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Completed

NCT Number: NCT04160247

Angulated Screw-retained Crowns Following Immediate Implant Placement

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.

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Key information

Conditions

Tooth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai NinthPeoples' Hospital

Shanghai, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate Implant Placement

Procedure

Implants are placed in fresh socket

Angulated screw-retained crowns placement

Procedure

To insert the restorations by angulated screw systems

Cemented crowns placement

Procedure

To cement the restorations onto the implant abutment

Primary outcomes

  1. BOP%

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

    Percentage of bleeding on probing positive

Secondary outcomes

  1. PPD

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

    Pocket probing depth

  2. MBL

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

    Marginal bone loss

  3. PES

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

    pink esthetic score

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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