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IRCT20130813014350N5 IRCT 2022-10-16 Rasht University of Medical Sciences Investigating growth factors and complications after implant treatment A comparative study of the effect of leukocyte and fibrin-rich plasma (L-PRFin soft tissue thickness, tissue healing rate, pain and discomfort after peri-implant treatment in people needing dental implants (split- mouth randomized controlled trial) 2022-09-23 anticipated 10 Complete https://irct.ir/trial/65504 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the type of treatment on the left and right sides of the permuted block randomization method. randomization) with a block size of 4 will be used. Considering that A represents the right side and B represents the left side, the randomization process will be as follows (randomization was done with SAS version 9 software): Seed: 51660630849336 Block sizes: 4 Actual list length: 8 block identifier, block size, sequence within block, treatment • 1, 4, 1, Group B • 1, 4, 2, Group B • 1, 4, 3, Group A • 1, 4, 4, Group A • 2, 4, 1, Group B • 2, 4, 2, Group B • 2, 4, 3, Group A • 2, 4, 4, Group A, Blinding description: This trial will be conducted in a double-blind manner. In this category of studies, there is no possibility of blinding the patient due to blood sampling when he is subjected to surgery for the purpose of the experimental group. Therefore, in the present study, the outcome evaluator will not know the type of sample to be evaluated, and also The analyst of the study results will not know about the studied groups. N/A Soft tissue thickness, tissue healing rate, pain and discomfort after treatment around dental implants. This study will be an interventional split-moth study that examines the effect of using L-PRF on the success of dental implants in 1 target group and 1 control group. At the beginning of the plan, the consent form will be completed by the patient. Then, the patient's personal characteristics such as age, gender, medical history and drug use are recorded.(Checklist No. 1) In this study, 10 patients referring to the periodontal surgery department of Gilan Faculty of Dentistry who need to place implants in the mandibular premolars will be selected based on the inclusion criteria.After the external and intraoral examinations, each patient is given full training regarding the control of oral plaque, and if dental plaque is observed, they receive scaling and root planing. Measuring the thickness of the buccal soft tissue by periodontal probe in millimeters. It will be done. On the day of the surgery, the patient will first rinse his mouth with 0.12% chlorhexidine and we will use iodine as an extraoral antiseptic.Local anesthesia (lidocaine HCl 2% with epinephrine 1:100,000) will be injected. Preparation of L-PRF: 9 ml of whole blood is collected from each patient in a plastic tube and immediately centrifuged for 12 minutes at 2700 rpm (or power 400 g at room temperature in a DUO Quattro centrifuge (49 Rue Gioffredo, 06000 Nice, France) will be centrifuged by the relevant technician who is a research associate (resident), and because it takes less time, it is easier to prepare. Then the fibrin clot which is formed in the middle of the tube (exactly between the red blood cells below and the cell-free plasma in the upper part), after the upper plasma is removed, it is separated from the lower blood cells using sterile forceps and scissors and transferred to a sterile compress.After preparing the osteotomy cavity for implant placement, the samples are randomly placed in 2 groups: control group 1, where no material is placed around the implant, group 2, where L-PRF is placed around the implant on the buccal side under the flap. For all samples, the DENTIS implant is placed in two stages. In both groups, full coverage will be done using 0-4 Silk suture thread and in a simple loop. Gelofen was prescribed for patients before surgery and 6 hours after surgery to continue using it if there is pain. The patient is advised to avoid eating hard and sticky foods or using a toothbrush in the surgical area and not to use the removable prosthesis for a week. After a week, the suture is removed. The final restoration will be placed after 3 months. The surgery is performed by a periodontist and the evaluation of the samples is performed by a periodontist who is unaware of the type of samples. Patient follow-up by a research associate (resident) to evaluate clinical parameters at baseline and 6 weeks later to check the thickness of soft tissue around the implant as a primary outcome and to evaluate pain during 7 days after surgery (days 7, 3, 2, 1 ) and the amount of soft tissue improvement on day 7 and day 14 after surgery will be performed as a secondary outcome. Clinical parameters include soft tissue thickness (measured by periodontal probe in millimeters), patient pain (VAS index), soft tissue improvement (Landry Index) , which includes tissue color, BOP, epithelialization of wound margin, presence of tissue granulation And the presence of pus.. Yes - There is a plan to make this available What will be shared: Comparison of the effect of leukocyte and fibrin-rich plasma on the change of soft tissue thickness, tissue healing rate, pain and discomfort after peri-implant treatment in people who need dental implants, a split mouth randomized controlled clinical trial. All data can be shared after de-identifying individuals. When: 6-12 months after result publication To whom: Researchers working in academic institutions Conditions: Use in higher level studies such as systematic review studies Where to obtain: Bardia@gums.ac.ir How to obtain: Documents for writing a review article (for example, an invitation letter from the desired journal) should be provided Comments:
