An interventional study of Lutein / Zeaxanthin and Platelet rich fibrin in Osteogenesis, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.
Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.
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Patients grouping: Patients will be randomly divided into three groups:
Group A: Immediate implant placement with leaving the gap distance empty
Group B: Immediate implant placement then placement of PRF around the implant in the gap distance
Group C: Immediate implant placement then placement of lutein around the implant in the gap distance
Clinical evaluation:
Patients will be evaluated clinically for:
1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.
Radiographic evaluation:
conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Immediate implant placement with leaving the gap distance empty
Immediate implant placement then placement of PRF around the implant in the gap distance
Biological: Platelet rich fibrin
Immediate implant placement then placement of lutein around the implant in the gap distance
Dietary Supplement: Lutein / Zeaxanthin
lutein extract from lutein oral capsules
platelet rich fibrin extracted from patient's blood after centrifuging
bone formation
bone formation will be assessed by using conebeam CT
Time frame: 12 months
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Mansoura University