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Withdrawn with IRB
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| Name | Class |
|---|---|
| Dentsply Implants Manufacturing GmbH | INDUSTRY |
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The study team proposes to prospectively compare the healing outcomes of autogenous soft tissue connective tissue graft (CTG) and Acellular dermis matrix (ADM) in a split-mouth design study for patients requiring modification of gingival soft tissue biotype. The researchers aim to investigate the earlier phase of graft healing after the grafting surgery by biopsy histology and by examining the alteration of gene profile during the healing of gingival tissue healing by molecular cell biological techniques.
The investigators will perform a prospective clinical randomized controlled trial, and recruit 12 patients who need gingival soft tissue augmentation. It is a split-mouth design: CTG will be used in one side of soft tissue augmentation, and ADM will be used on the other side. 3 months after graft healing, clinical measurements including soft tissue thickness, transparency visualization, tissue profile record with impression cast study model, and digital photography of tissue will be performed. The gingival punch biopsies ( 2mm diameters) will be performed in both sides of grafting areas under the local oral anesthesia injection. The collected tissue will be split into two halves, one for histological examination, and another half for gene analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTG Group | Active Comparator | Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the autogenous connective tissue graft (CTG) material will be randomized to transplant to one side of the arch. |
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| ADM Group | Active Comparator | The patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the commercial acellular dermal matrix (ADM) materials will be transplanted to the opposite side of the arch with CTG transplants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation | Procedure | Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half. After 3 months of healing, a gingival punch biopsy will be performed in both sides to collect the tissues for analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| The histological analysis of the gingival biopsy tissue. | Histological analysis with standard coloration will assess the epithelium and underneath connective tissue within the gingival biopsy tissue. Signs of inflammation (ulcerations, infiltration of neutrophil cells, vessel structure) will be noted. | Month 3---after the gingival biopsy procedures |
| Measure | Description | Time Frame |
|---|---|---|
| The immunohistological analysis of the gingival biopsy. | Immunohistological analysis using specific antibodies will locate the epithelium (collagen IV), the smooth muscle (Smooth muscle actin), and re-innvervation (protein gene product 9.5, calcitonin-related gene product) according to the similar study by Perotto, et al. 2017. | Month 3---after the gingival biopsy procedures |
| Measure | Description | Time Frame |
|---|---|---|
| change in the gingival biotype analysis before and after grafting surgery | The gingival thickness measurement by visualization with periodontal probing, the soft tissue profile analysis with dental casts and digital photographs will be performed before the gingival grafting surgery and before the gingival biopsy which is 3 months after gingival grafting surgery. | Baseline; Month 3 (before the gingival grafting surgery and before the gingival biopsy which is 3 months after gingival grafting surgery) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jia Chang, DDS, MS, PhD | University of Florida College of Dentistry, Department of Periodontology | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24597764 | Background | McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5. | |
| 15974840 | Background | Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178. |
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The individual participant data sets are to be shared include all collected IPD, all IPD that underlie results in a publication
The data will be available once the summary data are published.
The PI will review requests and criteria for reviewing requests.
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Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half.
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The biopsy sites will be coded alphanumerically. The investigator performing the gingival grafts will be different from the examiner performing the gingival biopsies. The examiner performing the gingival biopsies will be blinded to the grafting type source of the biopsy sites.The results from coded samples will be reported to the PI, who will summarize the data.
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| RT-qPCR analysis of gingival biopsy. | The RT-qPCR analysis will measure the level of expression (compared to the housekeeping gene GAPDH) of RNA specific to the epithelium (collagen IV), the smooth muscle (Smooth muscle actin), re-innvervation (protein gene product 9.5, calcitonin-related gene product) and inflammation (IL-1, IL-6, MMP-8, TNF-alpha). | Month 3---after the gingival biopsy procedures |
| The healing time of the gingival biopsy sites | The gingival wound healing after biopsy will be compared between the sites | Up to 7 days after gingival biopsy |
| 29713889 | Background | de Resende DRB, Greghi SLA, Siqueira AF, Benfatti CAM, Damante CA, Ragghianti Zangrando MS. Acellular dermal matrix allograft versus free gingival graft: a histological evaluation and split-mouth randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):539-550. doi: 10.1007/s00784-018-2470-6. Epub 2018 Apr 30. |
| 29731940 | Background | Menceva Z, Dimitrovski O, Popovska M, Spasovski S, Spirov V, Petrushevska G. Free Gingival Graft versus Mucograft: Histological Evaluation. Open Access Maced J Med Sci. 2018 Mar 27;6(4):675-679. doi: 10.3889/oamjms.2018.127. eCollection 2018 Apr 15. |
| 11922254 | Background | Wei PC, Laurell L, Lingen MW, Geivelis M. Acellular dermal matrix allografts to achieve increased attached gingiva. Part 2. A histological comparative study. J Periodontol. 2002 Mar;73(3):257-65. doi: 10.1902/jop.2002.73.3.257. |
| 28609502 | Background | Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020. |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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