Angulated Screw-retained Crowns Following Immediate Implant Placement

NCT ID: NCT04160247

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2020-03-20

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.

Conditions

Tooth Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angulated screw-retained crown

Restorations are connected to the implants by angulated screw channel system

Group Type: ACTIVE_COMPARATOR

Immediate implant placement

Intervention Type: PROCEDURE

Implants are placed in fresh socket

Angulated screw-retained crowns placement

Intervention Type: PROCEDURE

To insert the restorations by angulated screw systems

Cemented crown

Restorations are cemented onto the implant abutment

Group Type: PLACEBO_COMPARATOR

Immediate implant placement

Intervention Type: PROCEDURE

Implants are placed in fresh socket

Cemented crowns placement

Intervention Type: PROCEDURE

To cement the restorations onto the implant abutment

Interventions

Immediate implant placement

Implants are placed in fresh socket

Intervention Type: PROCEDURE

Angulated screw-retained crowns placement

To insert the restorations by angulated screw systems

Intervention Type: PROCEDURE

Cemented crowns placement

To cement the restorations onto the implant abutment

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Junyu Shi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai NinthPeoples' Hospital

Shanghai, , China

Countries

China

Other Identifiers

SH9-19-07

Identifier Type: -

Identifier Source: org_study_id