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Comparison of loading protocols under a full-digital workflow

Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007935
Enrollment
62
Registered
2022-11-24
Start date
2022-01-31
Completion date
Unknown
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : A person who voluntarily signs a clinical research agreement and satisfies the selection criteria is enrolled in this clinical study. Subjects were randomly assigned to the experi

Sponsors

Zurich University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. = 18 years of age 2. In need of at least two or more unilateral implants at the posterior region either in the maxilla or the mandible (excl. third molars) (single crowns only) 3. Primary implant stability with insertion torque > 30N 4. Presence of two adjacent teeth at the implant site 5. Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%); 6. Capability to comply with the study procedures 7. Signed Informed Consent Form

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women 2. Systemic or local conditions presenting a contraindication to implant treatment 3. Known or suspected non-compliance, drug or alcohol abuse 4. Smokers (>10 cigarettes/day) 5. Currently taking drugs that influence bone metabolism 6. Use of bisphosphonates in the last 4 years 7. History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years

Design outcomes

Primary

MeasureTime frame
Patients’ satisfaction using Patient Reported Outcome Measures (PROMs) (VAS), after 12 months

Secondary

MeasureTime frame
Profilometric changes of the buccal soft tissues via superimposing the digital impressions;Accuracy of implant position by means of cone-beam CT;Fit of final reconstruction measured by the need for adjustment either by the dentist or the dental technician;Technical outcomes (efficacy/USPHS) after insertion of the final reconstruction, and at 1-year follow-up;Patient’s reported outcome measures;Perceived difficulty/ease of use rated by dentists at implant placement and at the visit for Final Prosthesis (BL1 and BL2);Efficiency (time) assessed at implant placement and at visit of Final Prosthesis (BL1 and BL2);Marginal bone level (implant shoulder to first bone-to-implant-contact) after final reconstruction (at visits for Evaluation of Final Prosthesis), 6 months and 1-year follow-up;Implant survival at 6 months and 1-year follow-up;Schedule of visits and additional visits (efficiency);Treatment cost;Peri-implant clinical parameters (PD, REC and KER, PI, BOP) at the implant sites and adjacent teeth

Countries

Korea, Republic of

Contacts

Public ContactDaMi Kim

Yonsei University Health System, Dental Hospital

ekal7765@naver.com+82-2-2228-2953

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026