The Efficacy of Amnion Chorion Allograft in Management of Gingival Recession.

NCT06508476 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 857
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Amnion chorion allograft

EXPERIMENTAL

participants will receive amnion chorion with coronally advanced flap

Biological: Amnion Chorion membrane

Connective tissue graft

ACTIVE COMPARATOR

participants will receive connective tissue graft with coronally advanced flap

Procedure: connective tissue graft

Interventions

Amnion Chorion membrane BIOLOGICAL

it is a placental allograft.

Amnion chorion allograft

connective tissue graft PROCEDURE

it is an autograft

Connective tissue graft

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Selected patients of both sexes are 25-45 years old.
• Patients are systemically healthy based on the questionnaire dental modification of the Cornell index.
• O'Leary index (1972) is less than 10% (the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation).
• Buccal recession defects are classified RT1 according to Cairo's classification (2011).
• Clinical indication and/or patient request for recession coverage.

You may not qualify if:

• RT2 and RT3 recession defects.
• Pregnant female.
• Smokers.
• Patients with special needs or with any mental problems.
• All patients are using any kind of medication that could interfere with the healing of periodontal tissues. Such as chemotherapy and radiotherapy.
• Teeth with root carious lesions.
• Rotated and extruded teeth.
• Patients underwent any prior periodontal surgery in the relevant region.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

faculty of dentistry, Minia University

Minya, Other, 61111, Egypt

Location

Related Publications (17)

• 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.

  PMID: 28893718 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.

  PMID: 21507033 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.

  PMID: 18584934 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.

  PMID: 21859324 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.

  PMID: 30277568 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.

  PMID: 25644302 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.

  PMID: 17309597 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.

  PMID: 33354857 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.

  PMID: 34024328 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.

  PMID: 28338039 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.

  PMID: 36578557 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.

  PMID: 26561997 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.

  PMID: 32851531 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.

  PMID: 29504166 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.

  PMID: 21158897 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.

  PMID: 29504173 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.

  PMID: 32946124 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Ahmed Khalil, professor

  Minia University

  STUDY CHAIR

• Aya Mohammed, Lecturer

  Minia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 18, 2024
• Study Start: August 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 22, 2025
• Last Updated: May 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data are available indefinitely at (Link to be included).

Locations

EG (1)