Angulated Screw-retained Crowns Following Immediate Implant Placement

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Diseases
• Intervention / Treatment: Procedure: Immediate implant placement; Procedure: Angulated screw-retained crowns placement; Procedure: Cemented crowns placement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200011
    • Shanghai NinthPeoples' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOP%	Percentage of bleeding on probing positive	from baseline to 1-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPD	Pocket probing depth	from baseline to 1-year follow-up
MBL	Marginal bone loss	from baseline to 1-year follow-up
PES	pink esthetic score	from baseline to 1-year follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2019
• Primary Completion (ACTUAL): March 20, 2019
• Study Completion (ACTUAL): March 20, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (ACTUAL): November 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: SH9-19-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No