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Angulated Screw-retained Crowns Following Immediate Implant Placement

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ClinicalTrials.gov Identifier: NCT04160247
Recruitment Status : Completed
First Posted : November 12, 2019
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Tooth Diseases Procedure: Immediate implant placement Procedure: Angulated screw-retained crowns placement Procedure: Cemented crowns placement Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Cemented and Angulated Screw-retained Crowns Following Immediate Implant Placement: a Randomized Controlled Clinical Trials
Actual Study Start Date : January 17, 2019
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Disorders

Arm Intervention/treatment
Active Comparator: Angulated screw-retained crown
Restorations are connected to the implants by angulated screw channel system
Procedure: Immediate implant placement
Implants are placed in fresh socket

Procedure: Angulated screw-retained crowns placement
To insert the restorations by angulated screw systems

Placebo Comparator: Cemented crown
Restorations are cemented onto the implant abutment
Procedure: Immediate implant placement
Implants are placed in fresh socket

Procedure: Cemented crowns placement
To cement the restorations onto the implant abutment




Primary Outcome Measures :
  1. BOP% [ Time Frame: from baseline to 1-year follow-up ]
    Percentage of bleeding on probing positive


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160247


Locations
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China
Shanghai NinthPeoples' Hospital
Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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Responsible Party: Junyu Shi, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT04160247    
Other Study ID Numbers: SH9-19-07
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases