Clinical Outcomes of Immediate Implant Placement and Early Implant Placement
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJanuary 25, 2021
January 1, 2021
2.4 years
July 7, 2019
January 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Midfacial recession
Recession of midfacial gingival level before extraction and 1-year follow-up
1-year follow-up
Secondary Outcomes (6)
Papillae recession
1-year follow-up
marginal bone loss
1-year follow-up
Probing depth
T2:crown delivery, T3: 1-year follow-up
Bleeding on probing %
T2:crown delivery, T3: 1-year follow-up
Pink esthetic score
T2:crown delivery, T3: 1-year follow-up
- +1 more secondary outcomes
Study Arms (2)
Immediate implant placement
ACTIVE COMPARATORImplants are placed immediately after extraction
Early implant placement
PLACEBO COMPARATORImplants are placed 4-8 weeks after extraction
Interventions
Under local anesthesia, tooth will be extracted atraumatically.
Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.
Bone substitute will be used to augment or maintain the bone contour.
After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position
Eligibility Criteria
You may qualify if:
- age ≧18 years
- single hopeless teeth in anterior maxilla
- enough apical bone volume to achieve primary stability (\>4mm)
You may not qualify if:
- active periodontoal infection
- incomplete buccal bone plate
- unwilling to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai NinthPeoples' Hospital
Shanghai, 200011, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, clinical professor,Department of Implant Dentistry
Study Record Dates
First Submitted
July 7, 2019
First Posted
July 23, 2019
Study Start
July 15, 2019
Primary Completion
December 1, 2021
Study Completion
October 1, 2022
Last Updated
January 25, 2021
Record last verified: 2021-01