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.: PACTR201803003152150 Date of Approval: 27/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Absorbable collagen wound dressing versus oxidized regenerated cellulose on palatal wound healing
Official scientific title Effect of absorbable collagen wound dressing versus oxidized regenerated cellulose on palatal wound healing (A randomized controlled trial)
Brief summary describing the background and objectives of the trial Free palatal and subepithelial connective tissue grafts have been found to be the most commonly used grafts in periodontal plastic surgeries. The surgical technique of free palatal grafting requires harvesting of soft tissue from the palatal donor site and transplantation to an intraoral recipient one. Post-surgical complications and atypical healing processes have been described in the literature. In order to reduce the morbidity associated with mucogingival surgery, there are several ways to manage the donor site after soft tissue harvesting. Various hemostatic agents have been employed to manage post-operative bleeding at the donor site. The aim of this work is to assess and compare the effects of Absorbable Collagen Wound Dressings and Oxidized Regenerated Cellulose on palatal wound after free palatal graft surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Palatal wound healing after free palatal graft
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2018
Actual trial start date
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
Recruitment status Not yet 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 Permuted block randomisation (block size is variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CollaCote As required, once 14 days Absorbable collagen wound dressing will be placed on donor site 12
Experimental Group Surgicel FibrillarTM As required, once 14 days Oxidized regenerated cellulose will be placed on donor site 12
Control Group PeriAcryl 90 high viscosity As required, once 14 days Adrenaline soaked sterile surgical gauze will be applied and pressure maintained for 5 minutes to control the bleeding, and PeriAcryl®90 high viscosity cyanoacrylate oral adhesive will be used to cover the donor site 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients having at least one site of natural dentition or dental implants that needs to be treated by free palatal graft surgery for indications including progressive recession, planned prosthodontics, mucogingival deformity, or lack of keratinized gingiva. Patients age ranging from 20 to 50 years to avoid possible hormonal effects on soft tissue healing. History of smoking. Patients having any known disease that interferes with periodontal surgery. Patients having dermal or autoimmune disease. Patients having previous adverse reaction to the products (or similar products) used in this study. Pregnant and lactating women. Patients having palatal infection. 20 Year(s) 50 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
No 01/03/2018 IRB, Faculty of Dentistry, University of Alexandria,
Ethics Committee Address
Street address City Postal code Country
Champolion St., Azarita Alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Palatal wound healing after free palatal graft surgery using photo-digital planimetry Day of surgery, 7 days and 14 days postsurgical
Secondary Outcome Pain after harvesting free palatal grafts from palatal donor sites utilizing Visual Analogue Scale (VAS 1 day and 7 days postsurgical
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic at Department of Oral Medicine, Periodontology and Oral Radiology, Faculty of Dentistry, Alexandria University Champolion St., Azarita Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Oral Medicine, Periodontology and Oral Radiology, Faculty of Dentistry, Alexandria University Champolion St., Azarita Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Oral Medicine, Periodontology and Oral Radiology, Faculty of Dentistry, Alexandria University Champolion St., Azarita Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed M Hommos Champolion St., Azarita Alexandria 21526 Egypt
Gehan Sherif Kotry Champolion St., Azarita Alexandria 21526 Egypt
Moustafa Kamel El-Sayed 7 Zaki Badawy st., Stanly Alexandria 21523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Hommos a_hommos@hotmail.com (203)48680866 Champion st.Azarita
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of oral medicines, faculty of dentsistry Alexandria university
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Gihan Korty j_kortry@yahoo.com (203)48680866 Champion st.Azarita
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecture of oral medicines, faculty of dentsistry Alexandria university
REPORTING
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Result URL Hyperlinks Link To Protocol
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Changes to trial information