Gingival Recession, Generalized, Graft Reaction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREGingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation
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.
Sponsors
Dentsply Implants Manufacturing GmbH
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* general healthy * periodontal healthy (no PD \>3mm, no BOP, no mobility at the test site and control site) * patients identified need gingival biotype modification (need for increased tissue thickness) during the periodontal exam or referred from orthodontics
Exclusion criteria
* current smoker or smoking history * taking Antibiotics or medicines within the last 3 months * past history of gingival soft tissue augmentation/modification surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The histological analysis of the gingival biopsy tissue. | Month 3---after the gingival biopsy procedures | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The immunohistological analysis of the gingival biopsy. | Month 3---after the gingival biopsy procedures | 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. |
| RT-qPCR analysis of gingival biopsy. | Month 3---after the gingival biopsy procedures | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in the gingival biotype analysis before and after grafting surgery | Baseline; Month 3 (before the gingival grafting surgery and before the gingival biopsy which is 3 months after gingival 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. |
| The healing time of the gingival biopsy sites | Up to 7 days after gingival biopsy | The gingival wound healing after biopsy will be compared between the sites |
Outcome results
None listed