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Clinical Trials/NCT04160247
NCT04160247
Completed
Phase 3

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country40 target enrollmentJanuary 17, 2019
ConditionsTooth Diseases

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Tooth Diseases
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment
40
Locations
1
Primary Endpoint
BOP%
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 17, 2019
End Date
March 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible Party
Principal Investigator
Principal Investigator

Junyu Shi

Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

BOP%

Time Frame: from baseline to 1-year follow-up

Percentage of bleeding on probing positive

Secondary Outcomes

  • MBL(from baseline to 1-year follow-up)
  • PPD(from baseline to 1-year follow-up)
  • PES(from baseline to 1-year follow-up)

Study Sites (1)

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