public Bardia Vadiati Saberi
Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road, Rasht, Iran
Rasht Iran (Islamic Republic of) 4194173774 +98 13 1326 3622 bardia@gums.ac.ir Rasht University of Medical Sciences scientific Bardia Vadiati Saberi
Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road, Rasht, Iran
Rasht Iran (Islamic Republic of) 4188794755 +98 13 1326 3622 bardia@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Age 20-60 Partial edentulous patient The plaque index before surgery is less than 25% 20 years 60 years Both smokers Pregnant and lactating women History of radiation therapy and chemotherapy Patients with active symptoms of infection such as pain, swelling, pus and abscess Untreated advanced periodontitis Blood disease and diabetes Hyperthyroidism High blood pressure Treatment - Surgery This study will be an interventional split-moth study that examines the effect of using L-PRF on the success of dental implants in 1 target group and 1 control group. At the beginning of the plan, the consent form will be completed by the patient. Then, the patient's personal characteristics such as age, gender, medical history and drug use are recorded.(Checklist No. 1) In this study, 10 patients referring to the periodontal surgery department of Gilan Faculty of Dentistry who need to place implants in the mandibular premolars will be selected based on the inclusion criteria.After the external and intraoral examinations, each patient is given full training regarding the control of oral plaque, and if dental plaque is observed, they receive scaling and root planing. Measuring the thickness of the buccal soft tissue by periodontal probe in millimeters. It will be done. On the day of the surgery, the patient will first rinse his mouth with 0.12% chlorhexidine and we will use iodine as an extraoral antiseptic.Local anesthesia (lidocaine HCl 2% with epinephrine 1:100,000) will be injected. Preparation of L-PRF: 9 ml of whole blood is collected from each patient in a plastic tube and immediately centrifuged for 12 minutes at 2700 rpm (or power 400 g at room temperature in a DUO Quattro centrifuge (49 Rue Gioffredo, 06000 Nice, France) will be centrifuged by the relevant technician who is a research associate (resident), and because it takes less time, it is easier to prepare. Then the fibrin clot which is formed in the middle of the tube (exactly between the red blood cells below and the cell-free plasma in the upper part), after the upper plasma is removed, it is separated from the lower blood cells using sterile forceps and scissors and transferred to a sterile compress.After preparing the osteotomy cavity for implant placement, the samples are randomly placed in 2 groups: control group 1, where no material is placed around the implant, group 2, where L-PRF is placed around the implant on the buccal side under the flap. For all samples, the DENTIS implant is placed in two stages. In both groups, full coverage will be done using 0-4 Silk suture thread and in a simple loop. Gelofen was prescribed for patients before surgery and 6 hours after surgery to continue using it if there is pain. The patient is advised to avoid eating hard and sticky foods or using a toothbrush in the surgical area and not to use the removable prosthesis for a week. After a week, the suture is removed. The final restoration will be placed after 3 months. The surgery is performed by a periodontist and the evaluation of the samples is performed by a periodontist who is unaware of the type of samples. Patient follow-up by a research associate (resident) to evaluate clinical parameters at baseline and 6 weeks later to check the thickness of soft tissue around the implant as a primary outcome and to evaluate pain during 7 days after surgery (days 7, 3, 2, 1 ) and the amount of soft tissue improvement on day 7 and day 14 after surgery will be performed as a secondary outcome. Clinical parameters include soft tissue thickness (measured by periodontal probe in millimeters), patient pain (VAS index), soft tissue improvement (Landry Index) , which includes tissue color, BOP, epithelialization of wound margin, presence of tissue granulation And the presence of pus. The thickness of the soft tissue around the implant. Timepoint: Baseline and 6 weeks later. Method of measurement: Measurement by periodontal probe in mm. Postoperative pain assessment. Timepoint: during 7 days after surgery (days1,2,3,7). Method of measurement: Visual analog scale(VAS) index. Soft tissue healing rate. Timepoint: Day 7 and day 14 after surgery. Method of measurement: (Landry Index) which includes tissue color, BOP, epithelialization of wound margin, presence of tissue granulation and presence of pus. Dental Research Center, Guilan University of Medical Sciences Approved 2022-08-21 Ethics committee of Guilan University of Medical Sciences No. 103, Rose Building, Parvaneh Dead End, Koi Shahid Amini, Ahmadzadeh Blvd., Bostan Mellat Rasht Guilan Iran (Islamic Republic of)