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| Name | Class |
|---|---|
| Universidade Estadual de Maringá | OTHER |
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This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.
The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6, 12 months and 8 years after surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Free Gingival Graft | Experimental | Twenty patients will receive the modified free gingival graft technique at the inferior incisors area. In this technique, the graft is covered by a flap, similarly to what is done in a connective tissue graft surgery. |
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| Original Free Gingival Graft technique | Active Comparator | Twenty patients will receive the original technique of free gingival graft at the inferior incisors area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free Gingival Graft | Procedure | Surgical technique (autologous graft): Free gingival graft technique, harvested from palate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Apical-cervical width of keratinized tissue after 12 months | Distance between gingival margin and mucogingival junction, in millimeters | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth | Distance between gingival margin and bottom of the sulcus / pocket, in millimeters | 12 months |
| Keratinized tissue area | Keratinized tissue area, measured in millimeters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio M Pannuti, PhD | University of Sao Paulo | Principal Investigator |
| João Batista C Neto, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Odontologia da USP | São Paulo | São Paulo | 05508-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38950768 | Result | Cesar Neto JB, Cavalcanti MC, Silva CO, Almeida VC, Sapata VM, Lazarin RO, Jung R, Romito GA, Tatakis DN, Pannuti CM. Digital three-dimensional assessment of free gingival graft remodeling over 12 months. J Dent. 2024 Sep;148:105216. doi: 10.1016/j.jdent.2024.105216. Epub 2024 Jun 29. | |
| 36629587 | Result | Almeida VC, Pannuti CM, Ferreira MS, Lazarin RO, Romito GA, Jung RE, Tatakis DN, Silva COE, Cesar Neto JB. Conventional versus flap-protected free gingival graft: a multicenter randomized clinical trial. Braz Oral Res. 2023 Jan 6;37:e001. doi: 10.1590/1807-3107bor-2023.vol37.0001. eCollection 2023. |
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| Original Free Gingival Graft technique | Procedure | Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area |
|
| Modified Free Gingival Graft technique | Procedure | Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area |
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| 12 months |
| Keratinized tissue thickness | Keratinized tissue thickness measured in millimeters | 12 months |
| Volume of receiving area | Volume of receiving area | 12 months |
| Complete epithelization of donor area | Area of Epithelization of wound healing, measured in mm2 | 28 days |
| Postoperative discomfort | discomfort measured using Visual Analogue Scale | 28 days |
| Gum color | Measured with photographic analysis | 12 months |
| Oral Health Related Quality of Life (OHIP) | OHIp - 14 short version | 12 months |
| Clinical Attachment Level | Distance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters | 12 months |
| Recession | Distance between cementum-enamel junction and gingival margin, measured in millimeters | 12 months |
| Bleeding on probing | percentage of sites which bled upon probing | 12 months |
| 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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