Compares treatment options for Dental Implant
Official title Accuracy of Static Guided Implant Surgery: 3D-printed vs Milled Surgical Guides
ClinicalTrials.gov ID: NCT06819995
What this study is testing
- What it's testing
- Dear Patient, You are invited to participate in a clinical study. To understand the study, please carefully review the following information.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Male or female patients with one to four missing teeth, where dental implants are planned and where a tooth-supported or tooth-mucosal supported...
- 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...
- 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...
You likely can't join if
- Systemic
- 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).
See the full eligibility criteria
- 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...
- 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...
- 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.
- Systemic
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.