Digital versus radiographic accuracy evaluation of guided implant surgery: an in vitro study.
Chun Yi, Sha Li, Aonan Wen...
https://pubmed.ncbi.nlm.nih.gov/36424579Actively Recruiting
Phase Not Applicable
Age: 21Years +
All Genders
ID06819995
Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides, a Randomized Clinical Trial
Led by Universidad Complutense de Madrid · Updated on 2025-03-26
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universidad Complutense de Madrid
Lead Sponsor
K
Klockner Implant System
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy and long-term outcomes of dental implants placed using two types of static surgical guides: 3D-printed and milled. The study focuses on patients needing dental implant rehabilitation and aims to determine if there are differences in implant placement precision and clinical success between these guide fabrication methods. This randomized controlled trial also considers peri-implant health, implant survival, and patient satisfaction as important factors. Participants will be randomly assigned to receive implant surgery guided by either a 3D-printed or a milled surgical guide. Both guides are designed with sleeves to ensure precise implant placement based on digital planning. The surgery is performed under local anesthesia, with follow-ups scheduled for suture removal and healing checks. After three months, digital impressions will be taken to assess implant position accuracy and to fabricate final prostheses, which will be placed about one month later. Follow-up visits at six and twelve months post-prosthesis placement will monitor implant stability and overall success. During the study, participants undergo thorough dental examinations including radiographs, photographs, and intraoral scans. Researchers will measure implant position accuracy by comparing planned and final implant locations and assess outcomes such as probing depth, bleeding, implant survival, and patient-reported pain and satisfaction. Medication use and healing progress will be recorded, and all implant treatments and monitoring are closely supervised for one year. The study includes careful data protection and offers implant-related components at no cost, with some participant costs for surgery and prosthetic parts.
CONDITIONS
Brief Title
Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides
Who Can Participate
Age: 21Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients with one to four missing teeth planned for dental implants with tooth-supported or tooth-mucosal supported surgical guides
- Edentulous sites healed for at least 3 months after tooth extraction
- Patients with staged hard and soft tissue augmentation respecting minimum healing periods (6 months for bone, 2 months for soft tissue)
- Implants must be surrounded by at least 1.5 mm of bone
- Periodontally healthy or stable patients after periodontal therapy
- Aged 21 years and older and able to sign informed consent
- Sufficient bone available for Klockner Vega implants with diameters 3.5-4.5 mm and lengths 8-12 mm
You will not qualify if you...
- Completely edentulous patients or those needing mucosal- or bone-supported surgical guides
- Patients with compromised general health (ASA IV-VI)
- Systemic diseases influencing therapy outcome (e.g., uncontrolled diabetes, bone disorders)
- Pregnant or nursing women
- Chronic use of corticosteroids, NSAIDs, or immune-modulator drugs
- Use of medications affecting bone metabolism (e.g., bisphosphonates)
- Chronic oral mucosa diseases
- Smokers of more than 10 cigarettes per day
- More than 25% plaque index after periodontal therapy and hygiene instructions
- Unable to attend all study visits
- Need for simultaneous bone augmentation after implant placement with less than 1.5 mm bone around implant
- Lack of primary stability after implant placement
- Less than 2 mm keratinized mucosa at implant sites
- Surgical guides that do not fit properly or cannot be adjusted
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Pre-study phase and guide fabrication
Duration - Varies depending on participant compliance and planning
Participants receive oral hygiene instructions and periodontal therapy if needed, followed by intraoral and CBCT scans for digital planning. Surgical guides are then fabricated by either 3D printing or milling according to randomization.
1 to 2 visits for scans and planning
Treatment
Duration - Single day procedure with postoperative care lasting 2 weeks
Participants undergo static guided implant placement using either a 3D-printed or milled surgical guide under local anesthesia. Surgical procedures include implant bed preparation, implant insertion, and placement of healing abutments.
1 surgical visit (in-person) and approximately 1 visit at 7 days for suture removal
Postoperative follow-up
Duration - Up to 1 month
Participants follow postoperative care instructions including medication and oral hygiene guidance. Sutures are removed after 7 days. Follow-up includes monitoring healing and oral hygiene reinforcement.
Approximately 2 visits (7 days and 1 month post-surgery)
Prosthetic restoration and loading
Duration - At 3 months post-surgery
Digital impressions are taken 3 months after surgery for fabrication of definitive restorations. Functional loading of the implant is performed, marking the baseline for subsequent follow-up.
1 visit for digital impression and restoration placement
Follow-up monitoring
Duration - 9 months (from 3 to 12 months post-surgery)
Participants are monitored for implant success, peri-implant health, and patient-reported outcomes through follow-up visits at 6 and 12 months after loading.
2 visits (6 and 12 months post-loading)
Trial Site Locations
Total: 1 location
1
Facultad de Odontología, Universidad Complutense de Madrid
Madrid, Spain, 28040
Actively Recruiting
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Research Team
I
Ignacio Sanz-Sánchez, DDS, MSc, PHD
J
Juan Ernesto Del Rosal, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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Faris Younes, Jan Cosyn, Thomas De Bruyckere...
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Tianhong Tang, Luman Liao, Zhuoli Huang...
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Ramadhan Hardani Putra, Nobuhiro Yoda, Eha Renwi Astuti...
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Lucio Lo Russo, Laura Guida, Pierluigi Mariani...
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Fausto Frizzera, Nicolas Nicchio Nicolini Calazans, Cristiano Hooper Pascoal...
https://pubmed.ncbi.nlm.nih.gov/34411217Accuracy of static computer-assisted implant placement in anterior and posterior sites by clinicians new to implant dentistry: in vitro comparison of fully guided, pilot-guided, and freehand protocols.
Jaafar Abduo, Douglas Lau
https://pubmed.ncbi.nlm.nih.gov/32157478Clinical and tomographic comparison of dental implants placed by guided virtual surgery versus conventional technique: A split-mouth randomized clinical trial.
Gabriel L Magrin, Stela N F Rafael, Bernardo B Passoni...
https://pubmed.ncbi.nlm.nih.gov/31628873Static computer-aided, partially guided, and free-handed implant placement: A systematic review and meta-analysis of randomized controlled trials.
Mustafa Tattan, Leandro Chambrone, Oscar González-Martín...
https://pubmed.ncbi.nlm.nih.gov/32654230