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.: PACTR202402627986765 Date of Approval: 06/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Low Level Laser Therapy on Delayed Implant Placement with Early Loading Protocol
Official scientific title The Effect of Low Level Laser Therapy on Delayed Implant Placement with Early Loading Protocol
Brief summary describing the background and objectives of the trial Different innovation of implant designs, materials and technology are introduced to enhance osseo-integration. Such innovations result in shortening the healing time which allow for such intended approach of immediate or early loading protocol. Among these technology, the use of low level laser (LLL) has been suggested with the aim to accelerate the osseo-integration and bone to implant contact. Low level laser therapy LLLT can promote new bone formation by including differentiation of osteoblasts and enhancing angiogenesis which play vital role of bone regeneration. Its mechanism is through increasing of š›½- endorphins, increasing the threshold of pain, production of adenosine triphosphate ATP, improving micro-circulation and lymphatic flow which by turn provide the reduction of the post-operative edema. The present randomized controlled clinical and radiographical study will be conducted to evaluate the effect of LLLT on delayed implant placement with early loading protocol. The aim of the present study is to evaluate the effect of low level laser therapy on delayed implant placement with early loading protocol.
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: Surgery
Anticipated trial start date 01/04/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 24
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low level laser therapy N/A 4 sessions postoperative Low level laser therapy as adjunctive therapy to enhance osseo-integration of dental implant 12
Control Group Control N/A Intraoperative and postoperative till extubation Delayed Dental Implant placement in healed sites in posterior area ( 6 months after extraction) with early loadingĀ protocol 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Complete healing of the edentulous site of at least 6 months. - Adequite bone dimensions for implant placement without the need for guided bone regeneration procedures. - Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene. - Any uncontrolled systematic diseases that can affect healing process such as diabetes. - Patients with bruxism and parafunctional habits. -Bone density D4 or D5. -Limited interarch restoration space. - Pregnant women. -Smokers. Adult: 19 Year-44 Year 20 Year(s) 45 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 22/04/2022 Research Ethics Committee Faculty of Dentistry Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome implant Stability At time of implant placement time, 2 months and 12 months postoperative
Primary Outcome Crestal bone height At time of implant placement time, 2 months and 12 months postoperative
Secondary Outcome Healing index At first, second, and third weeks postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University. El Gash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Yasmin Hamdy Ahmed Fekry Ahmed El bahr street Faculty of dentistry Tanta University Tanta 31773 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral Medicine Periodontology Oral Diagnosis and Radiology Department Faculty of Dentistry Tanta University. El Gash street Medical Campus Tanta 31773 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Yasser Mohammed El Makaky El Gash street Medical Campus Tanta 31773 Egypt
Ahmed Mohamed Badr El Gash street Medical Campus Tanta 31773 Egypt
Yasmin Hamdy Ahmed Fekry Ahmed El Gash street Medical Campus Tanta 31773 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yasser Mohamed El Makaky yassermakaky@dent.tanta.edu.eg 00201555013680 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Oral Medicine Periodontology Oral Diagnosis and Oral Radiology Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Badr Ahmed_bader@dent.tanta.edu.eg 00201004699564 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Lecturer of Oral Medicine Periodontology Oral Diagnosis and Oral Radiology Faculty of Dentistry Tanta University
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
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com 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