Angulated Screw-retained Crowns Following Immediate Implant Placement

Tooth Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160247
• Other study ID #: SH9-19-07
• Status: Completed
• Phase: Phase 3
• Start date: January 17, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: January 2021
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Diseases

Intervention

Procedure:
• Immediate implant placement
Implants are placed in fresh socket
• Angulated screw-retained crowns placement
To insert the restorations by angulated screw systems
• Cemented crowns placement
To cement the restorations onto the implant abutment

Locations

Country	Name	City	State
China	Shanghai NinthPeoples' Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOP%	Percentage of bleeding on probing positive	from baseline to 1-year follow-up
Secondary	PPD	Pocket probing depth	from baseline to 1-year follow-up
Secondary	MBL	Marginal bone loss	from baseline to 1-year follow-up
Secondary	PES	pink esthetic score	from baseline to 1-year follow-up