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.: PACTR201312000640136 Date of Approval: 07/09/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Bone Morphogenetic Protein (BMP) on Implant Stability and Bone Height in Immediately Loaded Implant Supported Mandibular Over denture
Official scientific title The Effect of Bone Morphogenetic Protein (BMP) on Implant Stability and Bone Height in Immediately Loaded Implant Supported Mandibular Over denture (Randomized Clinical Trial)
Brief summary describing the background and objectives of the trial The implants can be rendered osteoinductive by the introduction of an osteogenic agent, such as bone morphogenetic protein-2(BMP-2).There for radiographic investigation of osseointegration around the implant surface in conventional titanium dental implant coated with ready-made bone morphogenetic protein (BMP) and conventional titanium dental implant surface has been of growing interest The aim this study is to compare and evaluate the implant stability and bone height (Osseointegration) of two different surfaces topography in immediately loaded implant supported mandibular overdentures 1- Conventional titanium dental implant coated with ready-made Bone morphogenetic protein (BMP). 2- Conventional titanium dental implant surface
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mandibular implant denture,Musculoskeletal Diseases,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2013
Actual trial start date 01/10/2013
Anticipated date of last follow up 01/10/2015
Actual Last follow-up date 01/10/2015
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants) 10
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 Allocation ratio (1:1)Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Allocation ratio (1:1)Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional titanium dental implant coated with ready-made Bone morphogenetic protein (BMP 2 implants/patients 1 year Conventional titanium dental implant coated with ready-made Bone morphogenetic protein (BMP 5 Active-Treatment of Control Group
Control Group Conventional titanium dental implant 2 implants/patients 1 year Conventional titanium dental implant 5 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patient with completely edentulous upper and lower arch with normal maxillomandibular relationship (angle's class I ridge ) - Patient's age ranging from forty to sixty years old. - Patients should have be medically free. - The remaining residual ridge had enough height, width and free from any signs of ulceration or inflammation. - Patient should have adequate interarch distance >10mm. - Patient should be with good oral hygiene - Patients are non- smokers. - All patients had been edentulous from at least 1 year before implant placement - Partially edentulous patient. - Patients with TMJ disorders, hemi-mandiblectomy or total maxilloectomy . - Patients administrated systemic drugs which may affect the bone healing or osseointegration around the dental implants. - Patients with any systemic disease that may interfere with dental implants placement and/or Osseo integration e.g. uncontrolled diabetes, hypertension, blood diseases, bone diseases, smoking. - uncooperative patients - Patients with inadequate arch size and width. 40 Year(s) 60 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 20/09/2013 Faculty of Oral and Dental Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
11 EL-Saraya St. Manial, Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Osseointegration (Bone height) around the implant surface it will be evaluated Radiographically by using Digora in millimeter . it will be assessed at time of implant placement ,after 6 , 9 and 12 months
Secondary Outcome Implant stability (frequency resonance analysis) it will be measured by using Osstell mentor in ISQ every two weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic in prosthodontics department- Faculty of Oral and Dental Medicine Cairo University 11 EL-Saraya St. Manial, Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nourhan Ahmed Ragheb Aryamon-Kafr El Shikh Kafr El Shikh 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine Cairo University 11 EL-Saraya St. Manial, Cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amal Rekaby 11 EL-Saraya St. Manial, Cairo 11553 Egypt
Azza Farahat 11 EL-Saraya St. Manial, Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nourhan Ragheb doctor_nourhan@yahoo.com 00201005442919 Aryamon Kafr El Shikh
City Postal code Country Position/Affiliation
Kafr El Shikh 12345 Egypt Assistant Lecturer, prosthodontics department, Faculty of Oral and Dental Medicine Sinai University
Role Name Email Phone Street address
Public Enquiries Azza Farahat Azza_farahat56@yahoo.com 00201276096893 11 EL-Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Lecturer of Removable Prosthodontics faculty of oral and dental medicine .Cairo university
Role Name Email Phone Street address
Scientific Enquiries Amal Rekaby amalrt13@yahoo.com 00201006072458 11 EL-Saraya St. Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt professor of Removable Prosthodontics .faculty of oral and dental medicine Cairo University
REPORTING
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