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.: PACTR201702001715194 Date of Approval: 14/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The use of acellular dermal matrix with simvastatin gel and bone substitute for hard and soft tissue enhancement around immediate dental implant
Official scientific title The use of acellular dermal matrix with simvastatin gel and bone substitute for hard and soft tissue enhancement around immediate dental implant (Randomized clinical trial)
Brief summary describing the background and objectives of the trial The aim of the study is to compare the effects of the use of either acellular dermal matrix with bone graft alone or acellular dermal matrix with bone graft and simvastatin gel on the soft tissue and crestal bone around immediately inserted dental implants in anterior maxilla
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied badly broken tooth indicated for extraction in the upper anterior region,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 14/07/2015
Actual trial start date 10/12/2015
Anticipated date of last follow up 01/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 21
Actual target sample size (number of participants) 21
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 random computer generated sequence Allocation was determined by sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Immediate dental implant+bone graft +acellular dermal matrix 1 year Acellular dermal matrix and bone graft 7
Experimental Group immediate implant + bone graft+acellular dermal matrix simvastatin gel 1 year Acellular dermal matrix, simvastatin and bone graft 7
Control Group immediate implant + bone graft 1 year the patient will receive one immediate implant and bone graft 7 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Good oral hygiene need for inevitable extraction of single tooth in the maxillary anterior region natural teeth adjacent to the tooth to be extracted will be required to have complete occlusal surface and free from infection Patients welling to follow the study protocol Acute infection at the tooth site Any systemic condition or medication could affect the osseointegration of the dental implants Parafunctional habits Smokers more than 10 cigarettes per day Bleeding problems or anticoagulants Cervicofacial chemotherapy or radiotherapy 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
Yes 21/06/2015 Ethecis committee-Faculty of Dentistry-Ain Shams University
Ethics Committee Address
Street address City Postal code Country
Abbaseya Cairo 1156 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical parameters including:width of keratinized mucosa, thickness of peri implant mucosa, modified plaque index,modified bleeding index,peri implant pocket depth and cone beam computed tomography analysis(CBCT) Clinical parameter: 3 month 9 month 12 month CBCT: 0 month 3 month 12 month
Secondary Outcome Pink esthetic score and white esthetic score 3 month 9 month 12 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patient clinic- Faculty of Dentistry-Ain Shams University Abbaseya Cairo 1156 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Al Gomhoria st Mansoura 35111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Dentistry-Ain Shams University Abbaseya Cairo 1156 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman M Abdulhady Al Gomhoria st Mansoura 35111 Egypt
Khaled Abdel Ghaffar Masr Al gededa-Sant fatema Cairo 11843 Egypt
Waleed Abbas Al tagamo alawal-Al rehab Cairo 11841 Egypt
Mohamed Al Shahat Torail Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Abdulhady eman_abdulhady@yahoo.com 01063060700 Al Gomhoria st
City Postal code Country Position/Affiliation
Mansoura 35111 Egypt Assistant lecturer-Delta University
Role Name Email Phone Street address
Public Enquiries eman abdulhady eman_abdulhady@yahoo.com 00201063060700 Al gomhoria st. Al zahaf building third floor
City Postal code Country Position/Affiliation
Mansoura 35111 Egypt Teacher assistant, Delta University
Role Name Email Phone Street address
Scientific Enquiries Khaled Abdel Ghaffar Ghaffar@link.net 02-26384294 Heliopolis
City Postal code Country Position/Affiliation
Cairo Egypt Dean of Faculty of Dentistry Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Waleed Abbas waleed@asfd.asu.edu.eg 01001418154 Al Tagmoa Al Alawal-Al Rehab
City Postal code Country Position/Affiliation
Cairo 11841 Egypt lecturer of Oral Medicine and Periodontology-Faculty of Dentistry-Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Al Shahat alshahat1960@yahoo.com 01001900391 Torail
City Postal code Country Position/Affiliation
Mansoura Egypt Dean of Faculty of Oral and Dental Medicine-Delta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information