

• Registration Number: NCT07149987
• Lead Sponsor: University of Mosul

Brief Summary

The precision of dental implant placement is vital for long-term implant success. The surgical guide is designed using advanced 3D imaging techniques allows for a highly accurate simulation of the ideal implant position, angulation, and depth based on the patient's unique anatomy. The aim of the study is to compare implant stability and postoperative pain between guided and freehand surgical implant placement. The research objective is to assess and compare the clinical outcomes of guided surgical implants placement versus conventional freehand implant placement, focusing on primary implant stability, secondary implant stability and postoperative pain. In alignment with this objective, the aim of this study is to compare the clinical outcomes: as implant primary and secondary stability and postoperative pain between guided surgical implant placement and conventional freehand surgical implant placement.

Hypothesis of the study This study hypothesized that guided implant surgery will result in superior implant stability outcome and reduced postoperative pain compared to the freehand technique High light of study. The use of advance technology (machines and software programs) to enhance implant survival and reduce surgical complications associated with implant placement. It is worth noting that, a fully guided implant placement provides flapless surgery and the implant positions were virtually planned based on anatomical and prosthetic considerations. The use of Easy Check Implant Stability Measuring System for measuring primary and secondary implant stability.

Detailed Description

Background: The precision of dental implant placement is vital for long-term implant success. The surgical guide is designed using advanced 3D imaging techniques allows for a highly accurate simulation of the ideal implant position, angulation, and depth based on the patient's unique anatomy. The aim of the study is to compare implant stability and postoperative pain between guided and freehand surgical implant placement.

Methods: randomized controlled clinical study included 30 patients with a total of 30 implants were placed and analyzed. All patients were randomly allocated into two groups: Test Group (Guided Surgery Group) and Control Group (Freehand Surgery Group). For all the patient in the study primary stability was assessed immediately after implant placement and secondary stability was assessed three months postoperatively. Postoperative pain was measured using the (VAS), immediately after surgery and one week later.

Study Timeline

• Study Start: 2025-01-10
• Primary Completion: 2025-05-15
• Study Completion: 2025-06-20
• Study First Submitted: 2025-07-16
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-24
• Last Update Submitted: 2025-08-24
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
post operative pain	From placement of implant immediately and to the 2nd visit of treatment at one week	Postoperative pain was measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), immediately after surgery and one week later
primary stability improvement	For all the patient in the study primary stability was assessed immediately after implant placement	For all the patient in the study primary stability was assessed postoperatively using ISQ. The Scale Implant Stability Quotient (ISQ) range between 1 to 100. The Interpretation of scores as follow: ISQ \>70: High stability ISQ 60-69: Moderate stability ISQ \<60: Low stability

Secondary Outcome Measures

Name	Time	Method
secondary stability outcome measure	For all the patient in the study, the secondary stability was assessed three months from implant placement	the secondary stability was assessed using ISQ. The Scale Implant Stability Quotient (ISQ) range between 1 to 100. The Interpretation of scores as follow: ISQ \>70: High stability ISQ 60-69: Moderate stability ISQ \<60: Low stability

Trial Locations

Locations (1)

University of Mosul/ College of Dentistry/ oral and Maxillofacial depart./Teaching dental Clinics unit/dental implant and laser unit; 🇮🇶 Mosul, Iraq