Diabetes Clinical Trial
— PRFOfficial title:
Evaluation of the Effect of Laser Biostimulation on Implant Covered With PRF in Controlled Diabetic Patients: A Randomized Clinical Trial
NCT number | NCT06444334 |
Other study ID # | 03430423 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | March 30, 2024 |
Verified date | June 2024 |
Source | National Research Centre, Egypt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
the goal of this clinical trial is to evaluate laser biostimulation effect on osseointegration of implant covered by PRF(platelet rich fibrin) in controlled diabetic patients with compromised healing potential. METHODS: The study was conducted on type 2 controlled diabetic patients receiving 22 implants covered with PRF inserted in posterior maxilla or mandible. Implants were divided randomly into 2 groups. Group1: control group (received no laser irradiation), group2: received diode laser. Peri-implant new bone density and secondary stability were assessed using cone-beam computed tomography and Anycheck device respectively. Density was evaluated immediately post implant insertion and after 5 months, while implant stability was performed 5 months post implant insertion. Statistical analysis was executed significance level P ≤ 0.05.
Status | Completed |
Enrollment | 22 |
Est. completion date | March 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. nonsmoker patients, 2. age range 30 -60 years, 3. Glycosylated hemoglobin (Hb1C) ranges between 7-8, 4. no other systemic disease, 5. vital signs are normal (blood pressure, temperature, pulse rate, respiratory rate), 6. missing 1st or 2nd mandibular or maxillary premolars or molars, 7. lab investigations are within normal (CBC. liver function AST &ALT, kidney function urea &creatinine, Ca level, 25OH Vit D), 8. no need for alveolar bone grafting, and 9. no soft or hard tissue pathology. Exclusion Criteria: 1. smoker patient, 2. Glycosylated hemoglobin (Hb1C) more than 8 or less than 7, 3. age less than 30 or more than 60, 4. presence of other systemic diseases, 5. vital signs are not normal, 6. lab investigations are not normal (CBC, liver function, kidney function), 7. need for alveolar bone grafting and 8. present soft or hard tissue pathology. |
Country | Name | City | State |
---|---|---|---|
Egypt | Oral Surgery Clinic at National Research Centre | Guiza |
Lead Sponsor | Collaborator |
---|---|
National Research Centre, Egypt |
Egypt,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Per-implant bone density measurements | Digital software program was used for quantitative mean bone density measurements of all the captured radiographs produced by CBCT for both groups. Multiplanar resolution screen (MPR) was selected showing radiographic images of the mandible and maxilla in sagittal and coronal views to quantify bone radiodensity in mesiodistal and buccolingual surfaces respectively , a constant exact area was selected for each view with area =1 5.2mm2, width = 2.00mm, and height = 7.60mm. Five readings of radiodensity in Hounsfield units (HU statistics) were collected by blind investigator for each peri-implant surface (mesial, distal, buccal, and lingual) with slice thickness of 0.5mm. Finally, the mean density values were calculated and tabulated concerning sagittal and coronal views in each implant | at immediate day of surgery(baseline) and after 5 months for the same patients | |
Secondary | Implant stability measurements | AnyCheck device (AnyCheck, Neobiotech Co., Ltd. E-space #1001, 36, Digital-ro 27-gil, Guro-gu, Seoul, Korea, 08381) was utilized 5 months (2nd stability) post implant insertion. AnyCheck is an implant stability meter that measures the stiffness of the alveolar bone-implant interface through a tapping-motion. The degree of osseointegration is calculated in terms of IST (Initial Stability Test) value between 30 to 85. AnyCheck was turned on, then, the tip of the tap¬ping rod maintained contact angle between 0 to 30 degrees with healing abutment. The START button was gently pressed while holding the device stable, the measured value displayed on the LCD screen was recorded. The smaller the measured value, the weaker the degree of osseointegration. Mesiodistal and buccolingual sides of the implant were measured, five IST readings for each side were repetitively recorded by blind examiner and the mean reading was calculated and tabulated | only after 5 months from implant insertion |
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