3D Evaluation of Free-handed-Countersink Guided and Fully Guided Implant Surgery in Partially Edentulous Patients

NCT07061418 | Completed DMC

• 1 other identifier: PHRC/HC/1242/23
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial with a quasi-experimental design investigates the accuracy of dental implant placement using three different surgical approaches: free-handed countersink guided, fully-guided, and traditional freehand techniques in partially edentulous patients. Dental implant therapy not only requires successful osseointegration but also a precise three-dimensional placement to ensure functional and esthetic outcomes. Accurate implant positioning is vital to prevent complications and ensure long-term stability. The evolution of digital technology has led to the development of computer-assisted implant surgery, enhancing surgical precision and minimizing the chances of deviation from planned positions. In this study, implants were placed in the same patients on both sides of the jaw using two techniques for comparison - one side received a free-handed countersink guided implant, while the other used a fully-guided surgical guide. Patients included in this research were partially dentate adults with adequate oral health, bone volume, and no systemic conditions or habits that could interfere with healing. Pre-operative and post-operative cone-beam computed tomography (CBCT) scans were used to evaluate the positional accuracy of the implants. The three-dimensional evaluation method utilized Blue Sky Plan 4 and 3D Slicer software to superimpose and analyze implant placements. Parameters such as angular deviation, crestal global deviation, apical global deviation, vertical linear deviation, lateral linear deviation, apical vertical deviation, apical lateral deviation, and distances from anatomical structures like the inferior alveolar nerve and the maxillary sinus were measured to assess placement accuracy. Measurements were taken using automatic image registration and STL superimposition of planned versus actual implant locations. Data collected was analyzed using SPSS software. Both descriptive and inferential statistical analyses were conducted. The results aimed to determine the accuracy differences between countersink-guided and fully-guided implant techniques. The findings of this study contribute to evidence-based clinical decisions in implant dentistry by exploring if countersink-guided approaches offer comparable accuracy to fully-guided methods, thus supporting safer and more effective dental implant procedures in clinical practice.

Conditions

Partially Edentulous Jaw; Accuracy of Dental Implant Placement; Implant Deviation and Positioning Errors; Proximity to Anatomical Structures

Keywords

Countersink guided; Quasi experimental study; fully guided; Accuracy; Partially edentulous

Outcome Measures

Primary Outcomes (1)

• Angular deviation

  The primary outcome was angular deviation defined as the angle closed by the principal axis of the planned implant and the principal axis of the inserted implant in degrees.

  3 months

Secondary Outcomes (8)

• Crestal global deviation

  3 months

• Apical global deviation

  3 months

• Coronal Center Deviation

  3 months

• Apical Endpoint Deviation and Vertical Deviation

  3 months

• Hexagonal Lateral Deviation

  3 months

Study Arms (2)

Freehand immediate implant placement

EXPERIMENTAL

Other: Dental Implant

Surgery guide implant placement

ACTIVE COMPARATOR

Other: Dental Implant

Interventions

Dental Implant OTHER

Dental implants were placed to volunteers in need of implantation in mandible, maxilla or both

Freehand immediate implant placement; Surgery guide implant placement

Eligibility Criteria

• Age: 18 Years - 53 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Partially dentate adults with at least 6 remaining teeth
• The anticipated presence of sufficient bone volume allowing for implant placement with no simultaneous bone grafting
• Extractions within 2 months of welding.
• Want the missing tooth to be replaced by an implant
• Adequate related attached mucosa was found
• Mouth opening ≥ 40 mm
• Good oral hygiene
• Good general health

You may not qualify if:

• Heavy smoking
• Physical or psychiatric disorders preventing the implant treatment.
• Previous radiotherapy of the head-neck region
• Younger than 18 years

Sponsors & Collaborators

• Islamic University of Caza, Gaza, Palestine: lead

Study Sites (1)

Al-Azhar University

Gaza, Gaza Strip, 00970, Palestinian Territories

Location

Related Publications (4)

• Bell CK, Sahl EF, Kim YJ, Rice DD. Accuracy of Implants Placed with Surgical Guides: Thermoplastic Versus 3D Printed. Int J Periodontics Restorative Dent. 2018 Jan/Feb;38(1):113-119. doi: 10.11607/prd.3254.

  PMID: 29240212 RESULT

• De Angelis F, Papi P, Mencio F, Rosella D, Di Carlo S, Pompa G. Implant survival and success rates in patients with risk factors: results from a long-term retrospective study with a 10 to 18 years follow-up. Eur Rev Med Pharmacol Sci. 2017 Feb;21(3):433-437.

  PMID: 28239830 RESULT

• Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11.

  PMID: 25503901 RESULT

• Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.

  PMID: 29608793 RESULT

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

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: Dr.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: February 23, 2023
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)