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Clinical Outcomes of Immediate Implant Placement and Early Implant Placement

Primary Purpose

Tooth Fractures, Tooth Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tooth extraction
Implant placement
Bone augmentation
Coronally repositioned flap
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 Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age ≧18 years
  • single hopeless teeth in anterior maxilla
  • enough apical bone volume to achieve primary stability (>4mm)

Exclusion Criteria:

  • active periodontoal infection
  • incomplete buccal bone plate
  • unwilling to participate

Sites / Locations

  • Shanghai NinthPeoples' HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Immediate implant placement

Early implant placement

Arm Description

Implants are placed immediately after extraction

Implants are placed 4-8 weeks after extraction

Outcomes

Primary Outcome Measures

Midfacial recession
Recession of midfacial gingival level before extraction and 1-year follow-up

Secondary Outcome Measures

Papillae recession
Recession of papillae before extraction and 1-year follow-up
marginal bone loss
marginal bone level between crown delivery and 1-year follow-up
Probing depth
Probing depth between crown delivery and 1-year follow-up
Bleeding on probing %
Bleeding on probing % between crown delivery and 1-year follow-up
Pink esthetic score
Visual Analogue Scale assessement
Visual Analogue Scale on post-operative pain, esthetics and function

Full Information

First Posted
July 7, 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
NCT04029324
Brief Title
Clinical Outcomes of Immediate Implant Placement and Early Implant Placement
Official Title
Clinical Outcomes of Immediate Implant Placement and Early Implant Placement: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

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
Immediate implant placement (IIP) has been an attractive treatment concept for both patients and clinicians due to reduced surgical interventions and total treatment span. Although soft-tissue alterations or midfacial recession have been demonstrated in previous studies, recent studies have reported positive result following IIP with the modification of surgical interventions. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of IIP with early implant placement (type 2) is limited.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate implant placement
Arm Type
Active Comparator
Arm Description
Implants are placed immediately after extraction
Arm Title
Early implant placement
Arm Type
Placebo Comparator
Arm Description
Implants are placed 4-8 weeks after extraction
Intervention Type
Procedure
Intervention Name(s)
tooth extraction
Intervention Description
Under local anesthesia, tooth will be extracted atraumatically.
Intervention Type
Procedure
Intervention Name(s)
Implant placement
Intervention Description
Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.
Intervention Type
Procedure
Intervention Name(s)
Bone augmentation
Intervention Description
Bone substitute will be used to augment or maintain the bone contour.
Intervention Type
Procedure
Intervention Name(s)
Coronally repositioned flap
Intervention Description
After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position
Primary Outcome Measure Information:
Title
Midfacial recession
Description
Recession of midfacial gingival level before extraction and 1-year follow-up
Time Frame
1-year follow-up
Secondary Outcome Measure Information:
Title
Papillae recession
Description
Recession of papillae before extraction and 1-year follow-up
Time Frame
1-year follow-up
Title
marginal bone loss
Description
marginal bone level between crown delivery and 1-year follow-up
Time Frame
1-year follow-up
Title
Probing depth
Description
Probing depth between crown delivery and 1-year follow-up
Time Frame
T2:crown delivery, T3: 1-year follow-up
Title
Bleeding on probing %
Description
Bleeding on probing % between crown delivery and 1-year follow-up
Time Frame
T2:crown delivery, T3: 1-year follow-up
Title
Pink esthetic score
Time Frame
T2:crown delivery, T3: 1-year follow-up
Title
Visual Analogue Scale assessement
Description
Visual Analogue Scale on post-operative pain, esthetics and function
Time Frame
T1: immediately after surgery,T2:crown delivery, T3: 1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age ≧18 years single hopeless teeth in anterior maxilla enough apical bone volume to achieve primary stability (>4mm) Exclusion Criteria: active periodontoal infection incomplete buccal bone plate unwilling to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junyu Shi, Phd
Phone
8653315299
Email
sakyamuni_jin@163.com
Facility Information:
Facility Name
Shanghai NinthPeoples' Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Zhang, Master
Phone
8623271699

12. IPD Sharing Statement

Learn more about this trial

Clinical Outcomes of Immediate Implant Placement and Early Implant Placement

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