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The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).
The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coronally advanced flap with amnion chorion membrane | Experimental | coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier. |
|
| subepithelial connective tissue graft | Active Comparator | coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amnion chorion allograft membrane | Biological | Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| recession depth | It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage. | Change in mm from baseline before surgical procedure to follow up at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Recession Width | It is measured as the distance from mesial and distal papillae along cemento-enamel junction. | Change in mm from baseline before surgical procedure to follow up at 6 months. |
| Width of keratinized gingiva |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Shoeib, MD | Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. | Study Chair |
| Hani El-Nahas, MD | Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. | Study Director |
| Manar El-Zanaty, Msc. | manarzanaty@hotmail.com | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22639845 | Result | Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28. | |
| 24641000 |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| coronally advanced flap with the subepithelial connective tissue graft | Procedure | coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate |
|
|
It is measured from the mucogingival junction to the free gingival margin.
| Change in mm from baseline before surgical procedure to follow up at 6 months. |
| Probing pocket depth | It is measuring the distance from the base of pocket to the gingival margin. | Change in mm from baseline before surgical procedure to follow up at 6 months. |
| Clinical attachment level | It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction. | Change in mm from baseline before surgical procedure to follow up at 6 months. |
| Tissue Biotype | It is measured by penetrating the gingiva with the periodontal probe down to bone after giving local anesthesia to measure the thickness of gingival tissues | Change in mm from baseline before surgical procedure to follow up at 6 months. |
| root coverage esthetic score | The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color | score taken after completion of the study at 6 months |
| Patient reported outcomes | Patients were given certain questions regarding not regretting to perform the surgery, root hypersensitivity and aesthetic satisfaction to be answered at the 6 month follow-up for assessing their satisfaction with the whole procedure. | taken after completion of the study at 6 months |
| 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. |
| 25644302 | Result | Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674. |
| 26501023 | Result | Chakraborthy S, Sambashivaiah S, Kulal R, Bilchodmath S. Amnion and Chorion Allografts in Combination with Coronally Advanced Flap in the Treatment of Gingival Recession: A Clinical Study. J Clin Diagn Res. 2015 Sep;9(9):ZC98-ZC101. doi: 10.7860/JCDR/2015/12971.6572. Epub 2015 Sep 1. |
| 17309597 | Result | de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x. |
| 24364174 | Result | Ghahroudi AA, Khorsand A, Rokn AR, Sabounchi SS, Shayesteh YS, Soolari A. Comparison of amnion allograft with connective tissue graft for root coverage procedures: a double-blind, randomized, controlled clinical trial. J Int Acad Periodontol. 2013 Oct;15(4):101-12. |
| D055093 |
| Periodontal Atrophy |