Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides, a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Angular deviation
研究概览
简要总结
Dear Patient,
You are invited to participate in a clinical study. To understand the study, please carefully review the following information. If you have any questions, feel free to ask the dentist leading the study.
Dental implants are an effective, long-term solution for replacing missing teeth. They replace the root of a lost or unsalvageable tooth, supporting a crown or prosthesis to restore function and aesthetics. Proper placement is crucial for implants to function and last. Guided implant surgery is a technique that improves precision using customized surgical guides created from patient records, such as radiographs and scans. These guides act as templates to ensure accurate implant placement, optimizing functionality, aesthetics, and minimizing complications.
There are two main methods for fabricating surgical guides: milling, which cuts material into shape, and 3D printing, which builds material layer by layer. This study aims to evaluate the differences in accuracy and long-term outcomes between implants placed using guides created by these two methods. Both clinical results (appearance and function) and radiographic results (bone integration) will be assessed to determine the best method for guide fabrication.
You were selected for this study because you require dental implant rehabilitation. After clinical and radiographic evaluations, we determined you are a suitable candidate for implant placement to restore your dental function and aesthetics.
If you choose to participate, the following steps will be taken:
- A thorough examination of your dental health, including radiographs and photographs.
- Planning and guided surgery performed at the Postgraduate Program in Periodontics.
- Random assignment to receive either a 3D-printed or milled surgical guide. This assignment will be computer-generated and remain unknown until the study concludes.
- Surgery under local anesthesia, lasting 1-2 hours, followed by suture removal after 7 days and follow-ups at 2 and 3 weeks to monitor healing.
- At 3 months, clinical and radiographic evaluations will be performed, and digital impressions will be taken to assess differences between planned and final implant positions. The impressions will also be used to fabricate your final prosthesis, which will be placed approximately one month later.
- Follow-ups at 6 and 12 months after prosthesis placement will assess implant stability and overall outcomes. The study will conclude after this final evaluation.
Participation involves certain risks:
- Anesthesia-related risks, such as allergic reactions, prolonged numbness, or local tissue damage.
- Surgical risks, including pain, swelling, bleeding, infection, temporary or permanent numbness, and damage to adjacent teeth or roots.
- Implant failure, either during initial bone integration or later, requiring additional treatment or replanning.
- Risks of material failure, such as fractures or loosening of prosthetic components.
By participating, you will avoid costs for the implants, healing abutments, and surgical guides (approximate savings: €800-€1,200). However, you will be responsible for surgery (€60), prosthetic components (€250 each), and final restorations (€350 per crown). Participation also includes close monitoring of your implants for one year, allowing for early detection and management of complications at no cost.
Participation is voluntary. If you decide not to participate, it will not affect your care. You may also withdraw from the study at any time without penalty, although clinical follow-ups are recommended to monitor your treatment outcomes.
Your data will be handled anonymously and securely, in compliance with data protection laws (e.g., Spain's Organic Law 3/2018). Data will be used solely for research purposes and not for commercial gain. Identifiable information will not be published, and your rights to access, correct, or delete your data will be upheld.
If you have questions, you may contact the research team by phone or email. You may also consult your dentist or the Ethics Committee. A copy of this document is available for your records.
Thank you for considering participation in this study.
详细描述
- SCIENTIFIC BACKGROUND AND RATIONALE
Traditionally, implant placement has been based on bone availability, with the implant industry focused primarily on enhancing implant survival by increasing the chances of osseointegration. In contrast, the position of the final prosthetic rehabilitation was considered of secondary importance. In certain instances, this approach may result in biological, prosthetic, and aesthetic complications. In contemporary dentistry, evaluating the success of implant therapy transcends the mere evaluation of implant survival and involves a comprehensive assessment that takes into consideration the long-term stability of soft and hard peri-implant tissues, access for oral hygiene, aesthetic demands, occlusal and functional dynamics, implant loading potential, and minimal invasiveness.
