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

May 23, 2025 updated by: Mina gerges, Minia University

The Efficacy of Amnion Chorion Allograft in Management of Type 1 Gingival Recession. (Randomized Clinical Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Other
      • Minya, Other, Egypt, 61111
        • Faculty of dentistry, Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Selected patients of both sexes are 25-45 years old.
  2. Patients are systemically healthy based on the questionnaire dental modification of the Cornell index.
  3. 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).
  4. Buccal recession defects are classified RT1 according to Cairo's classification (2011).
  5. Clinical indication and/or patient request for recession coverage.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amnion chorion allograft
participants will receive amnion chorion with coronally advanced flap
Biological: Amnion Chorion membrane
it is a placental allograft.
Active Comparator: Connective tissue graft
participants will receive connective tissue graft with coronally advanced flap
Procedure: connective tissue graft
it is an autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recession depth
Time Frame: changes in millimeters from base line to follow up after 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession Width
Time Frame: changes in millimeters from base line to follow up after 6 months
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
Time Frame: changes in millimeters from base line to follow up after 6 months
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
Time Frame: changes in millimeters from base line to follow up after 6 months
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
Time Frame: changes in percentile from base line to follow up after 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Study Chair: Ahmed Khalil, professor, Minia university
  • Study Director: Aya Mohammed, Lecturer, Minia university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

March 22, 2025

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Data are available indefinitely at (Link to be included).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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