Alveolar Bone Loss
Conditions
Brief summary
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
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.
Interventions
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.
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.
Sponsors
Alexandria University
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Neither the operator nor the participants could be blinded to the treatment type as the intervention procedures were markedly different between test and control groups. To enable blinding during outcome assessment, the stereolithography (STL) files of digitized casts were given a code different from that of the allocation procedure and were kept confidential. The volumetric analysis was performed and the groupings were shared with the biostatistician as groups A and B. Only during the interpretation the codes and groups were translated into test and control groups
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Patients had at least one localized horizontal ridge defect in a single tooth gap requiring soft tissue volume augmentation. 2. Teeth in the defect area have been extracted at least 3 months prior to enrolment 3. All patients were systemically healthy 4. Patients were non-smokers 5. Patients had abdominal fat accumulation allowing liposuction 6. Ability to understand the nature of the proposed surgery and ability to sign an informed consent form
Exclusion criteria
1. General contra-indications to surgical procedures 2. Pregnancy 3. Systemic diseases like Diabetes Mellitus and autoimmune diseases 4. History of malignancy, chemotherapy or radiotherapy within the last 5 years 5. Concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric analysis to evaluate soft tissue volume changes | 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | 1 month | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth |
| Clinical attachment loss (CAL) | 1 month | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth |
| Bleeding on probing | 1 month | measured using Michigan O probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent |
| Width of Keratinized tissue | 1 month | 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. |
Countries
Egypt
Outcome results
None listed