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IRCT20130813014350N4 IRCT 2022-04-06 Rasht University of Medical Sciences Comparison of the effect of injection of platelet-rich fibrin gel and hyaluronic acid filler on interdental papilla reconstruction, a randomized clinical trial Comparison of the effect of injection of platelet-rich fibrin gel (Alb-PRF) and hyaluronic acid filler on interdental papilla reconstruction, a randomized clinical trial 2022-04-04 anticipated 33 Complete https://irct.ir/trial/62723 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method with 4 and 6 block sizes will be performed in both intervention and control groups. It should be noted that if the patient has more than one eligible incomplete papilla, these papillae are assigned to the same treatment group. Random allocation sequence generation is done using the site www.sealedenvelope.com. Allocation concealment is performed using opaque numbered, stamped and sealed randomly sequenced (SNOSE) envelopes, Blinding description: This test will be double-blinded. In this study, due to blood sampling in one group, it is not possible to blind the patient, and in any case, the patient will know in which group he will be studied. Also, due to the apparent difference between the two substances and the Alb-PRF preparation, it is not possible to blind the sample allocator. Therefore, in the present study, the outcome evaluator is not aware of the injectable substance in each papilla. Also, the analyst of the study results will not know about the study groups. A code will be assigned to each of the treated papillae for statistical analysis. N/A reconstruction of incomplete interdental papilla. Intervention 1: The treatment protocol was divided into 3 stages: pre-injection stage, or examination, injection stage and follow-up stage.The first visit will begin with the collection of demographic information, medical history and dentistry. Conscious consent is signed by patients. Primary periodontal treatment includes scaling and debridement of the gums. Plaque index is recorded in the teeth of the treated area. The distance between the tooth contact and the bone crest is measured by parallel periapical radiography. Before starting the test, the interdental papilla is evaluated according to the Nordland and Tarnow classifications and will be recorded in the relevant tables. Clinical photographs perpendicular to the target teeth will also be taken. Black triangles are measured clinically from the tip of the papilla to the point of interdental contact using a Williams periodontal probe and an acrylic stent...Intervention group: Hyaluronic acid filler injection............ After injection of local anesthesia, a hyaluronic acid filler with an approximate amount of less than 0.2 ml, 2-3 mm apical from the papilla tip and at an angle of 45 degrees to the longitudinal axis of the tooth will be injected with a 30 gauge insulin syringe. Patients will then be instructed in oral and written care after the injection. Patients are recalled in for a booster dose three weeks later. Intervention 2: Intervention group: Platelet-rich fibrin gel injection.......Preparation of Alb-PRF:From each patient, 9 ml of whole blood is collected in a plastic tube and immediately centrifuged at 700 g at room temperature for 8 minutes. After centrifugation, the top 2 ml layer (PPP) is collected in 2 ml syringes and heated at 75 ° C for 10 minutes to prepare a denatured albumin gel. The tube is then allowed to reach room temperature again for 10 minutes. Liquid PRF (layer on RBC) containing residual cells and growth factors is mixed with albumin gel and Alb-PRF gel is prepared ready for injection. Yes - There is a plan to make this available What will be shared: Comparison of the effect of injection of platelet-rich fibrin gel and hyaluronic acid filler on interdental papilla reconstruction, a randomized clinical trial 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: ا Bardia@gums.ac.ir How to obtain: Documents for writing a review article (for example, an invitation letter from the journal) should be provided Comments:
public Bardia Vadiati Saberi
Saravan-Fouman road
Rasht Iran (Islamic Republic of) 4188794755 +98 13 1326 3622 bardia@gums.ac.ir Rasht University of Medical Sciences scientific Bardia Vadiati Saberi
Saravan-Fouman road
Rasht Iran (Islamic Republic of) 4194173774 +98 13 1326 3622 bardia@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Written informed consent to participate in the study Having at least one deficient papilla Class I or II papillary defects according to the Nordland and Tarnow classifications Probing depth ≤4 mm Age between 20-75 20 years 75 years Both Gingivitis or periodontitis Diabetes, connective tissue diseases and other systemic diseases affecting periodontal tissues History of allergic reaction Pregnant and lactating women History of periodontal surgery in the area in the last 6 months Open contact (diastem) in the area Medications that cause gingival hyperplasia K06.0 Gingival recession Treatment - Other Treatment - Other The treatment protocol was divided into 3 stages: pre-injection stage, or examination, injection stage and follow-up stage.The first visit will begin with the collection of demographic information, medical history and dentistry. Conscious consent is signed by patients. Primary periodontal treatment includes scaling and debridement of the gums. Plaque index is recorded in the teeth of the treated area. The distance between the tooth contact and the bone crest is measured by parallel periapical radiography. Before starting the test, the interdental papilla is evaluated according to the Nordland and Tarnow classifications and will be recorded in the relevant tables. Clinical photographs perpendicular to the target teeth will also be taken. Black triangles are measured clinically from the tip of the papilla to the point of interdental contact using a Williams periodontal probe and an acrylic stent...Intervention group: Hyaluronic acid filler injection............ After injection of local anesthesia, a hyaluronic acid filler with an approximate amount of less than 0.2 ml, 2-3 mm apical from the papilla tip and at an angle of 45 degrees to the longitudinal axis of the tooth will be injected with a 30 gauge insulin syringe. Patients will then be instructed in oral and written care after the injection. Patients are recalled in for a booster dose three weeks later. Intervention group: Platelet-rich fibrin gel injection.......Preparation of Alb-PRF:From each patient, 9 ml of whole blood is collected in a plastic tube and immediately centrifuged at 700 g at room temperature for 8 minutes. After centrifugation, the top 2 ml layer (PPP) is collected in 2 ml syringes and heated at 75 ° C for 10 minutes to prepare a denatured albumin gel. The tube is then allowed to reach room temperature again for 10 minutes. Liquid PRF (layer on RBC) containing residual cells and growth factors is mixed with albumin gel and Alb-PRF gel is prepared ready for injection. Interdental papilla fill (black triangle area change). Timepoint: 0, 3, 6 months. Method of measurement: Measure the area of black triangles at specified intervals and examine the area changes in Photoshop. Patients' satisfaction with the results of the intervention. Timepoint: at the end of the sixth month. Method of measurement: visual analogue scale. Plaque index on the treated teeth. Timepoint: At the beginning and end of the study (0 and 6 months). Method of measurement: Loe index, the amount of microbial plaque accumulated on the treated teeth (especially in the interproximal area). Dental Research Centre, Guilan University of Medical Sciences Approved 2022-03-10 Ethics committee of guilan University of Medical Sciences Bustan Mellat, Ahmadzadeh Blvd., Shahid Amini Alley, Parvaneh dead end, No. 103, Rose Building Rasht Guilan Iran (Islamic Republic of)