Digital-based planning and guided surgery can maximize the chances of placing implants in an ideal prosthetic position. Different types of guided surgery have been described in the literature: (1) Static cast-based partial guidance, which considers the final prosthetic position without considering bone morphology and in which bone bed preparation and implant placement are free-handed. (2) Static computer-based partial guidance, in which the underlying bone morphology is considered in manufacturing the surgical guide, and that can be used for the initial, partial, or complete osteotomy, but implant placement is still free-handed. (3) Static computer-based full guidance that entails the utilization of a pre-made surgical template, involving both complete osteotomy preparation and implant placement guided by a prosthetically driven surgical guide; and (4) Dynamic guidance, that allows real-time guidance during drilling, with the implant position dynamically displayed on computed tomography data. Dynamic guides are associated with higher economic costs and pose challenges in in their clinical implementation, and consequently, static guides are more frequently utilized. The type of support for the guide can be categorized into three groups: mucosal-supported, tooth-supported (may be combined with mucosal-supported), or bone-supported.
Implant surgical guides can be produced through two manufacturing processes: subtractive and additive manufacturing. The subtractive approach involves milling the surgical guide from a larger polymer block through a computer-numeric controlled machine. The additive approach is based on 3D printing the guide by sequential layering. In general, additive processes are more frequently employed, due to reduced expenses, the production of more guides per printing session, and minimal waste.
Recent systematic reviews have demonstrated that static fully guided surgery has higher accuracy to achieve the planned position than free-handed and partially guided implant placement . Indeed, different RCTs have reported higher chances of obtaining a prosthetically correct implant position allowing for screw-retained restorations, lower mean depth deviation, lower angular deviation, as well as three-dimensional body deviations when using static guidance with respect to free-handed implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Each patient will be randomized into the milled or 3D-printed group according to a balanced distribution system via a computer-generated table of random numbers. Allocation concealment will be kept during the surgery by means of opaque envelopes so that the patient is blinded, and it will be kept until the moment of data analysis by an independent researcher not involved in the execution of the clinical interventions. Opaque sealed envelopes will be opened at the milling center once the 3D implant planning has finished, been checked, and sent.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with one to four missing teeth, where dental implants are planned and where a tooth-supported or tooth-mucosal supported surgical guides can be fabricated. Free-ended situations will be allowed.
- •Edentulous sites with at least 3 months of healing after tooth extraction.
- •Staged hard and soft tissue augmentation will be permitted. In cases of previous bone augmentation (e.g. staged horizontal bone regeneration or lateral sinus lift), a minimum healing period of 6 months should be respected. In cases of previous soft tissue augmentation procedures, a minimum healing period of 2 months should be respected. Simultaneous close sinus lift procedures will be allowed when there is a minimum posterior bone height of 6 mm.
- •Implants should be surrounded by at least 1.5 mm of bone.
- •Periodontally healthy patients or with stable periodontal conditions after periodontal therapy. Periodontitis will be defined according to the EFP-AAP 2017 World Workshop Classification (Papapanou PN, Sanz M, et al., 2018): interdental CAL is detectable at ≥2 non-adjacent teeth or buccal or oral CAL ≥3 mm with pocketing ≥3 mm is detectable at ≥2 teeth, but the observed CAL cannot be ascribed to non-periodontitis-related causes such as 1) gingival recession of traumatic origin; 2) dental caries extending in the cervical area of the tooth; 3) the presence of CAL on the distal aspect of a second molar and associated with malposition or extraction of a third molar, 4) an endodontic lesion draining through the marginal periodontium; and 5) the occurrence of a vertical root fracture.
- •Aged 21 years and over and able to sign an informed consent form.
- •Enough available bone assessed on CBCT to place Klockner Vega implants of diameters ranging from 3.5 to 4.5 mm and lengths between 8 and 12 mm.
排除标准
- •Completely edentulous patients or patients requiring mucosal- or bone-supported surgical guides.
