Fully Guided Dental Implant Placement and Primary Stability

NCT07149987 | Completed DMC

• 2 other identifiers: UOM.Dent/25/1029self-funded
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Dental Implant Failure; Peri Implantitis; Cone Beam Computed Tomography

Keywords

3D- implant surgical guide; C-Tech® implants; DICOM file

Outcome Measures

Primary Outcomes (2)

• post operative pain

  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

  From placement of implant immediately and to the 2nd visit of treatment at one week

• primary stability improvement

  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

  For all the patient in the study primary stability was assessed immediately after implant placement

Secondary Outcomes (1)

• secondary stability outcome measure

  For all the patient in the study, the secondary stability was assessed three months from implant placement

Study Arms (2)

Test Group (Guided Surgery Group)

EXPERIMENTAL

Test Group (Guided Surgery Group): Implants were placed using 3D-printed surgical guides

Procedure: All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area

Control Group (Freehand Surgery Group)

NO INTERVENTION

Implants were placed freehand without guide assistance

Interventions

All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area PROCEDURE

All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area. The implants used in this study were C-Tech® implants (C-Tech Implant, Italy) with the following dimensions: Diameter: 3.8 mm Length: 11 mm . Cone-Beam Computed Tomography (CBCT): To assess bone quality, quantity, and anatomical structures . Digital Intraoral Scans Heron Scanner (USA) to obtain detailed gingival contours, occlusion, and existing teeth. The scan data was exported as an STL file for digital planning. Easy Check Implant Stability Measuring System is used for implant stability measurement, the tapping rod was gently placed in slight contact with the healing abutment, avoiding any axial or lateral pressure, and aligned within 0°-30° relative to the abutment's occlusal surface. If the angle exceeded 30°, the device issued an alert and prevented measurement, ensuring consistent alignment

Test Group (Guided Surgery Group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age.
• Presenting with maxillary tooth loss,
• Tooth extraction at least 3 months before (delayed placement)
• Adequate amount of bone volume to place the implant without bone augmentation (2 mm bone circumferentially around the implant).

You may not qualify if:

• General contraindications to implant surgery;
• Patients with history of chemo or radiotherapy;
• Poor oral hygiene;
• Pregnant or lactating women;
• Uncontrolled diabetic patients.

Sponsors & Collaborators

• University of Mosul: lead

Study Sites (1)

University of Mosul/ College of Dentistry/ oral and Maxillofacial depart./Teaching dental Clinics unit/dental implant and laser unit

Mosul, +964, Iraq

Location

Related Publications (36)

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Related Links

• The official website of C-Tech Implant (www.c-tech-implant.com) provides comprehensive and up-to-date information on the company's range of dental implant systems and accessories.

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• AbdAlhameed N. Aldabagh, AssistProfDr

  Department of OMFS, College of Dentistry, University of Mosul, Nineveh, Iraq

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof.Dr. Munib Abdullah Fathi

Model Details: 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 Record Dates

• First Submitted: July 16, 2025
• First Posted: September 2, 2025
• Study Start: January 10, 2025
• Primary Completion: May 15, 2025
• Study Completion: June 20, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)