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Angulated Screw-retained Crowns Following Immediate Implant Placement

Primary Purpose

Tooth Diseases

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Immediate implant placement
Angulated screw-retained crowns placement
Cemented crowns placement
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai NinthPeoples' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Angulated screw-retained crown

Cemented crown

Arm Description

Restorations are connected to the implants by angulated screw channel system

Restorations are cemented onto the implant abutment

Outcomes

Primary Outcome Measures

BOP%
Percentage of bleeding on probing positive

Secondary Outcome Measures

PPD
Pocket probing depth
MBL
Marginal bone loss
PES
pink esthetic score

Full Information

First Posted
November 8, 2019
Last Updated
January 22, 2021
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT04160247
Brief Title
Angulated Screw-retained Crowns Following Immediate Implant Placement
Official Title
Clinical Evaluation of Cemented and Angulated Screw-retained Crowns Following Immediate Implant Placement: a Randomized Controlled Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angulated screw-retained crown
Arm Type
Active Comparator
Arm Description
Restorations are connected to the implants by angulated screw channel system
Arm Title
Cemented crown
Arm Type
Placebo Comparator
Arm Description
Restorations are cemented onto the implant abutment
Intervention Type
Procedure
Intervention Name(s)
Immediate implant placement
Intervention Description
Implants are placed in fresh socket
Intervention Type
Procedure
Intervention Name(s)
Angulated screw-retained crowns placement
Intervention Description
To insert the restorations by angulated screw systems
Intervention Type
Procedure
Intervention Name(s)
Cemented crowns placement
Intervention Description
To cement the restorations onto the implant abutment
Primary Outcome Measure Information:
Title
BOP%
Description
Percentage of bleeding on probing positive
Time Frame
from baseline to 1-year follow-up
Secondary Outcome Measure Information:
Title
PPD
Description
Pocket probing depth
Time Frame
from baseline to 1-year follow-up
Title
MBL
Description
Marginal bone loss
Time Frame
from baseline to 1-year follow-up
Title
PES
Description
pink esthetic score
Time Frame
from baseline to 1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Shanghai NinthPeoples' Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China

12. IPD Sharing Statement

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Angulated Screw-retained Crowns Following Immediate Implant Placement

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