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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.
Gingival recession (GR) is characterized by apical migration of soft tissue margin beyond the cemento-enamel junction (CEJ) or the platform of an implant.
Gingival recession is a common daily finding in every practice. As patients are more concerned with a pleasing smile, root exposure is a growing concern . Moreover, discomfort and inability to perform oral hygiene result from exposed root hypersensitivity. It affects the patient's abilities to maintain adequate plaque control which eventually complicates the situation more. It is advisable to augment tissues and increase keratinized tissue (KT) band to reduce discomfort and obtain an aesthetic smile.
multiple treatment modalities are available for treating gingival recession such as Pedicle flaps (coronally advanced flap (CAF), semilunar flap, laterally sliding flap (lSD), and double papilla flap), Free gingival graft (FGG), Subepithelial connective tissue graft (SCTG), Guided tissue regeneration. Modified coronally advanced tunnel, Vestibular incision subperiosteal tunnel access (VISTA), Pinhole technique (PST).
Size and number of recession defects, KT band, interproximal attachment level, depth vestibule and frenum pull are among factors to determine which procedure is suitable for that type of recession.
For single-type recession (localized or isolated), the use of CAF with SCTG is favorable for both root coverage and KT gain. According to the American Academy of Periodontology regeneration workshop "for Miller class 1 and 2 single-tooth recession defects, SCTG procedures provide the best outcome ". Using CAF combined with SCTG is considered the gold standard treatment for localized recession defects. SCTG improves root coverage, KT gain, and clinical attachment levels. Using SCTG helps stabilize CAF, increase root coverage predictability, and increase soft tissue thickness. CAF with SCTG is a predictable technique to increase root coverage, decrease recession depth, and increase KT width and thickness.
However, obtaining an SCTG has some drawbacks such as the need for a second surgical site to harvest graft increases treatment time and patient morbidity. Bleeding and postoperative discomfort are common after graft harvesting. Another issue is a limited amount of tissue is also a concern in multiple defect cases. Patients' willingness to retreat was affected by previous autogenous grafting.
Recently, the use of placental membranes is introduced as a suitable substitute for SCTG. The human placenta is composed of two membranes inner amniotic and outer chorionic membranes. These membranes secrete anti-inflammatory cytokines and growth factors such as platelet-derived growth factor AA (PDGF-AA) and vascular endothelial growth factor (VEGF). These membranes have anti-inflammatory, angiogenic, antifibrotic, and antimicrobial effects. Furthermore, they have low immunogenicity and improve epithelization. They have been widely used in medicine since the 1910s with increasing clinical applications from wound care and ophthalmology, to plastic surgery.
There is a growing interest in using placental allografts as a substitute for conventional membranes in oral surgical procedures. They are used for root coverage as a substitute for SCTG as these membranes contain different types of collagen, proteoglycans, laminin, and bioactive factors which help in binding gingival epithelial cells to the root surface. They act as reservoirs of stem cells which promote cell differentiation, stimulate healing, and help in revascularization.
So in this study, it is proposed to evaluate Amnion Chorion membrane in the management of gingival recession type 1 in comparison to SCTG.
Aim of the study The primary outcome is to evaluate the effectiveness of the Amnion Chorion membrane (ACM) in the management of gingival recession type 1 (RT1).
The secondary outcome is to compare between ACM and subepithelial connective tissue graft in the treatment of recession defect type 1 (RT1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amnion chorion allograft | Experimental | participants will receive amnion chorion with coronally advanced flap |
|
| Connective tissue graft | Active Comparator | participants will receive connective tissue graft with coronally advanced flap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amnion Chorion membrane | Biological | it is a placental allograft. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recession Width | it is measured at the widest point from the mesial gingival margin to the distal gingival margin in millimeters | changes in millimeters from base line to follow up after 6 months |
| the height of keratinized gingiva |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Khalil, professor | Minia University | Study Chair |
| Aya Mohammed, Lecturer | Minia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of dentistry, Minia University | Minya | Other | 61111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28893718 | Background | 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. | |
| 21507033 | Background | 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. |
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All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
Data are available indefinitely at (Link to be included).
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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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two groups Group 1 contains 16 patients and will be treated by CAF and SCTG. Group 2 also contains 16 patients and will be treated by CAF and ACM (bioxclude, snoasis medical, Denver, Co.USA).
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| connective tissue graft |
| Procedure |
it is an autograft |
|
it is measured in millimeters as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction location determined using a visual method.
| changes in millimeters from base line to follow up after 6 months |
| Probing pocket depth | it is measured as the distance from the gingival margin to base of pocket. | changes in millimeters from base line to follow up after 6 months |
| percentage of root coverage | it will be calculated as [pre-operative gingival recession depth - post-operative recession depth]/ [preoperative recession depth] * 100% | changes in percentile from base line to follow up after 6 months |
| 18584934 | Background | 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. |
| 21859324 | Background | 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. |
| 30277568 | Background | 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. |
| 25644302 | Background | 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. |
| 17309597 | Background | 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. |
| 33354857 | Background | 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. |
| 34024328 | Background | 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. |
| 28338039 | Background | 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. |
| 36578557 | Background | 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. |
| 26561997 | Background | 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. |
| 32851531 | Background | 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. |
| 29504166 | Background | 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. |
| 21158897 | Background | 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. |
| 29504173 | Background | 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. |
| 32946124 | Background | 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. |
| D055093 |
| Periodontal Atrophy |