The One-piece Autologous Tuberosity Graft

Study Overview
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Brief Summary
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A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.

Detailed Description
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Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a one-piece dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software. Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.

Official Title
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The One-piece Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation

Conditions
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Healthy

Intervention / Treatment
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* Procedure: Socket preservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patient Patient with at least one single-rooted tooth to be extracted and be replaced with an implant No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding Non-smoker or Light Smoker < 10 cigarettes/day Exclusion Criteria: Pregnant or lactating females Non-controlled periodontal disease Medical conditions that contraindicate implant surgery Metabolic bone disorders such as osteoporosis,.. Severe psychiatric conditions Heavy smoker > 10 cigarettes/day

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Socket preservation group<br>Extraction sockets filled with a one-piece dual tissue graft harvested from the tuberosity using an adjusted trephine. | Procedure: Socket preservation<br>* 'One-Piece' autologous tuberosity graft combining hard and soft tissue, harvested from the maxillary tuberosity, placed in extraction sockets.<br>* Other names: autologous tuberosity graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of volume of the ridge from baseline to 4 months post-op | Volumetric variation of the ridge, measured on superimposed images of CBCT. | 4 months | 
| Change of Vertical dimension of the ridge from baseline to 4 months post-op | Linear Vertical variation of the ridge, measured on superimposed images of CBCT. | 4 months | 
| Change of Horizontal dimension of the ridge from baseline to 4 months post-op | Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT. | 4 months | 
| Change in Soft tissue from baseline to 4 months post-op | Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements) | Thickness of the keratinized mucosa on the buccal site, measured with a gauge caliper. | 4 months | 
| Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements) | Thickness of the keratinized mucosa on the crestal site, measured with a gauge caliper. | 4 months | 
| Change in Hard tissue from baseline to 4 months post-op (clinical measurements) | Horizontal dimension of the ridge (bucco-lingual) measured with a periodontal probe | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous, extraction, socket preservation, maxillary tuberosity, hard and soft tissue graft