Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
amnion chorion allograft membrane
coronally advanced flap with the subepithelial connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
coronally advanced flap with amnion chorion membrane
subepithelial connective tissue graft
Arm Description
coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier.
coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.
Outcomes
Primary Outcome Measures
recession depth
It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.
Secondary Outcome Measures
Recession Width
It is measured as the distance from mesial and distal papillae along cemento-enamel junction.
Width of keratinized gingiva
It is measured from the mucogingival junction to the free gingival margin.
Probing pocket depth
It is measuring the distance from the base of pocket to the gingival margin.
Clinical attachment level
It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction.
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02656732
Brief Title
Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage
Official Title
Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
coronally advanced flap with amnion chorion membrane
Arm Type
Experimental
Arm Description
coronally advanced flap was reflected and amnion chorion allograft membrane was placed under the flap as a guided tissue regeneration barrier.
Arm Title
subepithelial connective tissue graft
Arm Type
Active Comparator
Arm Description
coronally advanced flap was reflected and subepithelial connective tissue graft was harvested from the palate and placed under the flap.
Intervention Type
Biological
Intervention Name(s)
amnion chorion allograft membrane
Other Intervention Name(s)
BioXclude™,Snoasis Medical products, USA.
Intervention Description
Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.
Intervention Type
Procedure
Intervention Name(s)
coronally advanced flap with the subepithelial connective tissue graft
Other Intervention Name(s)
autogenous connective tissue graft
Intervention Description
coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate
Primary Outcome Measure Information:
Title
recession depth
Description
It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.
Time Frame
Change in mm from baseline before surgical procedure to follow up at 6 months.
Secondary Outcome Measure Information:
Title
Recession Width
Description
It is measured as the distance from mesial and distal papillae along cemento-enamel junction.
Time Frame
Change in mm from baseline before surgical procedure to follow up at 6 months.
Title
Width of keratinized gingiva
Description
It is measured from the mucogingival junction to the free gingival margin.
Time Frame
Change in mm from baseline before surgical procedure to follow up at 6 months.
Title
Probing pocket depth
Description
It is measuring the distance from the base of pocket to the gingival margin.
Time Frame
Change in mm from baseline before surgical procedure to follow up at 6 months.
Title
Clinical attachment level
Description
It is measuring the distance from the apical end of periodontal probe to cemento-enamel junction.
Time Frame
Change in mm from baseline before surgical procedure to follow up at 6 months.
Title
Tissue Biotype
Description
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
Time Frame
Change in mm from baseline before surgical procedure to follow up at 6 months.
Title
root coverage esthetic score
Description
The clinical esthetic evaluation was performed without magnification to evaluate gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color
Time Frame
score taken after completion of the study at 6 months
Title
Patient reported outcomes
Description
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.
Time Frame
taken after completion of the study at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Shoeib, MD
Organizational Affiliation
Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hani El-Nahas, MD
Organizational Affiliation
Associate Professor of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manar El-Zanaty, Msc.
Organizational Affiliation
manarzanaty@hotmail.com
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22639845
Citation
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.
Results Reference
result
PubMed Identifier
24641000
Citation
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.
Results Reference
result
PubMed Identifier
25644302
Citation
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.
Results Reference
result
PubMed Identifier
26501023
Citation
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.
Results Reference
result
PubMed Identifier
17309597
Citation
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.
Results Reference
result
PubMed Identifier
24364174
Citation
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.
Results Reference
result
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Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage
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