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.: PACTR201702000942621 Date of Approval: 19/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title clinical evaluation of the stability of the immediately loaded dental implants with and without bone grafting materials in the maxillary premolar area
Official scientific title clinical evaluation of the stability of the immediately loaded dental implants with and without bone grafting materials in the maxillary premolar extraction sockets
Brief summary describing the background and objectives of the trial background The greatest alveolar bone volume reduction following an extraction occurs in the first 6 months and goes on over 2 years. In a prospective clinical study, it was demonstrated that 33% of the alveolar ridge width in posterior sites was lost within the first 3 months and 50% after 12 months. In addition, greater bone loss occurred at the buccal than at the lingual plate of the extraction (Bottini, Ricci, Piattelli, Perrotti, & Iezzi, 2012). Immediate implants have been advocated to preserve soft tissue contour and bone dimension, to minimize the period of edentulism and to reduce the overall treatment time. The concept of immediate placement of dental implants is a well accepted protocol even after removal of a tooth with periapical pathology. However, other studies have questioned that immediate implant placement can prevent bone resorption (Matteo et al., 2013). Different authors placed dental implants with immediate loading in fresh extraction sockets (occlusal load applied to temporary crowns positioned immediately on implants) from premolar to premolar regions, reporting a survival rate of 100%, with minimal bone crestal loss (Crespi, Capparè, Gherlone, & Romanos, 2012). To achieve both functional and aesthetic requirements, it might be necessary to plan implant placement after tooth extraction and socket grafting/ridge preservation. Bone graft materials have played on important role in periodontal regeneration for many years. To preserve alveolar bone width and height for implant placement or for prosthetic concerns, allografts, xenografts and alloplasts have been used to graft extraction sites (Hassan & Alagl, 2000). Objectives: To compare the clinical an
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied un restorable upper maxillary premolar
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/04/2014
Actual trial start date 30/11/2014
Anticipated date of last follow up 31/01/2016
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 Participants will be randomly assigned to either control or experimental groups with a 1:1:1 allocation as per a computer generated randomisation schedule. Participants will be randomized by using a computer-generated table of random numbers. Allocation concealment will be ensured, as the service will not release the randomization code until the patient has been recruited into the trial. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group immediate implant immediately placed and loaded implant in seven fresh extraction socket without using graft 7 Active-Treatment of Control Group
Experimental Group allograft bone immediately placed and loaded implants in seven fresh extraction socket in conjunction with allograft. 7
Experimental Group alloplastic grafting material. immediately placed and loaded implant in seven fresh extraction socket in conjunction with alloplastic grafting material. 7
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All patients should be medically free from any systemic disease that contraindicates implant placement. 2. Each patient should have an irrestorable premolar tooth that is indicated for extraction. 3. No sex predilection. 4. All patients should have good oral hygiene and should comply to instructional motivation to provide a reasonable prognosis for long-term benefit from the implant. 5. Patients should be more than 18 years old. 6. Patients should have intact buccal plate of bone. 7. Patients should have at least 3 to 5 mm of bone present beyond the root apex to guarantee implant primary stability. 1. Patients who are unable to undergo minor oral surgical procedure. 2. Patients with history of drug abuse. 3. Patients with history of psychiatric disorder. 4. Patients with unrealistic expectations regarding the esthetic outcome of implant therapy as those with a high smile line. 5. Teeth with acute or chronic periapical lesions. 6. Patients with vital anatomical structures in proximity to the proposed implants site, demonstrated by periapical and panoramic radiographs. 7. Patients who had habits that might jeopardize the osseointegration process as heavy smoking and alcoholism. 8. A patient with parafunctional occlusal habits that produce overload on the implant as bruxism and clenching. 9. Patients with insufficient vertical inter-arch space to accommodate the restorative components. 19 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
Yes 10/04/2014 cairo university faculty of oral and dental medicine research ethics committee
Ethics Committee Address
Street address City Postal code Country
11 El-Saraya St. - Manial - Cairo cairo 11,ElSaraya street Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical implant stability. tested by using the Periotest after sex month of the surgery Periotest values (PTV) of (-8 to 0)
Secondary Outcome ¿ Peri-implant marginal bone level. ¿Peri-implant bone density changes. gingival index¿plaque index: ¿papillary bleeding index: ¿ Probing Depth: ¿ Peri-implant marginal bone level. ¿Peri-implant bone density changes. measured by Cone-beam computed tomography immediate after the surgery after sex month ¿gingival index: ¿plaque index: ¿papillary bleeding index: ¿ Probing Depth: by using periodontal probe after 3 then 6 month from surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university 11 El-Saraya St. - Manial - Cairo cairo Fax: (+202) 2364637 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
huda hamed 397- alhram street- cairo- egypt cairo Egypt
huda hamed 397- alhram street- cairo- egypt cairo hmhl_5@yahoo.com 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,ElSaraya street ,Almanyal ,CAIRO ,EGYP cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Mohamed Sherien Hasan 11,ElSaraya street ,Almanyal ,CAIRO ,EGYP cairo cairo university Egypt
Prof. Dr. Amr Zahran 11,ElSaraya street ,Almanyal ,CAIRO ,EGYP cairo cairo university Egypt
Dr. Ahmed Reda 11,ElSaraya street ,Almanyal ,CAIRO ,EGYP cairo cairo university Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator huda mohamed hmhl_5@yahoo.com 00201159339772 alhram street
City Postal code Country Position/Affiliation
cairo Egypt libyan
Role Name Email Phone Street address
Public Enquiries ahmed reda dr.a.reda@gmail.com 00201006608568 11 El-Saraya St. - Manial - Cairo
City Postal code Country Position/Affiliation
cairo Egypt egyptian
Role Name Email Phone Street address
Scientific Enquiries amr zahran dramrzahran@gmail.com 00201200006635 11 El-Saraya St. - Manial - Cairo
City Postal code Country Position/Affiliation
cairo Egypt egyptian
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information