AzTrials
AzTrials

Dental ImplantNCT07149987

Fully Guided Dental Implant Placement and Primary Stability

A study of Dental Implant and Dental Implant Failure, run by University of Mosul at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIraq
Study dates
10 Jan 2025to 20 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

Iraq1 site

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

    Mosul, +964

Other trials in Iraq

About this study

Official title: Assessing the Role of 3D-Printed Surgical Guides in Enhancing Dental Implant Placement Precision and Patient Outcomes

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.

Read the 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.

Being tested
All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area
Keywords
3D- implant surgical guide, C-Tech® implants, DICOM file
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical areaProcedure or surgery

    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

Study groups in NCT07149987
Study groupRoleWhat they receive
Test Group (Guided Surgery Group)ExperimentalTest Group (Guided Surgery Group): Implants were placed using 3D-printed surgical guides
Receives: 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 interventionImplants were placed freehand without guide assistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (1)

  1. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start10 Jan 2025
  3. Primary completion15 May 2025
  4. Study completion20 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07149987
Sponsor's protocol ID
UOM.Dent/25/1029
Other IDs
self-funded
Status last verified
Nov 2025
First submitted
16 Jul 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 24021974

  • Barone A, Toti P, Piattelli A, Iezzi G, Derchi G, Covani U. Extraction socket healing in humans after ridge preservation techniques: comparison between flapless and flapped procedures in a randomized clinical trial. J Periodontol. 2014 Jan;85(1):14-23. doi: 10.1902/jop.2013.120711. Epub 2013 May 20.

    PubMed 23688103

  • Hultin M, Svensson KG, Trulsson M. Clinical advantages of computer-guided implant placement: a systematic review. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:124-35. doi: 10.1111/j.1600-0501.2012.02545.x.

    PubMed 23062137

  • Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.

    PubMed 20497439

  • Cassetta M, Bellardini M. How much does experience in guided implant surgery play a role in accuracy? A randomized controlled pilot study. Int J Oral Maxillofac Surg. 2017 Jul;46(7):922-930. doi: 10.1016/j.ijom.2017.03.010. Epub 2017 Mar 31.

    PubMed 28366450

  • Huang YC, Huang YC, Ding SJ. Primary stability of implant placement and loading related to dental implant materials and designs: A literature review. J Dent Sci. 2023 Oct;18(4):1467-1476. doi: 10.1016/j.jds.2023.06.010. Epub 2023 Jun 25.

    PubMed 37799926

  • Kim J, Park JY, Lee JY, Kim DM, Lee J, Jung UW, Lim YJ, Cha JK. Randomized controlled trial on the efficacy of a custom-made, fully guided implant system for flapless crestal sinus floor elevation: Accuracy and patient-reported outcomes. Clin Oral Implants Res. 2024 Dec;35(12):1531-1545. doi: 10.1111/clr.14341. Epub 2024 Aug 5.

    PubMed 39101395

  • Nagar P, Husain Z, Gupta U, Sheth M, Mishra R, Muthuraj HL. Comparative Study of Implant Placement Techniques and Their Effect on Long-Term Success of Implant-Supported Restorations. J Pharm Bioallied Sci. 2024 Dec;16(Suppl 4):S3500-S3502. doi: 10.4103/jpbs.jpbs_973_24. Epub 2024 Nov 13.

    PubMed 39926875

  • Rungcharassaeng K, Caruso JM, Kan JY, Schutyser F, Boumans T. Accuracy of computer-guided surgery: A comparison of operator experience. J Prosthet Dent. 2015 Sep;114(3):407-13. doi: 10.1016/j.prosdent.2015.04.004. Epub 2015 Jun 25.

    PubMed 26119019

  • Malo P, de Araujo Nobre M, Lopes A. The use of computer-guided flapless implant surgery and four implants placed in immediate function to support a fixed denture: preliminary results after a mean follow-up period of thirteen months. J Prosthet Dent. 2007 Jun;97(6 Suppl):S26-34. doi: 10.1016/S0022-3913(07)60005-5.

    PubMed 17618930

  • Di Giacomo GA, da Silva JV, da Silva AM, Paschoal GH, Cury PR, Szarf G. Accuracy and complications of computer-designed selective laser sintering surgical guides for flapless dental implant placement and immediate definitive prosthesis installation. J Periodontol. 2012 Apr;83(4):410-9. doi: 10.1902/jop.2011.110115. Epub 2011 Aug 5.

    PubMed 21819249

  • Moraschini V, Velloso G, Luz D, Barboza EP. Implant survival rates, marginal bone level changes, and complications in full-mouth rehabilitation with flapless computer-guided surgery: a systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2015 Jul;44(7):892-901. doi: 10.1016/j.ijom.2015.02.013. Epub 2015 Mar 17.

    PubMed 25790741

  • Ramakrishna R, Nayar S. Clinical assessment of primary stability of endosseous implants placed in the incisor region, using resonance frequency analysis methodology: an in vivo study. Indian J Dent Res. 2007 Oct-Dec;18(4):168-72. doi: 10.4103/0970-9290.35826.

    PubMed 17938492

  • Sul YT, Johansson CB, Jeong Y, Wennerberg A, Albrektsson T. Resonance frequency and removal torque analysis of implants with turned and anodized surface oxides. Clin Oral Implants Res. 2002 Jun;13(3):252-9. doi: 10.1034/j.1600-0501.2002.130304.x.

    PubMed 12010155

  • Javed F, Ahmed HB, Crespi R, Romanos GE. Role of primary stability for successful osseointegration of dental implants: Factors of influence and evaluation. Interv Med Appl Sci. 2013 Dec;5(4):162-7. doi: 10.1556/IMAS.5.2013.4.3. Epub 2013 Dec 20.

    PubMed 24381734

Questions about this trial

What is this clinical trial studying?

A study of Dental Implant and Dental Implant Failure, run by University of Mosul at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post operative pain (time frame: From placement of implant immediately and to the 2nd visit of treatment at one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07149987, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in