Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement

Study Overview
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Brief Summary
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The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.

Detailed Description
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Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios.

Official Title
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Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla

Conditions
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Jaw, Edentulous, Partially, Acquired Absence of Single Tooth

Intervention / Treatment
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* Procedure: Type 1 implant placement
* Procedure: Type 3 implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old and able to understand an informed consent Adequate oral hygiene to allow for implant therapy consistent with standards of care. Missing a single tooth in the maxillary anterior region Presence of adjacent natural teeth Exclusion Criteria: Poor oral hygiene Severe parafunctional habits, for example, bruxing and clenching Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing. Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease Pregnant or expecting to be pregnant History of drug and alcohol abuse History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%) Radiotherapy in the head and neck area, On certain medications like bisphosphonates or steroids currently or within the past three months Absence of adjacent teeth Unwillingness to return for the follow-up examination Smokers (more than 20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Type 1 implant placement<br>Implant is placed immediately following tooth extraction in one surgical procedure | Procedure: Type 1 implant placement<br>* Implant is placed immediately following tooth extraction in one surgical procedure<br>* Other names: Immediate implant placement;|
| Active Comparator: Type 3 implant placement<br>Implant is placed in the site which is left to heal for 3 months following tooth extraction | Procedure: Type 3 implant placement<br>* Implant is placed in the site which is left to heal for 3 months following tooth extraction<br>* Other names: Delayed implant placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pink and white esthetic scores (PES/WES) | Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Radiographic bone volume | Radiographic bone volume be assessed at pre-operation, 0 ,1.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Probing depth | Probing depth will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Modified plaque index | Modified plaque index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Modified bleeding index | Modified bleeding index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Buccal marginal recession | Buccal marginal recession will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Papilla volume | Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Width of keratinized gingiva | Width of keratinized gingiva will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Visual analogue scale (VAS) | A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 
| Oral health impact profile shortened version (OHIP-I) | A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. | Up to 10 years after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delayed implant, esthetics, immediate implant, bone augmentation