Fully Guided Dental Implant Placement and Primary Stability
NCT ID: NCT07149987
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2025-01-10
2025-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.
NCT07174791
A Study of Surgical Guide Assisted Dental Implantation in Bangladesh
NCT05983718
Peri-implant Soft Tissue and Bone Evaluation in Fully Computer Guided Immediate Implants
NCT06733870
DLP Versus SLM Stackable Surgical Guide
NCT05617443
Classifying Fully Guided Surgical Guides
NCT06947057
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test Group (Guided Surgery Group)
Test Group (Guided Surgery Group): Implants were placed using 3D-printed surgical guides
All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area
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
Control Group (Freehand Surgery Group)
Implants were placed freehand without guide assistance
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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).
Exclusion Criteria
2. Patients with history of chemo or radiotherapy;
3. Poor oral hygiene;
4. Pregnant or lactating women;
5. Uncontrolled diabetic patients.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Mosul
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Munib Abdullah Fathi
Assist.Prof.Dr. Munib Abdullah Fathi
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AbdAlhameed N. Aldabagh, AssistProfDr
Role: PRINCIPAL_INVESTIGATOR
Department of OMFS, College of Dentistry, University of Mosul, Nineveh, Iraq
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Mosul/ College of Dentistry/ oral and Maxillofacial depart./Teaching dental Clinics unit/dental implant and laser unit
Mosul, , Iraq
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wahlberg RD, Stenport VF, Wennerberg A, Hjalmarsson L. A Multicenter Study of Factors Related to Early Implant Failures-Part 1: Implant Materials and Surgical Techniques. Clin Implant Dent Relat Res. 2025 Feb;27(1):e70015. doi: 10.1111/cid.70015.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Bahrami R, Pourhajibagher M, Nikparto N, Bahador A. Robot-assisted dental implant surgery procedure: A literature review. J Dent Sci. 2024 Jul;19(3):1359-1368. doi: 10.1016/j.jds.2024.03.011. Epub 2024 Mar 19.
20. Agha RA, Mathew G, Rashid R, Kerwan A, Al-Jabir A, Sohrabi C, Franchi T, Nicola M, Agha M, TITAN Group. Transparency In The reporting of Artificial INtelligence - the TITAN guideline. Premier Journal of Science 2025:10;100082
Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.
Chrcanovic BR, Kisch J, Albrektsson T, Wennerberg A. Factors Influencing Early Dental Implant Failures. J Dent Res. 2016 Aug;95(9):995-1002. doi: 10.1177/0022034516646098. Epub 2016 May 4.
Oh SH, Kim Y, Park JY, Jung YJ, Kim SK, Park SY. Comparison of fixed implant-supported prostheses, removable implant-supported prostheses, and complete dentures: patient satisfaction and oral health-related quality of life. Clin Oral Implants Res. 2016 Feb;27(2):e31-7. doi: 10.1111/clr.12514. Epub 2014 Oct 24.
Pjetursson BE, Bragger U, Lang NP, Zwahlen M. Comparison of survival and complication rates of tooth-supported fixed dental prostheses (FDPs) and implant-supported FDPs and single crowns (SCs). Clin Oral Implants Res. 2007 Jun;18 Suppl 3:97-113. doi: 10.1111/j.1600-0501.2007.01439.x.
Asghar AM, Sadaf D, Ahmad MZ, Jackson G, Bonsor SJ. Comparing clinical outcomes of immediate implant placement with early implant placement in healthy adult patients requiring single-tooth replacement in the aesthetic zone: a systematic review and meta-analysis of randomised controlled trials. Evid Based Dent. 2023 Jun;24(2):93. doi: 10.1038/s41432-023-00902-7. Epub 2023 Jun 5.
Kim Y, Oh TJ, Misch CE, Wang HL. Occlusal considerations in implant therapy: clinical guidelines with biomechanical rationale. Clin Oral Implants Res. 2005 Feb;16(1):26-35. doi: 10.1111/j.1600-0501.2004.01067.x.
Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: Updated guideline for reporting randomised trials. PLoS Med. 2025 Apr 14;22(4):e1004587. doi: 10.1371/journal.pmed.1004587. eCollection 2025 Apr.
Chackartchi T, Romanos GE, Parkanyi L, Schwarz F, Sculean A. Reducing errors in guided implant surgery to optimize treatment outcomes. Periodontol 2000. 2022 Feb;88(1):64-72. doi: 10.1111/prd.12411.
Kumar Pandey A, Akkara F, Dhupar V. Efficacy of implant placement with surgical guides in the rehabilitation of the edentulous areas: An observational study and review of literature. Adv Oral Maxillofac Surg. 2022;8:100320
Al Kabany MH. 3D-Printed Implant Sliding Guide: A New Dental Implant Surgical Guide. Int J Oral Maxillofac Implants. 2023 Oct 17;38(5):874-884. doi: 10.11607/jomi.10271.
Yeung M, Abdulmajeed A, Carrico CK, Deeb GR, Bencharit S. Accuracy and precision of 3D-printed implant surgical guides with different implant systems: An in vitro study. J Prosthet Dent. 2020 Jun;123(6):821-828. doi: 10.1016/j.prosdent.2019.05.027. Epub 2019 Oct 23.
Huang L, Liu L, Yang S, Khadka P, Zhang S. Evaluation of the accuracy of implant placement by using implant positional guide versus freehand: a prospective clinical study. Int J Implant Dent. 2023 Dec 1;9(1):45. doi: 10.1186/s40729-023-00512-z.
Corbella S, Morandi B, Calciolari E, Alberti A, Francetti L, Donos N. The influence of implant position and of prosthetic characteristics on the occurrence of peri-implantitis: a retrospective study on periapical radiographs. Clin Oral Investig. 2023 Dec;27(12):7261-7271. doi: 10.1007/s00784-023-05303-9. Epub 2023 Nov 1.
Chen ST, Buser D, Sculean A, Belser UC. Complications and treatment errors in implant positioning in the aesthetic zone: Diagnosis and possible solutions. Periodontol 2000. 2023 Jun;92(1):220-234. doi: 10.1111/prd.12474. Epub 2023 Jan 22.
Greenberg AM. Digital technologies for dental implant treatment planning and guided surgery. Oral Maxillofac Surg Clin North Am. 2015 May;27(2):319-40. doi: 10.1016/j.coms.2015.01.010.
Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
Esposito M, Hirsch JM, Lekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (II). Etiopathogenesis. Eur J Oral Sci. 1998 Jun;106(3):721-64. doi: 10.1046/j.0909-8836..t01-6-.x.
Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UOM.Dent/25/1029
Identifier Type: -
Identifier Source: org_study_id
self-funded
Identifier Type: OTHER
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.