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.: PACTR201610001197438 Date of Approval: 11/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the stability of short implants in the posterior maxilla and the posterior mandible using the Periotest: controlled clinical trial
Official scientific title Evaluation of the stability of short implants in the posterior maxilla and the posterior mandible using the Periotest: controlled clinical trial
Brief summary describing the background and objectives of the trial An inadequate bone volume and a low bone density, i.e. quality D4 bone in the posterior maxilla is a frequent anatomical restriction for implant placement. The loss of bone can strongly influence the choice of the most appropriate rehabilitation in edentulous patients. Maxillary sinus grafting appears to be the most predictable hard tissue augmentation technique in implant dentistry and long-term implant survival in the grafted maxillary sinus is comparable to non-grafted sites but necessitates additional surgery, cost, and time. In addition, patients may decline the procedure due to added risk and morbidity (Harry 2011).Short implant placement in the posterior mandible is well documented in the literatures as successful treatment modality for rehabilitation of edentulous patients. Short-length (8-mm) dental implants offer an effective treatment alternative to bone grafting and nerve lateralization for the height-deficient atrophic posterior mandible(Grant, Pancko, and Kraut 2009, Guljé et al. 2013). The aim of this study is to evaluate the stability of short implants in the posterior maxilla and the posterior mandible using the Periotest.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied atrophic posterior maxilla and mandible,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/11/2014
Actual trial start date 03/11/2014
Anticipated date of last follow up 04/04/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
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 Non-randomised Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group short implant placement in atrophic posterior maxilla 1 year after placement of short implant in posterior maxilla, CBVT will done within 24 hours. after 4 months the stability of implant will measured by using Periotest and placement of supra stracture. the stability will measured again 3 months after loading and CBVT will taken to measure the marginal bone lose around implant. 15
Control Group short implant placement in atrophic posterior mandible 1 year after placement of short implant in posterior mandible, CBVT will done within 24 hours. after 4 months the stability of implant will measured by using Periotest and placement of supra stracture. the stability will measured again 3 months after loading and CBVT will taken to measure the marginal bone lose around implant 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Any partially edentulous patient missing teeth in the posterior area requiring 1 to 2 dental implants. 2. Patient age: 18 years or older 3. Able to sign an informed consent form. 4. Patients with no systemic diseases. 5. Patients who are cooperative, motivated, and hygiene conscious. 6. The recipient site of the implant should be free from any pathological conditions. 7. Vertical bone heights at implant sites have to be 8.5 - 10 mm above the mandibular canals and 7.5 - 9 mm below the maxillary sinuses. 8. Bone thickness has to be at least 6 mm. 1. Systemic contraindications to implant surgery 2. Patients in the growth stage with partially erupted teeth 3. Patient subjected to irradiation in the head and neck area 4. Immunosuppressed or immunocompromised 5. Patient treated or under treatment with intravenous amino-bisphosphonates 6. Patients with untreated periodontitis 7. Patients with poor oral hygiene and motivation 8. Uncontrolled diabetes and heavy smokers 9. Pregnant or nursing 10.Substance abuse 11. Psychiatric problems or unrealistic expectations 12. Lack of opposite occluding dentition in the area intended for implant placement 13.Acute or chronic infection/inflammation in the area intended for implant placement 18 Year(s) 40 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 29/09/2014 the Ethics Committee of Scientific Research - faculty of oral and dental medicine ¿ Cairo University
Ethics Committee Address
Street address City Postal code Country
11 Al Saraya - Al Manil Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome stability of the implants using Periotest T1 = loading stage (4 months postoperatively) T2 = 3months after loading
Secondary Outcome marginal bone level around implants using CBVT T0 = within 24 hours after implant placement T2= 3 MONTHS AFTER LOADING
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Periodontology department ¿ Cairo University 11 Al Saraya - Al Manil Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Fouad Taib ( personal) maadi Cairo 11728 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 Al Saraya street - Al Manil Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fouad Hassan Taib 28 dosoky street - maadi Cairo 11728 Egypt
Ahmed Reda 15 al nasr street - maadi Cairo 11728 Egypt
Amr Zahran 10 Al-Nakhil Street Mohandseen Giza 12627 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator fouad taib drfouadtaib@yahoo.com 00201092582341 28 dosoky street - maadi
City Postal code Country Position/Affiliation
cairo 11728 Egypt PhD candidate
Role Name Email Phone Street address
Public Enquiries ahmed reda dr.a.reda@gmail.com 00201006608568 15 al nasr street - maadi
City Postal code Country Position/Affiliation
cairo 11728 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries amr zahran dramrzahran@gmail.com 00201223101977 10 al-nakhil street - mohandseen
City Postal code Country Position/Affiliation
cairo 12627 Egypt professor
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