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/36424579/Actively Recruiting
Led by Universidad Complutense de Madrid · Updated on 2025-03-26
48
Participants Needed
1
Research Sites
N/A
Total Duration
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
Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides
I
Ignacio Sanz-Sánchez, DDS, MSc, PHD
J
Juan Ernesto Del Rosal, DDS
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Universidad Complutense de Madrid
Lead Sponsor
Klockner Implant System
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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)
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
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)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/32654230/Universidad Complutense de Madrid
Lead Sponsor
Klockner Implant System
Collaborating Sponsor