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IRCT20180416039327N4 IRCT 2021-02-09 Rasht University of Medical Sciences The effect of PRF and CGF on immediate implant treatment after the extraction of tooth with a lesion. The comparison of the effect of PRF and CGF on immediate implant treatment after the extraction of teeh with the periapical lesion. 2021-01-19 anticipated 27 Complete https://irct.ir/trial/53640 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is conducted using R software by statistician and patients are divided into three groups based on that. To divide participants into three groups of 9 people randomly, firstly people are given a number from 1 to 27. Then with software R version 3.4.3, they are divided into three random groups. A simple randomization method has been used. 2-3 Loss of teeth due to extraction. Intervention 1: Intervention group: After the extraction of the tooth with a periapical lesion in the first intervention group, 20 milliliters of blood sample is taken from the patient, and using a centrifuge device, Platelet-rich plasma is prepared. Platelet-rich plasma is placed in the tooth socket. The immediate implant is placed in the region. Intervention 2: Intervention group: After the extraction of the tooth with a periapical lesion in the second intervention group, 10 milliliter of blood sample is taken from the patient and using a centrifuge device, a concentrated growth factor is prepared. Concentrated growth factor is placed in the tooth socket. The immediate implant is placed in the region. Intervention 3: Control group: After the extraction of the tooth with a periapical lesion, the immediate implant is placed in the region. Yes - There is a plan to make this available What will be shared: If requested through an email, data will be sent. When: From the publication of the results To whom: Researchers Conditions: If the reason for needing the data is explained through an email, the data will be sent. Where to obtain: To the email Maryamzohary@gmail.com How to obtain: Will be sent immediately after receiving the email Comments:
public Maryam Zohary
dentistry faculty of Guilan University of Medical Science, Fuman-saravan ring road, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4188794755 +98 13 3348 6416 maryamzohary@yahoo.com Rasht University of Medical Sciences scientific Maryam Zohary
dentistry faculty of Guilan University of Medical Science, Fuman-saravan ring road, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4188794755 +98 13 3348 6416 maryamzohary@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Healthy patient in terms of systemic diseases Remaining roots Soft tissue and buccal bone plate in a normal distance from the CEJ Plaque index less than 25% Teeth with peri-apical lesion 20 years 60 years Both Smoking Pregnancy History of radiotherapy and chemotherapy Active infection Type 2 and 3 socket Advanced periodontitis and marginal bone recession Blood disease and diabetes Periapical lesion larger than 7 millimeter Bruxism K08.1 Loss of teeth due to extraction Treatment - Drugs Treatment - Drugs Other Intervention group: After the extraction of the tooth with a periapical lesion in the first intervention group, 20 milliliters of blood sample is taken from the patient, and using a centrifuge device, Platelet-rich plasma is prepared. Platelet-rich plasma is placed in the tooth socket. The immediate implant is placed in the region. Intervention group: After the extraction of the tooth with a periapical lesion in the second intervention group, 10 milliliter of blood sample is taken from the patient and using a centrifuge device, a concentrated growth factor is prepared. Concentrated growth factor is placed in the tooth socket. The immediate implant is placed in the region. Control group: After the extraction of the tooth with a periapical lesion, the immediate implant is placed in the region. Pain. Timepoint: 1 hour post-surgery, 6 hours post-surgery, 24 hours post-surgery, 48 hours post-surgery. Method of measurement: Using Visual Analog Scale (VAS) which ranges from 0 to 10. So that, 0 indicates no pain and 10 indicates severe pain. The healing of soft tissue. Timepoint: Immediately after the surgery, 1 month after the surgery, 3 months after the surgery, 6 months after the surgery. Method of measurement: Using Early Healing Index (EHI) which ranges from 0 to 4. 0 means complete closure of flap without fibrin line. 1 means complete closure of flap with thin fibrin line. 2 means complete closure of flap with fibrin clot. 4 means no closure of flap with partial necrosis. and 5 means no closure of flap with complete necrosis. The healing of the peri-apical lesion. Timepoint: Immediately after the surgery, 3 months after the surgery, 6 months after the surgery. Method of measurement: Using radiography, the decrease in the width of the lesion is reported in percent. The success and survival of the implant. Timepoint: 6 months after the surgery. Method of measurement: Using Implant Health scale (IHS) which ranges from 1 to 4. Score 1 means "complete health" of implant and includes no presence of pain and tenderness in function, no mobility, no secretion of exudate, and the reduction of bone height is less than 2 millimeters. Score 2 means "satisfying survival" of implant and includes no presence of pain and tenderness in function, no mobility, no secretion of exudate, and the reduction of bone height is 2-4 millimeters. Score 3 means "compromised survival" of implant and includes the possible presence of pain and tenderness in function, no mobility, possible secretion of exudate, the reduction of bone height is more than 4 millimeters or less than half of the implant's length, and probing depth is more than 7 millimeters. Score 4 means "complete failure" of implant and includes the presence of pain and tenderness in function, mobility, uncontrollable secretion of exudate, the reduction of bone height is more than half of the implant's length, and probing depth is more than 7 millimeters. The esthetic of gingiva in the mid-buccal of the implant. Timepoint: Immediately after the surgery, 1 month after the surgery, 3 months after the surgery, 6 months after the surgery. Method of measurement: Using Gingival Esthetic Index in the mid buccal which evaluates the difference of implant's buccal margin with adjacent tooth margin and ranges from 0-4. 0 means no difference, 1 means difference less than 1 millimeter, 2 means difference of 1- 2 millimeters, 3 means difference of 2-3 millimeters, and 4 means difference more than 3 millimeters. The esthetic of gingiva in the mesial and distal of the implant. Timepoint: Immediately after the surgery, 1 month after the surgery, 3 months after the surgery, 6 months after the surgery. Method of measurement: Using Gingival Esthetic Index in the mesial and distal of the implant which evaluates the height of the interdental papilla and ranges from 0-4. 0 means no presence of the papilla, 1 means the papilla's height is less than half of the gingival embrasure, 2 means the papilla's height is more than half of the gingival embrasure, 3 means complete growth of papilla into the interproximal space and 4 means the growth of papilla is over the interproximal space. Crestal bone level. Timepoint: Immediately after the surgery, 3 months after the surgery, 6 months after the surgery. Method of measurement: Using radiography, the distance of crestal bone from the implant is reported in millimeter. Plaque Index. Timepoint: Immediately after the surgery, 1 month after the surgery, 3 months after the surgery, 6 months after the surgery. Method of measurement: Using the O'Leary method. The patient is given a Fuschion tablet. The presence or absence of the stained deposites on the buccal, lingual, mesial, and distal surfaces is recorded and reported as the percent of stained surfaces to total surfaces. Bleeding index. Timepoint: Immediately after the surgery, 1 month after the surgery, 3 months after the surgery, 6 months after the surgery. Method of measurement: Using an O Michigan probe. The gingiva is probed in mesio-lingual, mesio-buccal, mid-buccal, mid-lingual, disto-buccal, and disto-lingual. After 30 seconds, the presence or absence of bleeding is recorded and the percent of the bleeding surfaces to total surfaces is reported. Rasht University of Medical Sciences Approved 2021-01-07 Ethics committee of Guilan University of Medical Sciences dentistry faculty of Guilan University of Medical Science, Fuman-saravan ring road, Rasht, Guilan, Iran Rasht Guilan Iran (Islamic Republic of)