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Fully Guided Dental Implant Placement and Primary Stability

U

University of Mosul

Status

Completed

Conditions

Dental Implant Failure
Peri Implantitis
Dental Implant
Cone Beam Computed Tomography

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07149987
self-funded (Other Identifier)
UOM.Dent/25/1029

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria for the study were:

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

The exclusion criteria for the study were: Patients were excluded from the study for the following reasons:

  1. General contraindications to implant surgery;
  2. Patients with history of chemo or radiotherapy;
  3. Poor oral hygiene;
  4. Pregnant or lactating women;
  5. Uncontrolled diabetic patients.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Test Group (Guided Surgery Group)
Experimental group
Description:
Test Group (Guided Surgery Group): Implants were placed using 3D-printed surgical guides
Treatment:
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 group
Description:
Implants were placed freehand without guide assistance

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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