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Angulated Screw-retained Crowns Following Immediate Implant Placement

Clinical Evaluation of Cemented and Angulated Screw-retained Crowns Following Immediate Implant Placement: a Randomized Controlled Clinical Trials

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04160247
Enrollment
40
Registered
2019-11-12
Start date
2019-01-17
Completion date
2020-03-20
Last updated
2021-01-25

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

Conditions

Tooth Diseases

Brief summary

There are two choices of restorations and implant abutments connection now: cemented and screw-retained.The excess cement, which would be difficult to completely remove, might lead to series of biological complications. The angulated screw channel (ASC) abutments, which recently introduced by Nobel Biocare , largely address the problem with visible screw access that may compromise esthetics. However, all of the present studies were clinical reports, thus the clinical efficacy of ASC abutments still needs the verification of evidence-based medicine with larger sample. Therefore, we designed a randomized controlled clinical trial study, aiming to verify the clinical efficacy of the ASC abutments by comparing screw-retained (with ASC abutments) single implant crowns with cemented ones in esthetic region.

Interventions

PROCEDUREImmediate implant placement

Implants are placed in fresh socket

PROCEDUREAngulated screw-retained crowns placement

To insert the restorations by angulated screw systems

PROCEDURECemented crowns placement

To cement the restorations onto the implant abutment

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ≥18 years old and in good health; 2. Single tooth implant (type 1) in the esthetic region; 3. Patients with natural teeth adjacent to single implant crowns; 4. Patients with periodontal treatment before implant surgery; 5. The implants are from Nobel Biocare system with tapered link and the permanent restoration is a single crown and all-ceramic; 6. Soft tissue in the implanting-and-adjacent areas is healthy and free of infection

Exclusion criteria

1. Multiple implants in the esthetic region, or the restoration is a bridge 2. Patients with bone augmentation procedures; 3. Heavy smokers (\>10 cigarettes/day); 4. Medically compromised patients (American Society of Anesthesiologists (ASA) classification III-IV); 5. Implants in an incorrect three-dimensional position (definition according to ITI VOL1); 6. Uncontrolled diabetes mellitus; 7. Unwilling to participate in the present study.

Design outcomes

Primary

MeasureTime frameDescription
BOP%from baseline to 1-year follow-upPercentage of bleeding on probing positive

Secondary

MeasureTime frameDescription
PPDfrom baseline to 1-year follow-upPocket probing depth
MBLfrom baseline to 1-year follow-upMarginal bone loss
PESfrom baseline to 1-year follow-uppink esthetic score

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026