Clinical Outcomes of Immediate Implant Placement and Earl... | NCT04029324

Studies
Clinical Outcomes of Immediate Implant Placement and Early Implant Placement

NCT04029324

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Unknown status

Last Update Posted

Jan 25, 2021Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Tooth Fractures
Tooth Diseases

Interventions

tooth extraction
Implant placement
Bone augmentation
Coronally repositioned flap

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2019Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Oct 1, 2022Estimated

First Submitted Date

Jul 7, 2019

First Submission Date that Met QC Criteria

Jul 22, 2019

First Posted Date

Jul 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2021

Last Update Posted Date

Jan 25, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Junyu Shi, Principal investigator, clinical professor,Department of Implant Dentistry, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate implant placement	Active Comparator	Implants are placed immediately after extraction	Procedure: tooth extraction Procedure: Implant placement Procedure: Bone augmentation
Early implant placement	Placebo Comparator	Implants are placed 4-8 weeks after extraction	Procedure: tooth extraction Procedure: Implant placement Procedure: Bone augmentation Procedure: Coronally repositioned flap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tooth extraction	Procedure	Under local anesthesia, tooth will be extracted atraumatically.	Early implant placement Immediate implant placement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Midfacial recession	Recession of midfacial gingival level before extraction and 1-year follow-up	1-year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Papillae recession	Recession of papillae before extraction and 1-year follow-up	1-year follow-up
marginal bone loss	marginal bone level between crown delivery and 1-year follow-up

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Junyu Shi, Phd	Contact	8653315299		sakyamuni_jin@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai NinthPeoples' Hospital	Recruiting	Shanghai		200011	China

Condition Browse Module

MeSH Terms

ID	Term
D014082	Tooth Fractures
D014076	Tooth Diseases

Ancestor Terms

ID	Term
D018677	Tooth Injuries
D009057	Stomatognathic Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014081	Tooth Extraction

Ancestor Terms

ID	Term
D019647	Oral Surgical Procedures
D013514	Surgical Procedures, Operative
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided