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.: PACTR202209859434234 Date of Approval: 15/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation Of Osseointegration of Immediately Placed And Loaded Dental Implants With Nanocrystalline Hydroxyappatite Particles In The Esthetic Zone (A Randomized Controlled Clinical Trial)
Official scientific title Evaluation Of Osseointegration of Immediately Placed And Loaded Dental Implants With Nanocrystalline Hydroxyappatite Particles In The Esthetic Zone (A Randomized Controlled Clinical Trial)
Brief summary describing the background and objectives of the trial Immediate implant placement as a single surgical procedure has shown many advantages. Ideal implant positioning is an important advantage, socket bone preservation, and also decreasing treatment time. Several studies have reported a decreased amount of bone loss when using immediate implants directly after tooth extraction. Adequate peri-implant bone support is needed for successful immediate and long-term implant stability. Many procedures have been suggested to increase alveolar bone height and width. Xenografts have proven to be one of the most successful but also widely used grafting materials these days as they proved to be a good substitute for autogenous bone grafts. This success is due to their osteoconductive properties, and their density which shows great stability to the implant as they also supply all the needed minerals for bone formation. An example of one of the osteoinductive biomaterials is the NanoBone® (Nanocrystalline hydroxyapatite particles), which is a granular material composed of nanocrystalline hydroxyapatite mixed in silica gel matrix showing a great advantage of the nanostructural bio-materials. This bone substitute material shows many advantages as it proved to be safer, faster bone formation, complete bone remodeling, and very high performance through the nanostructure. The aim of the present study is to evaluate the osseointegration of NanoBone® (Nanocrystalline hydroxyapatite particles) around immediately placed and loaded dental implants in the esthetic zone by measuring Implant stability and Marginal bone loss.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2021
Actual trial start date 01/12/2021
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 16
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL N/A
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nanobone grafting material N/A Once at the time of insertion, once after 4 months In this group patient has done extraction and immediate implant placement in maxillary anterior region then bone graft was applied to fill the jumping gap 8
Control Group Xenograft N/A Once at the time of insertion, once after 4 months Extraction and immediate implant placement in the maxillary anterior region then bone graft was applied to fill the jumping gap 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hopeless tooth in the maxillary aesthetic area indicated for extraction and immediate implant placement. Jumping gap between the implant and labial wall ≥ 2mm. Intact four-wall sockets of the teeth. History of systemic diseases that would contraindicate surgical treatment. Acute infection in surgical sites. Long-term non-steroidal anti-inflammatory drug therapy. Periodontal disease with bone loss. Known allergy to any of the materials used in the study. Patients with severely atrophic ridges require a staged grafting procedure. parafunctional habits. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 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 21/11/2021 Institutional Review Boards IRB at the faculty of dentistry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Marginal bone loss Immediate After 4 months After 6 months
Secondary Outcome Implant stability Immediate After 4 months After 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Alexandria University Teaching Hospital and operated in the Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champollion Street, Qesm Bab Sharqi, Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed El Halfawy Smouha Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University Champolion St., Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdelaziz Fahmy Khalil 17 Champolion St., Azarita Alexandria 21521 Egypt
Mohamed Shokry 17 Champollion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
Ahmed El Halfawy 17 Champolion St., Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Abdelaziz Fahmy Abdelaziz.fahmy22@gmail.com 00201011103477 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Oral and Maxillofacial Surgery Oral and Maxillofacial Surgery Department Faculty of Dentistry Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Shokry moh.shokry@gmail.com 00201113290990 17 Champollion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Associate Professor of Oral And Maxillofacial Surgery Faculty of Dentistry Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
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