NCT06508476|CompletedPhase 4DMCFDA Drug
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Sponsor study identifier
interventional
28
1 country
1
Study Start
August 1, 2024
Actual (reported)Primary Completion
January 31, 2025
Actual (reported)Study Completion
March 22, 2025
Actual (reported)the main goal of this clinical trial is to test the efficacy of amnion Chorion allograft in managing gingival recession. The main questions it aims to answer are: Is it effective in treating gingival recession, and how it compares to connective tissue graft.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 22, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 3, 2024
Actual (reported)July 18, 2024
Actual (reported)August 1, 2024
Actual (reported)January 31, 2025
Actual (reported)March 22, 2025
Actual (reported)recession depth
recession depth is measured from CEJ to the gingival margin in millimeters.
changes in millimeters from base line to follow up after 6 months
Recession Width
changes in millimeters from base line to follow up after 6 months
the height of keratinized gingiva
changes in millimeters from base line to follow up after 6 months
Probing pocket depth
changes in millimeters from base line to follow up after 6 months
percentage of root coverage
changes in percentile from base line to follow up after 6 months
participants will receive amnion chorion with coronally advanced flap
participants will receive connective tissue graft with coronally advanced flap
it is a placental allograft.
it is an autograft
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
faculty of dentistry, Minia University
Minya, Other, 61111, Egypt
Amine K, El Amrani Y, Chemlali S, Kissa J. Alternatives to connective tissue graft in the treatment of localized gingival recessions: A systematic review. J Stomatol Oral Maxillofac Surg. 2018 Feb;119(1):25-32. doi: 10.1016/j.jormas.2017.09.005. Epub 2017 Sep 9.
Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.
Ahmed Khalil, professor
Minia University
Aya Mohammed, Lecturer
Minia University
28 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2024
First Posted
July 18, 2024
Study Start
Contact the study team to confirm eligibility.
Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
Chambrone L, Pannuti CM, Tu YK, Chambrone LA. Evidence-based periodontal plastic surgery. II. An individual data meta-analysis for evaluating factors in achieving complete root coverage. J Periodontol. 2012 Apr;83(4):477-90. doi: 10.1902/jop.2011.110382. Epub 2011 Aug 22.
Chambrone L, Salinas Ortega MA, Sukekava F, Rotundo R, Kalemaj Z, Buti J, Pini Prato GP. Root coverage procedures for treating localised and multiple recession-type defects. Cochrane Database Syst Rev. 2018 Oct 2;10(10):CD007161. doi: 10.1002/14651858.CD007161.pub3.
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.
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.
Gulameabasse S, Gindraux F, Catros S, Fricain JC, Fenelon M. Chorion and amnion/chorion membranes in oral and periodontal surgery: A systematic review. J Biomed Mater Res B Appl Biomater. 2021 Aug;109(8):1216-1229. doi: 10.1002/jbm.b.34783. Epub 2020 Dec 22.
Imber JC, Kasaj A. Treatment of Gingival Recession: When and How? Int Dent J. 2021 Jun;71(3):178-187. doi: 10.1111/idj.12617. Epub 2021 Jan 29.
Madeley E, Duane B. Coronally advanced flap combined with connective tissue graft; treatment of choice for root coverage following recession? Evid Based Dent. 2017 Mar;18(1):6-7. doi: 10.1038/sj.ebd.6401215.
Maity S, Priyadharshini V. Comparison of chorion allograft and subepithelial connective tissue autograft in the treatment of gingival recession- A randomized controlled clinical trial. J Oral Biol Craniofac Res. 2023 Mar-Apr;13(2):104-110. doi: 10.1016/j.jobcr.2022.12.002. Epub 2022 Dec 5.
Moraschini V, Barboza Edos S. Use of Platelet-Rich Fibrin Membrane in the Treatment of Gingival Recession: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Mar;87(3):281-90. doi: 10.1902/jop.2015.150420. Epub 2015 Nov 12.
Moraschini V, Calasans-Maia MD, Dias AT, de Carvalho Formiga M, Sartoretto SC, Sculean A, Shibli JA. Effectiveness of connective tissue graft substitutes for the treatment of gingival recessions compared with coronally advanced flap: a network meta-analysis. Clin Oral Investig. 2020 Oct;24(10):3395-3406. doi: 10.1007/s00784-020-03547-3. Epub 2020 Aug 26.
Mounssif I, Stefanini M, Mazzotti C, Marzadori M, Sangiorgi M, Zucchelli G. Esthetic evaluation and patient-centered outcomes in root-coverage procedures. Periodontol 2000. 2018 Jun;77(1):19-53. doi: 10.1111/prd.12216. Epub 2018 Mar 4.
Pini-Prato G. The Miller classification of gingival recession: limits and drawbacks. J Clin Periodontol. 2011 Mar;38(3):243-5. doi: 10.1111/j.1600-051X.2010.01655.x. Epub 2010 Dec 15. No abstract available.
Stefanini M, Marzadori M, Aroca S, Felice P, Sangiorgi M, Zucchelli G. Decision making in root-coverage procedures for the esthetic outcome. Periodontol 2000. 2018 Jun;77(1):54-64. doi: 10.1111/prd.12205. Epub 2018 Mar 4.
Tavelli L, Barootchi S, Di Gianfilippo R, Kneifati A, Majzoub J, Stefanini M, Zucchelli G, Wang HL. Patient experience of autogenous soft tissue grafting has an implication for future treatment: A 10- to 15-year cross-sectional study. J Periodontol. 2021 May;92(5):637-647. doi: 10.1002/JPER.20-0350. Epub 2020 Oct 3.
August 1, 2024
Actual (reported)Primary Completion
January 31, 2025
Actual (reported)Study Completion
March 22, 2025
Actual (reported)Last Updated
May 29, 2025
Record last verified: 2024-07
All of the individual participant data collected during the trial, after deidentification.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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