Angulated Screw-retained Crowns Following Immediate Implant Placement

Phase 3

Completed

• Conditions: Tooth Diseases
• Interventions: Procedure: Immediate implant placement; Procedure: Cemented crowns placement; Procedure: Angulated screw-retained crowns placement

• Registration Number: NCT04160247
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-17
• Primary Completion: 2019-03-20
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Study Completion: 2020-03-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cemented crown	Immediate implant placement	Restorations are cemented onto the implant abutment
Cemented crown	Cemented crowns placement	Restorations are cemented onto the implant abutment
Angulated screw-retained crown	Angulated screw-retained crowns placement	Restorations are connected to the implants by angulated screw channel system
Angulated screw-retained crown	Immediate implant placement	Restorations are connected to the implants by angulated screw channel system

Primary Outcome Measures

Name	Time	Method
BOP%	from baseline to 1-year follow-up	Percentage of bleeding on probing positive

Secondary Outcome Measures

Name	Time	Method
MBL	from baseline to 1-year follow-up	Marginal bone loss
PPD	from baseline to 1-year follow-up	Pocket probing depth
PES	from baseline to 1-year follow-up	pink esthetic score

Trial Locations

Locations (1)

Shanghai NinthPeoples' Hospital; 🇨🇳 Shanghai, China