- •Compromised general health (ASA IV-VI patients).
- •Systemic diseases which could influence the outcome of therapy (uncontrolled diabetes mellitus, bone disorders, etc.).
- •Pregnant or nursing women.
- •Chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAID), or immune-modulator drugs (any type and dose).
- •Patients who need medications that affect bone metabolism (bisphosphonates, any type and dose).
- •Chronic diseases of the oral mucosa.
- •Smokers of >10 cigarettes/day.
- •>25% plaque index at the time of re-evaluation after non-surgical periodontal therapy and OHI
- •Unable to attend all study visits.
- •Need of simultaneous bone augmentation after implant placement to treat dehiscence and fenestration type defects or to augment bone contour (<1.5 mm of bone all around the implant circumference).
- •During surgery
- •Lack of primary stability assessed by hand testing after implant placement.
- •Less of 2 mm of keratinized mucosa, both at the lingual and buccal sites.
- •Lack of guide adjustment verified through the fitting windows.
研究组 & 干预措施
3-D printed guide
Patients will receive guided dental implants by means of a 3D-printed static surgical guide.
干预措施: Static guided implant placement with a 3D printed guide (Procedure)
Milled guide
Patients will receive guided dental implants by means of a milled static surgical guide.
干预措施: Static guided implant placement with a milled guide (Procedure)
结局指标
主要结局
Angular deviation
时间窗: From planned implant position (presurgical digital plan) to final implant position (taken 3 months after implant placement, when performing the digital impression for the definitive crown)
The discrepancy between the planned and actual placed implants will be measured to determine the accuracy of implant placement by superimposition of the virtual plan for the implant position and the postoperative scan. Angular deviation will be reported in degrees and will be measured from the most coronal point of the implant shoulder to the implant apex. All measurements will be performed by the same researcher, and in cases of more than one implant placed on the same patient the measurements will be performed separately. Measurements will be obtained digitally.
次要结局
- Implant success(6 and 12 month follow up visits)
- Discomfort during surgery(Immediately after surgery)
- Swelling(Immediately after surgery and 1-, 2-, 3-, 4-, 5-, 6-, 7 days post-operatively)
- Duration of surgery(During implant placement)
- Bleeding on Probing (BoP)(From the loading visit, to 6 and 12 month follow-up visits)
- Implant survival(6 and 12 month follow up visits)
- Implant stability(During implant placement)
- Insertion torque(During implant placement)
- Surgery difficulty(During implant placement)
- Early Wound Healing(2 weeks post-surgery)
- Number of painkillers tablets(1-, 2-, 3-, 4-, 5-, 6-, 7 days post-operatively)
- Interproximal emergence(Loading visit (14 weeks after implant placement - 12 weeks until impression, delivery 2 weeks after impression))
- Insufficient inter-implant distance(Loading visit (14 weeks after implant placement - 12 weeks until impression, delivery 2 weeks after impression))
- Excessive subcrestal placement(Loading visit (14 weeks after implant placement - 12 weeks until impression, delivery 2 weeks after impression))
- Implant-shoulder exposure(Loading visit (14 weeks after implant placement - 12 weeks until impression, delivery 2 weeks after impression))
- Improper screw access hole(Loading visit (14 weeks after implant placement - 12 weeks until impression, delivery 2 weeks after impression))
- Probing Depth (PD)(From the loading visit, to 6 and 12 month follow-up visits)
- Suppuration on Probing (SUP)(From the loading visit, to 6 and 12 month follow-up visits)
- Keratinized Mucosa Width (KMW)(From the loading visit, to 6 and 12 month follow-up visits)
- Self Reported Pain(Immediately after surgery and 1-, 2-, 3-, 4-, 5-, 6-, 7 days post-operatively)
- General patient satisfaction(12-month visit)
- Radiographic marginal bone levels(Prosthetic loading visit (after loading of the prosthesis - which will be taken as the baseline measurement), 6 months after loading, and 12 months after loading.)