Clinical Outcomes of Immediate Implant Placement and Early Implant Placement

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Outcomes of Immediate Implant Placement and Early Implant Placement: a Randomized Controlled Clinical Trial

Conditions
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Tooth Fractures, Tooth Diseases

Intervention / Treatment
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* Procedure: tooth extraction
* Procedure: Implant placement
* Procedure: Bone augmentation
* Procedure: Coronally repositioned flap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate implant placement<br>Implants are placed immediately after extraction | Procedure: tooth extraction<br>* Under local anesthesia, tooth will be extracted atraumatically.<br>Procedure: Implant placement<br>* Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.<br>Procedure: Bone augmentation<br>* Bone substitute will be used to augment or maintain the bone contour.<br>|
| Placebo Comparator: Early implant placement<br>Implants are placed 4-8 weeks after extraction | Procedure: tooth extraction<br>* Under local anesthesia, tooth will be extracted atraumatically.<br>Procedure: Implant placement<br>* Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.<br>Procedure: Bone augmentation<br>* Bone substitute will be used to augment or maintain the bone contour.<br>Procedure: Coronally repositioned flap<br>* After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 1-year follow-up | 
| Probing depth | Probing depth between crown delivery and 1-year follow-up | T2:crown delivery, T3: 1-year follow-up | 
| Bleeding on probing % | Bleeding on probing % between crown delivery and 1-year follow-up | T2:crown delivery, T3: 1-year follow-up | 
| Pink esthetic score |  | T2:crown delivery, T3: 1-year follow-up | 
| 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 |