]>
IRCT20210330050791N1 IRCT 2021-07-21 Shiraz University of Medical Sciences Assesment of the Effectiveness of Amniotic Membrane Seeded by Whartons' Jelly Stem Cells plus Coronally Advanced Flap for the Treatment of Gingival Recession Clinical comparison of coronally advanced flap plus amniotic membrane seeded with whartons' jelly mesenchymal stem cells and subepithelial connective tissue graft in the treatment of single Miller's class I and II gingival recessions 2021-04-24 anticipated 20 Complete https://irct.ir/trial/55486 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization(block size=2) is computer-generated by the study statistician and the treatment assignments sequentially will be delivered to the operating surgeon for implementation. All pre- and postoperative clinical measurements will be made by a single, masked examiner who is not the operating surgeon and is blinded to the study design and grouping, Blinding description: After explaining the study and tratment procedures for patients completely and acceptance for participating in the study the allocating group for each one is concealed. All pre- and postoperative clinical measurements will be made by a single, masked examiner who is not the operating surgeon and is blinded to the study design and grouping . Finally the study statistician will analyse the data without knowing what treatment is used for each group. N/A Gingival Recession. Intervention 1: Intervention group: coronally advanced flap plus amniotic membrane seeded with whartons jelly mesenchymal stem for root coverage of single Millers class I and II gingival recessions. Intervention 2: Control group: coronally advanced flap plus connective tissue graft for root coverage of single Millers class I and II gingival recessions. Yes - There is a plan to make this available What will be shared: All patient information that is effective in the result of the study and variables that are recorded before and after surgery will be published as part of the study. When: Start of the access from the time the results are published To whom: All people who are eager to further research on this issue Conditions: In order to use the information in review articles and further research and study on this subject, the information will be provided to the applicant after authentication. Where to obtain: Contact Dr. Maryam Sabet as the researcher and author of this research via email address: mahsasabet86@yahoo.com How to obtain: After proving the identity of the applicant and explaining the reason for the need for data, the information will be emailed to him in PDF format. Comments:
public Maryam Sabet
No. 4, 2nd floor, 2019 Building, No. 6 Alley, Khalili Ave.
Shiraz Iran (Islamic Republic of) 7193654478 +98 71 3830 2141 mahsasabet86@yahoo.com Shiraz University of Medical Sciences scientific Maryam Sabet
No. 4, 2nd floor, 2019 Building, No. 6 Alley, Khalili Ave.
Shiraz Iran (Islamic Republic of) 7193654478 +98 71 3830 2141 mahsasabet86@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 or more Patients who have read, understood, and signed an informed consent form Patients who have been able and willing to follow study procedures and instructions Patients who have at least one tooth with buccal Miller class I or II recession type defects Recessions with ≥ ۲ mm depth and ≥ ۲mm width in premolar, canine or incisor area, with probing depths ≤۴ mm and ≥ ۲ mm keratinized tissue Treating only one tooth at each side as a test or control tooth in case of adjacent teeth with recession defects 18 years no limit Both ُubjects who are participating in other clinical trials Subjects who have a history of cancer or human immunodeficiency virus Subjects who have an uncontrolled systemic disease with compromised healing potential (such as diabetes mellitus with a recent HbA۱c > ۷%) Using medications known to cause gingival enlargement and anticoagulants with International Normalized Ratio (INR) > ۲.۵ and taking herapeutic doses of medications known to affect bone metabolism Those who fail to maintain good plaque control Teeth with extremely prominent root surfaces Teeth with Class V restorations extending to root surfaces Subjects who have any systemic acute infections in the areas intended for surgery Female subjects who are pregnant or lactating History of surgical periodontal treatment of the involved site Severe tooth malposition or open contacts Current or planned orthodontic treatment during the ۳-month course of the study Molars; teeth with axial mobility; teeth with interproximal loss of attachment; teeth with crowns or veneers causing an undetectable CEJ Patients with a frenum and/or muscle attachment encroaching on marginal gingiva in the first ۶ weeks after frenectomy procedure History of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking within the previous ۶ months K06.0 Gingival recession Treatment - Surgery Treatment - Surgery Intervention group: coronally advanced flap plus amniotic membrane seeded with whartons jelly mesenchymal stem for root coverage of single Millers class I and II gingival recessions Control group: coronally advanced flap plus connective tissue graft for root coverage of single Millers class I and II gingival recessions Recession depth: distance between CEJ and gingival zenith. Timepoint: at start point and 3 months after surgery. Method of measurement: measured with standard periodontal probe (williams probe). Recession width: the width of the recession defect at the level of CEJ. Timepoint: at start point and 3 months after surgery. Method of measurement: measured with standard periodontal probe (williams probe). Clinical attachment loss: the length from the CEJ to the depth of the pocket base. Timepoint: at start point and 3 months after surgery. Method of measurement: measured with standard periodontal probe(williams probe) in mesial,distal and buccal surfaces of tooth. Probing depth: distance from gingival margin to the base of the sulcus or pocket. Timepoint: at start point and 3 months after surgery. Method of measurement: measured with standard periodontal probe(williams probe) at mesial, distal and buccal side of the tooth. Keratinized tissue height: height of keratinized tissue from the free gingival margin to the mucogingival junction. Timepoint: at start point and 3 months after surgery. Method of measurement: measured with standard periodontal probe(williams probe). Keratinized tissue thickness: the thickness of keratinized tissue measured from outer surface of buccal keratinized tissue to the buccal surface of the tooth. Timepoint: at start point and 3 months after surgery. Method of measurement: determined ۱.۵mm apically to the gingival margin on the central point of the buccal surface, using a number ۱۵ endodontic file with an endodontic stop. O´Leary plaque score: The presence of supra gingival plaque on all four tooth surfaces. Timepoint: at base time and 3 months after surgery. Method of measurement: The plaque is disclosed. The presence or absence of plaque is recorded in a simple chart. The plaque incidence in the oral cavity is expressed as an exact percentage. Gingival index: The gingival index records gingival inflammation on facial, lingual, mesial and distal sites if teeth. Timepoint: at base time and 3 months after surgery. Method of measurement: Grade0: Normal gingiva Geade1: Mild inflammation Grade2: Moderate inflammation Grade3: Severe inflammation. The subject’s perception of pain/discomfort: The amount of pain/discomfort that the patients experience because of exposed root surfaces and shows the amount of root hypersensitivity. Timepoint: at base time and 3 months after surgery. Method of measurement: visual analogue scale (۰: no pain/discomfort ۱۰:severe pain/discomfort). Shiraz University of Medical Sciences Approved 2021-06-13 Research Ethics committee of Shiraz University of Medical Sciences No. 303, Navvab safavi 3/2 Alley, Baghe hoz Blvd Shiraz Fars Iran (Islamic Republic of)