Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effectiveness of autologous fat as a grafting material for soft tissue volume augmentation of localized horizontal ridge defects in humans.

Detailed Description
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A total of 20 patients having 26 localized horizontal ridge defects were recruited for the study from the patient pool at the dental clinics of the faculty of dentistry, Alexandria University. Ridge defects were divided into two parallel groups: Test group: localized ridge defects were augmented using autologous fat grafting Control group: localized ridge defects were augmented using conventional subepithelial connective tissue graft.

Official Title
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Soft Tissue Volume Augmentation of Localized Horizontal Ridge Defects Using Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft (a Randomized Controlled Clinical Trial)

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Other: Autologous fat grafting
* Other: Sub-epithelial connective tissue graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients had at least one localized horizontal ridge defect in a single tooth gap requiring soft tissue volume augmentation. Teeth in the defect area have been extracted at least 3 months prior to enrolment All patients were systemically healthy Patients were non-smokers Patients had abdominal fat accumulation allowing liposuction Ability to understand the nature of the proposed surgery and ability to sign an informed consent form Exclusion Criteria: General contra-indications to surgical procedures Pregnancy Systemic diseases like Diabetes Mellitus and autoimmune diseases History of malignancy, chemotherapy or radiotherapy within the last 5 years Concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This non-inferiority study was designed as a randomized controlled clinical trial including 26 localized horizontal ridge defects that were equally allocated (1:1) into one of two parallel groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous fat grafting<br> | Other: Autologous fat grafting<br>* A fat graft will be aspirated from the abdomen under local anaesthesia and processed using the Microfat grafting technique. Afterwards the fat graft will be injected in the previously created pouch at the recipient site. Then the pouch will be closed using interrupted sutures 5-0 vicryl.<br>|
| Active Comparator: Sub-epithelial connective tissue graft<br> | Other: Sub-epithelial connective tissue graft<br>* A subepithelial connective tissue graft of a size that corresponds to that of the defect will be harvested from the palate using the trap door technique. The donor site will be closed using cross horizontal sling sutures and interrupted sutures 4-0 vicryl. Subsequently, the graft will be inserted in the previously created pouch at the recipient site and secured to the flap using vicryl sutures 5-0. Then the pouch will be closed using interrupted sutures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric analysis to evaluate soft tissue volume changes | To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies | 1 month | 
| Volumetric analysis to evaluate soft tissue volume changes | To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies | 2 months | 
| Volumetric analysis to evaluate soft tissue volume changes | To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth | 1 month | 
| Probing depth | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth | 2 months | 
| Probing depth | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth | 3 months | 
| Clinical attachment loss (CAL) | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth | 1 month | 
| Clinical attachment loss (CAL) | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth | 2 months | 
| Clinical attachment loss (CAL) | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth | 3 months | 
| Bleeding on probing | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent | 1 month | 
| Bleeding on probing | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent | 2 months | 
| Bleeding on probing | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent | 3 months | 
| Width of Keratinized tissue | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and it represents the edentulous span measured at the midpoint between teeth on either side of the edentulous space mesiodistally, starting at the buccal edge of the crest of the ridge till the mucogingival line. | 1 month | 
| Width of Keratinized tissue | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and it represents the edentulous span measured at the midpoint between teeth on either side of the edentulous space mesiodistally, starting at the buccal edge of the crest of the ridge till the mucogingival line. | 2 months | 
| Width of Keratinized tissue | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and it represents the edentulous span measured at the midpoint between teeth on either side of the edentulous space mesiodistally, starting at the buccal edge of the crest of the ridge till the mucogingival line. | 3 months |