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The objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique (MCAT) with either conventional CTG (control group) or micro-CTG (test group).
Gingival recession defects (GRD) present as a partial exposure of the root surface resulting from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As the presence of thin gingival tissues is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) during the surgical correction is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage (documented range: 69% to 97%). The procedure does, however, require a suitable donor site. When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical procedures may even be necessary. As an alternative, a modification of the harvested CTG into multiple "micro-CTGs" is proposed for the treatment of multiple adjacent GRDs (MAGRD). In the present study, the effectiveness and predictability of micro-CTGs will be evaluated in direct comparison to conventional CTGs.
The investigators hypothesise that no statistically significant differences will be observed in terms of % root coverage (primary outcome) and patient satisfaction at 12 months (non-inferiority).
The investigators hypothesise that subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective Tissue Graft | Active Comparator | A mucogingival surgery where a conventional connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects. |
|
| Micro Connective Tissue Graft | Experimental | A mucogingival surgery where multiple micro connective tissue graft harvested from the palate are placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronally Advanced Flap combined with a Connective Tissue Graft | Procedure | Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean mid-facial recession coverage (mRC) | Percentage of the exposed tooth root covered after surgical intervention | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Root Coverage (CRC) | Frequency of complete root coverage | up to 1 year |
| Changes of Keratinized Tissue Width (KTW) | Measured as the distance from the muco-gingival-junction to the gingival margin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Carcuac, DDS, PhD | Contact | 556275575 | 00971 | olivier.carcuac@gu.se |
| Jan Derks, DDS, PhD | Contact | 317863124 | 0046 | jan.derks@odontologi.gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Jan Derks, DDS, PhD | Goteborg University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Confident Dubai Palm | Recruiting | Dubai | 0000 | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9118277 | Result | Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available. | |
| 28758301 | Result | Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186. |
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| Coronally Advanced Flap combined with micro Connective Tissue Graft | Procedure | Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with multiple micro connective tissue graft harvested from the palate. |
|
| Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts | Device | The harvested connective tissue graft is divided in multiple micro connective tissue grafts with a scalpel blade before being placed on the recipient site. |
|
| up to 1 year |
| Changes of Gingival Thickness (GT) | Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth | up to 1 year |
| Patient Morbidity | Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') | up to 2 weeks |
| Patient Satisfaction | Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be') | up to 1 year |
| 24640999 | Result | Tonetti MS, Jepsen S; Working Group 2 of the European Workshop on Periodontology. Clinical efficacy of periodontal plastic surgery procedures: consensus report of Group 2 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S36-43. doi: 10.1111/jcpe.12219. |
| 24641000 | Result | Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182. |
| 24641002 | Result | Graziani F, Gennai S, Roldan S, Discepoli N, Buti J, Madianos P, Herrera D. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014 Apr;41 Suppl 15:S63-76. doi: 10.1111/jcpe.12172. |
| 27525096 | Result | Ronco V, Dard M. A novel suturing approach for tissue displacement within minimally invasive periodontal plastic surgery. Clin Case Rep. 2016 Jul 23;4(8):831-7. doi: 10.1002/ccr3.582. eCollection 2016 Aug. |
| 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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