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| ID | Type | Description | Link |
|---|---|---|---|
| self-funded | Other Identifier | UOM-Oral and Maxillofacial surgery Department |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group (Guided Surgery Group) | Experimental | Test Group (Guided Surgery Group): Implants were placed using 3D-printed surgical guides |
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| Control Group (Freehand Surgery Group) | No Intervention | Implants were placed freehand without guide assistance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| secondary stability outcome measure | 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 | For all the patient in the study, the secondary stability was assessed three months from implant placement |
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The inclusion criteria for the study were:
The exclusion criteria for the study were: Patients were excluded from the study for the following reasons:
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| Name | Affiliation | Role |
|---|---|---|
| AbdAlhameed N. Aldabagh, AssistProfDr | Department of OMFS, College of Dentistry, University of Mosul, Nineveh, Iraq | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mosul/ College of Dentistry/ oral and Maxillofacial depart./Teaching dental Clinics unit/dental implant and laser unit | Mosul | +964 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24021974 | Background | Marra R, Acocella A, Rispoli A, Sacco R, Ganz SD, Blasi A. Full-mouth rehabilitation with immediate loading of implants inserted with computer-guided flap-less surgery: a 3-year multicenter clinical evaluation with oral health impact profile. Implant Dent. 2013 Oct;22(5):444-52. doi: 10.1097/ID.0b013e31829f1f7f. | |
| 23688103 | Background |
| Label | URL |
|---|---|
| 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. | View source |
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Individual Participant Data (IPD) will not be shared for this study due to ethical considerations and confidentiality regulations. The study protocol does not include plans for IPD sharing, in accordance with institutional and national data protection policies
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2025 | Aug 16, 2025 |
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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
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| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2025 | Aug 16, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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