Angulated Screw-retained Crowns Following Immediate Implant Placement

NCT04160247 | Completed Phase 3 DMC

• 1 other identifier: SH9-19-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• BOP%

  Percentage of bleeding on probing positive

  from baseline to 1-year follow-up

Secondary Outcomes (3)

• PPD

  from baseline to 1-year follow-up

• MBL

  from baseline to 1-year follow-up

• PES

  from baseline to 1-year follow-up

Study Arms (2)

Angulated screw-retained crown

ACTIVE COMPARATOR

Restorations are connected to the implants by angulated screw channel system

Procedure: Immediate implant placement; Procedure: Angulated screw-retained crowns placement

Cemented crown

PLACEBO COMPARATOR

Restorations are cemented onto the implant abutment

Procedure: Immediate implant placement; Procedure: Cemented crowns placement

Interventions

Immediate implant placement PROCEDURE

Implants are placed in fresh socket

Angulated screw-retained crown; Cemented crown

Angulated screw-retained crowns placement PROCEDURE

To insert the restorations by angulated screw systems

Angulated screw-retained crown

Cemented crowns placement PROCEDURE

To cement the restorations onto the implant abutment

Cemented crown

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai NinthPeoples' Hospital

Shanghai, 200011, China

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: January 17, 2019
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

CN (1)