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Gingival RecessionNCT02656732

Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage

A study testing amnion chorion allograft membrane and coronally advanced flap with the subepithelial connective tissue graft in people with Gingival Recession, run by Cairo University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 20 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
amnion chorion allograft membrane and coronally advanced flap with the subepithelial connective tissue graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jun 2014to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects aged between 18 - 60 years old.
  • Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification.
  • Subjects able to tolerate surgical periodontal procedures.
  • Accepts the 6 months follow-up period.

Who cannot join

  • Current and former smokers.
  • Pregnant females.
  • Subjects received any periodontal therapy for a minimum of 6 months prior to the study.
  • Subjects taking drugs known to interfere with wound healing.
  • Subjects with unacceptable oral hygiene with plaque index >2.
  • Teeth with non-carious cervical lesions, cervical caries and malalignment.

About this study

Official title: Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.

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).

Read the detailed description

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.

Being tested
amnion chorion allograft membrane, coronally advanced flap with the subepithelial connective tissue graft
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • amnion chorion allograft membraneBiological

    Also called BioXclude™,Snoasis Medical products, USA.

    Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.

  • coronally advanced flap with the subepithelial connective tissue graftProcedure or surgery

    Also called autogenous connective tissue graft

    coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate

Study groups in NCT02656732
Study groupRoleWhat they receive
coronally advanced flap with amnion chorion membraneExperimentalcoronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier.
Receives: Biological: amnion chorion allograft membrane
subepithelial connective tissue graftActive comparatorcoronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.
Receives: Procedure: coronally advanced flap with the subepithelial connective tissue graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recession depth

    It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.

    Measured: Change in mm from baseline before surgical procedure to follow up at 6 months.

Secondary outcomes (7)

  1. Recession Width

    It is measured as the distance from mesial and distal papillae along cemento-enamel junction.

    Measured: Change in mm from baseline before surgical procedure to follow up at 6 months.

  2. Width of keratinized gingiva

    It is measured from the mucogingival junction to the free gingival margin.

    Measured: Change in mm from baseline before surgical procedure to follow up at 6 months.

  3. Probing pocket depth

    It is measuring the distance from the base of pocket to the gingival margin.

    Measured: Change in mm from baseline before surgical procedure to follow up at 6 months.

  4. Clinical attachment level

    It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction.

    Measured: Change in mm from baseline before surgical procedure to follow up at 6 months.

  5. 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

    Measured: Change in mm from baseline before surgical procedure to follow up at 6 months.

  6. 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

    Measured: score taken after completion of the study at 6 months

  7. 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.

    Measured: taken after completion of the study at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionApr 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02656732
Sponsor's protocol ID
AC_SCTG
Status last verified
Apr 2017
First submitted
13 Jan 2016
Last updated
24 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22639845

  • 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.

    PubMed 24641000

  • 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.

    PubMed 25644302

  • 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.

    PubMed 26501023

  • 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.

    PubMed 17309597

  • 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.

    PubMed 24364174

Questions about this trial

What is this clinical trial studying?

A study testing amnion chorion allograft membrane and coronally advanced flap with the subepithelial connective tissue graft in people with Gingival Recession, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recession depth (time frame: Change in mm from baseline before surgical procedure to follow up at 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02656732, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.

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