Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001047611 Date of Approval: 25/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Recession coverage using Amnion Chorion membrane versus SCTG
Official scientific title Clinical Evaluation of Aminion Chorion Membrane in comparison to subepithelial connective tissue graft in gingival recession coverage: A RCT
Brief summary describing the background and objectives of the trial Gingival recession is a common problem which is prevalant in a large population. Gingival recession can cause major functional and esthetic problems. An array of surgical techniques/materials have been utilized to treat gingival recession. The gold standard for root coverage has been SCTG. The aim of the current study is to evaluate the use of amnion chorion versus the gold standard.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Periodontitis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/02/2015
Actual trial start date 25/02/2015
Anticipated date of last follow up 25/02/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer software: Online randomizer Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Subepithelial conncetive tissue graft once at surgey once at surgery natural graft 10 Active-Treatment of Control Group
Experimental Group Amnion chorion membrane once at surgey once at surgery 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Older than 18 years Systematically healthy patients Facial recession Miller I or II Clinical indication for gingival coverage Good Oral hygiene Medically free Miller class III and IV Medically compromised Smokers 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/05/2014 Cairo university- faculty of dentisrtyairo university- faculty of dentisrty
Ethics Committee Address
Street address City Postal code Country
11 El sarya Street1 El sarya Street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Root coverage 1 month 3 month 6 month
Secondary Outcome Gingival biotype 1 month 3 month 6 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of Dentistry 11 El Saraya street El Saraya street El Saraya street El Saraya street cairo University 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Manar Taher Elzanaty 141 villa zayed 2000 6th of october 21611 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Lecturer Hani El Nahass 11 El saraya Street Cairo 112321 Egypt
Assistant Professor Noha Ghallab 11 El saraya Street cairo 112321 Egypt
Professor Mona Shoeib 11 El saraya Street cairo 112321 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Manar Elzanaty manar.elzanaty@dentistry.cu.edu.eg 01001775660 141 villa zayed 2000
City Postal code Country Position/Affiliation
6th of october 21611 Egypt Master degree student
Role Name Email Phone Street address
Scientific Enquiries Hani El Nahass hani.elnahass@dentistry.cu.edu.eg 01002659854 11 El saraya street
City Postal code Country Position/Affiliation
cairo 11562 Egypt Lecturer Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hani El Nahass nahass77@gmail.com 0100265985
City Postal code Country Position/Affiliation
Cairo Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information