Patients' perception of the immediate restoration of posterior single implants by an innovative fully digital one-abutment/one-time concept (SafetyCrown) compared with the standard procedure (submerged healing) - A randomized controlled clinical trial

Patients' perception of the immediate restoration of posterior single implants by an innovative fully digital one-abutment/one-time concept (SafetyCrown) compared with the standard procedure (submerged healing) - A randomized controlled clinical trial - SafetyCrown

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027484

Enrollment

Registered

2022-06-17

Start date

2022-08-02

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

K08.1

Interventions

Group 1: Usage of the SafetyCrown-protocol (Immediate restoration) Group 2: rehabilitation with the standard procedure (submerged healing, control group)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: informed consent, plaque index (O'Leary <25%), non or low smokers, single-tooth gap posterior of the canine or edentulism posterior of the first premolar (if shortened dental arch is possible) or posterior of the second premolar with sufficient support of the opposing dentition, healed ridge, anatomic conditions predict high primary stability suitable for immediate restoration, sufficient bone volume and imterproximal distance for the placement of a dental implant minimum diameter 3.75mm, length 8mm (Straumann BLX) without the need of augmentation

Exclusion criteria

Exclusion criteria: systemic diseases and/or medical interacting with bone or soft-tissue healing, previous irradiation, present contraindivations for elective intraoral surgical procedures, smoking >10 zig/d, substance abuse, uncontrolled diabetes mellitus, pregnant or breastfeeding woman, untreated edentulism in the opposing dentition, pocet depth of >=4mm on one of the immediate adjacent teeth (active periodontitis), need for major bone augmentation, serve bruxism, absence of keratinized soft tissue

Design outcomes

Primary

Measure	Time frame
Patient-related Outcome Measures (PROMs, visual analoge scale, questionnaire)	—

Secondary

Measure	Time frame
Time efficiency (timing of treatment and laboratory procedures), accuracy analysis of navigated implant placement (superimpositioning of intraoral scans), marginal bone loss (radiological), clinical performance and aesthetics (various parameters screened by accessor)	—

Countries

Germany

Contacts

Public ContactLukas Waltenberger

Universitätsklinikum Aachen, Klinik für zahnärztliche Prothetik und Biomaterialien, Zentrum für Implantologie

lwaltenberge@ukaachen.de+492418088299

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026