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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04029324
Other study ID # 136-2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date October 1, 2022

Study information

Verified date January 2021
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact Junyu Shi, Phd
Phone 8653315299
Email sakyamuni_jin@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
tooth extraction
Under local anesthesia, tooth will be extracted atraumatically.
Implant placement
Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.
Bone augmentation
Bone substitute will be used to augment or maintain the bone contour.
Coronally repositioned flap
After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position

Locations

Country Name City State
China Shanghai NinthPeoples' Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Midfacial recession Recession of midfacial gingival level before extraction and 1-year follow-up 1-year follow-up
Secondary Papillae recession Recession of papillae before extraction and 1-year follow-up 1-year follow-up
Secondary marginal bone loss marginal bone level between crown delivery and 1-year follow-up 1-year follow-up
Secondary Probing depth Probing depth between crown delivery and 1-year follow-up T2:crown delivery, T3: 1-year follow-up
Secondary Bleeding on probing % Bleeding on probing % between crown delivery and 1-year follow-up T2:crown delivery, T3: 1-year follow-up
Secondary Pink esthetic score T2:crown delivery, T3: 1-year follow-up
Secondary Visual Analogue Scale assessement Visual Analogue Scale on post-operative pain, esthetics and function T1: immediately after surgery,T2:crown delivery, T3: 1-year follow-up
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