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.: PACTR201509000914264 Date of Approval: 23/10/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of Platelet-Rich Fibrin versus Collagen membranes in the treatment of dehiscence defects around dental implants. A Randomized Clinical Tria
Official scientific title Evaluation of Platelet-Rich Fibrin versus Collagen membranes in the treatment of dehiscence defects around dental implants. A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial The Management of dehiscence defects around dental implants has been intensively appraised and reviewed in literature. Treatment of dehiscence defects was focused on applying guided bone regeneration (GBR) procedures using various types of grafting materials with or without barrier membranes (De Boever & De Boever, 2005). In the literature, the application of platelet concentrates in conjunction with bone grafts and dental implants were mainly limited to sinus-lift procedures (Choukroun et al., 2006, Kfir et al., 2009). The present study aims to discuss whether PRF in conjunction with bone graft will improve bone healing in dehiscence defects around dental implants in terms of thickness and amount of bone fill.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PRF
Disease(s) or condition(s) being studied the is no disease entity involved in the study
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2014
Actual trial start date 02/11/2014
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date 30/09/2016
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 coin tossing Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Collagen membrane once six monthes application of collagen membrane and a xenograft over the dehisced dental implant 10 Active-Treatment of Control Group
Experimental Group Platelet Rich Fibrin (PRF) once 6 months application of PRF and a xenograft over the dehisced dental implant 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Adult partially edentulous patients. 2.Healed alveolar ridge with buccolingual width < 6mm. 3.Adequate inter-arch space. 1.Non-human subjects. 2.Non-submerged one-stage implantation. 3.Patients requiring immediate post-extraction implantation. 4.Studies applying bone graft alone to treat the dehiscence defect without a membrane and vice-versa. 5.Any systemic condition that may interfere with wound healing. 6.Pregnant females. 7.Smokers. 8.Incompliant patients or patients with poor oral hygiene. 18 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
Yes 15/12/2014 Ethical Committee of the Faculty of Oral and Dental Medicine
Ethics Committee Address
Street address City Postal code Country
11, Sraya Al Manial Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of bone fill of the dehiscence defect on re-entry six monthes post surgery
Secondary Outcome Thickness and quality of soft tissues 6 months post-surgery
Secondary Outcome Pain and discomfort experienced by the patient post-surgically 2 weeks postsurgically
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Oral and Dental Medicine 11, Saraya Al Manial St. Cairo Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 60, Domiat St. Giza 12654 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No sponser Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmad Reda 11, Saraya Al Manial St. Cairo Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Zahran dramrzahran@hotmail.com 00201223101977 10, Al Nakhil st. from Batal Ahmad Abdelaziz st, Giza
City Postal code Country Position/Affiliation
Egypt
Role Name Email Phone Street address
Principal Investigator Amr Zahran dramrzahran@hotmail.com 00201223101977 10, Al Nakhil st. from Batal Ahmad Abdelaziz st, Giza
City Postal code Country Position/Affiliation
Giza Egypt
Role Name Email Phone Street address
Public Enquiries Hassan Ahmad hassan.ahmed@dentistry.cu.edu.eg 00201015009014 11 Saraya Al Manial st. Cairo
City Postal code Country Position/Affiliation
Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Eman Desouky dr.emandesouky@yahoo.com 00201004143272 11 Saraya Al Manial st. Cairo
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