Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

Study Overview
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Brief Summary
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The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.

Detailed Description
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The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a ﬁnal impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Official Title
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Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla

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

Intervention / Treatment
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* Procedure: buccal bone augmentation


Participation Criteria
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Eligibility Criteria
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The inclusion criteria were as follows: 18 to 70-year-old; Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II); Single maxillary anterior teeth (canine to canine); Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)； Presence of adjacent nature tooth; Good compliance; No palatal vertical bone loss; Good oral hygiene. Exclusion criteria are as follow: Uncontrolled periodontal or systemic disease; General psychiatric contraindications; More than 20 cigarettes per day; History of head and neck radiotherapy； Pregnant or expecting to be pregnant; Patients with local or generalized healing limitations; Bruxism or other destructive parafunctional habits; Drug abuse or alcohol abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thin or dehiscences buccal plate<br>Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate. | Procedure: buccal bone augmentation<br>* Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone volume | Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 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 |
| --- | --- | --- |
| Change of 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. | Change from baseline up to 10 years after implantation | 
| 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 | 
| 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 | 
| 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 | 

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