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| Name | Class |
|---|---|
| Alexandria University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous fat grafting | Experimental |
| |
| Sub-epithelial connective tissue graft | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous fat grafting | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasmine Gaweesh, PhD | Faculty of Dentistry, Alexandria University, Egypt | Principal Investigator |
| Maha A Abou Khadr, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Chair |
| Hussein S Abulhassan, PhD | Faculty of Medicine, Alexandria University, Egypt | Study Chair |
| Nesma M Khalil, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12423299 | Background | Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x. | |
| 24720375 | Background | Akcali A, Schneider D, Unlu F, Bicakci N, Kose T, Hammerle CH. Soft tissue augmentation of ridge defects in the maxillary anterior area using two different methods: a randomized controlled clinical trial. Clin Oral Implants Res. 2015 Jun;26(6):688-95. doi: 10.1111/clr.12368. Epub 2014 Apr 10. |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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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.
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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
|
| Sub-epithelial connective tissue graft | Other | 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. |
|
| 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 |
| 28107560 | Background | Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11. |
| 24163528 | Background | Marwah M, Kulkarni A, Godse K, Abhyankar S, Patil S, Nadkarni N. Fat Ful'fill'ment: A Review of Autologous Fat Grafting. J Cutan Aesthet Surg. 2013 Jul;6(3):132-8. doi: 10.4103/0974-2077.118402. |
| 23732072 | Background | Alharbi Z, Oplander C, Almakadi S, Fritz A, Vogt M, Pallua N. Conventional vs. micro-fat harvesting: how fat harvesting technique affects tissue-engineering approaches using adipose tissue-derived stem/stromal cells. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1271-8. doi: 10.1016/j.bjps.2013.04.015. Epub 2013 Jun 2. |
| 29334403 | Background | Rojo E, Stroppa G, Sanz-Martin I, Gonzalez-Martin O, Alemany AS, Nart J. Soft tissue volume gain around dental implants using autogenous subepithelial connective tissue grafts harvested from the lateral palate or tuberosity area. A randomized controlled clinical study. J Clin Periodontol. 2018 Apr;45(4):495-503. doi: 10.1111/jcpe.12869. Epub 2018 Feb 23. |
| 24341747 | Background | Schneider D, Ender A, Truninger T, Leutert C, Sahrmann P, Roos M, Schmidlin P. Comparison between clinical and digital soft tissue measurements. J Esthet Restor Dent. 2014 May-Jun;26(3):191-9. doi: 10.1111/jerd.12084. Epub 2013 Dec 17. |
| 17590160 | Background | Windisch SI, Jung RE, Sailer I, Studer SP, Ender A, Hammerle CH. A new optical method to evaluate three-dimensional volume changes of alveolar contours: a methodological in vitro study. Clin Oral Implants Res. 2007 Oct;18(5):545-51. doi: 10.1111/j.1600-0501.2007.01382.x. Epub 2007 Jun 21. |
| 19419446 | Background | Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hurzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x. |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |