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.: PACTR201501000945275 Date of Approval: 21/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Maxillary ridge augmentation
Official scientific title Evaluation of the Effect of Platelet-Rich Fibrin on the Surface Resorption of Autogenous Block Grafts in Anterior Maxillary Deficient Ridges: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Objective: The objective of this study is to evaluate the surface resorption, ridge width and bone vitality of autogenous block grafts (from buccal shelf or chin) covered with PRF membrane versus that of autogenous block grafts that will be placed solely, which in turn would affect the feasibility of post-augmentation implant placement and consequently would benefit the implant patients. P:Population: Patients with deficient anterior maxillary ridges each receiving ridge augmentation procedure I: Intervention: Group A: Autogenous Block grafts + PRF membrane C:Comparator: Group B: Autogenous Block grafts O:Outcome: ¿ Primary outcome: Surface resorption of autogenous block grafts ¿ Secondary outcome: Ridge width and bone vitality Formulated question: Can the use of PRF membrane reduce the surface resorption of autogenous block grafts for augmentation of anterior maxillary deficient ridges, thus increasing the feasibility of post augmentation implant placement? Under Local anaesthesia, Group A patients will receive anterior maxillary ridge augmentation procedure using autogenous block graft from buccal shelf or chin and this graft will be covered by platelet-rich fibrin membrane. On the other hand, Group B patients will recieve maxillary ridge augmentation procedure using autogenous block graft that will be placed solely. Ridge width will be measured pre-operatively (T0), immediately post-operatively (T1), and 4 months post-operatively (T2) clinically and radiographically. Graft resorption will be measured by subtracting T1-T2 clinically and radiographically Gain in ridge width will be measured by subtracting T2-T0 Bone vitality will be assessed histologically by taking bone core biopsy at re-entry at the proposed implant sites immediately before implant placement.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Patients with deficient anterior maxillary ridges each receiving ridge augmentation procedure
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 22/11/2014
Actual trial start date
Anticipated date of last follow up 21/06/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants) 16
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 generated randomization (random.org) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised computer generated randomization (random.org) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 4 months Autogenous bone block grafts + Platelet-rich fibrin membrane 8 Active-Treatment of Control Group
Control Group Group B 4 months Autogenous bone block grafts 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Patient age: between 20-45 years old. 2-Patients with no systemic diseases. 3-Partially edentulous patients with missing teeth in the anterior maxillary region. 4-Patients should have anterior maxillary ridge width (< 4mm). 5-Absence of any pathological conditions in the anterior maxilla (recipient site). 6-Availability of bone in the mandibular ramus or symphysis (donor site). 1-Patients with poor oral hygiene. 2-Patients showing no or poor compliance with non-surgical phase of treatment. 3-Pregnant females. 4-Smokers. 5-Previous head and neck radiation therapy. 6-Patients with an allergy to any material or medication that will be used in the study. 7-Severe psychological problems. 8-Habits like bruxism and clenching. 20 Year(s) 45 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 09/06/2014 The Ethics Committee of Scientific Research - faculty of oral and dental medicine - Cairo University.
Ethics Committee Address
Street address City Postal code Country
Faculty of Oral and Dental Medicine - Cairo University Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Bone vitality T2: 4 months post-operatively
Primary Outcome Graft resorption T1: immediate post-operatively T2: 4 months post-operatively Graft resorption T1-T2
Secondary Outcome Gain in Ridge Width T0: pre-operatively T1: immediate post-operatively T2: 4 months post-operatively Gain in ridge width = T2-T0
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Oral Medicine and Periodontology department ¿ Faculty of Oral and Dental Medicine - Cairo University El Manial St. - Giza - EGYPT Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self-funding 6C Nojoom El-Sefarat Building - Apartment 53 - 5th Floor - Makkah Street - El-Sefarat District - Nasr City Cairo 11471 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine-Cairo University El Manial St. - Giza - EGYPT Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Mona Shoeib 121 el mekarief st. - Nasr City Cairo 11391 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Mohamed dr.omaragab123@gmail.com +201227013601 Apartment 53 5th Floor 6C Nojoom El-Sefarat Building Makkah Street El-Sefarat District
City Postal code Country Position/Affiliation
Nasr City- Cairo 11471 Egypt Faculty of Dentistry - Fayoum University
Role Name Email Phone Street address
Public Enquiries Omar Mohamed dr.omaragab123@gmail.com +201227013601 Apartment 53 5th Floor 6C Nojoom El-Sefarat Building Makkah Street El-Sefarat District
City Postal code Country Position/Affiliation
Cairo 11471 Egypt Faculty of Dentistry - Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Mona Shoeib monashoeib@perio.org +201223102216 121 Elmekarief st.-Nasr City
City Postal code Country Position/Affiliation
Cairo 11391 Egypt Faculty of Oral and Dental Medicine - Cairo University
Role Name Email Phone Street address
Scientific Enquiries Omar Mohamed dr.omaragab123@gmail.com +201227013601
City Postal code Country Position/Affiliation
Cairo 11471 Egypt Faculty of Dentistry - Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Karim El-Sayed karimf78@hotmail.com +201005444050
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of Oral and Dental Medicine - Cairo University
REPORTING
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