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IRCT20211221053471N1 IRCT 2023-12-23 Babol University of Medical Sciences Investigating the effect of gel containing chitosan in grade II furcation involvement defects Clinical and radiographic investigation of the effect of gel containing chitosan in grade II furcation involvement defects 2023-12-22 anticipated 44 Complete https://irct.ir/trial/72817 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process is done based on the Kitset.ir site and the random numbers option, and in each of the samples, a gel containing chitosan and a gel without chitosan are randomly placed.According to the mentioned site, group A includes numbers 29,7,6,8,25,22,16,43,27,31,2,28,44,33,23,9,10,4,12,35,11,32 and group B including numbers 17,37,38,42,26,20,14,24,21,3,13,36,34,39,40,19,15,30,41,5,18,1 is, Blinding description: Me and the professor of surgery, as a researcher and performing surgeries, will not have any information about the contents of the gels, nor will the data analyst and the participants have any information. What does the gel contain. N/A grade II furcation involvement defects. Intervention 1: Intervention group: A gel containing chitosan is randomly placed in each of the samples. Intervention 2: Control group: Chitosan-free gel is randomly placed in each sample. Yes - There is a plan to make this available What will be shared: Data and outcome changes are available When: After completing the study To whom: All researchers related to the subject Conditions: According to the relevant protocol Where to obtain: Researcher in charge via e-mail How to obtain: E-mail and then check the reason for the need for data Comments: Confidentiality of patients' personal information is maintained.

public Parastoo Madieh

Second alley on the leftوHar St. 21, Shahabnia intersection,Babol

Babol Iran (Islamic Republic of) 4718773564 +98 991 151 0075 parastoomadieh@gmail.com Babol University of Medical Sciences scientific Parastoo Madieh

Second alley on the leftوHar St. 21, Shahabnia intersection,Babol

Babol Iran (Islamic Republic of) 4718773564 +98 51 3840 5446 parastoomadieh@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) All patients with moderate to severe chronic periodontitis with grade II furcation involvement on the lingual or buccal side of the first or second molar of the lower jaw and need treatment. .Index plaque before surgery should be less than 20% The horizontal probe depth (Horizontal Probe Depth, HPD) in the involved areas is greater than or equal to 3. no limit no limit Both Having a systemic disease Need for prophylactic antibiotics to prevent bacterial endocarditis Use of medications that interfere with periodontal healing smoking Presence of contraindications for periodontal surgery Teeth with anatomical complications such as CEP, bifurcation ridge, accessory canal and concavity More tooth mobility than class II Presence of decay and repair in the furcation area Presence of evidence of periapical pathology in the clinical or radiographic appearance of the tooth in question The possibility of the patient's lack of acceptable cooperation after the initial periodontal treatment Having a history of coagulation problems XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified Treatment - Surgery Treatment - Surgery Intervention group: A gel containing chitosan is randomly placed in each of the samples. Control group: Chitosan-free gel is randomly placed in each sample. (Vertical probing depth) VPD: means the distance between the margin of the gum to the point where the gum epithelium adheres to the surface of the tooth, which is measured by the probe. To measure the depth of the pocket, the calibrated periodontal probe is inserted from the facial, lingual, mesial and distal surfaces of the tooth so that the tip of the probe is parallel to the longitudinal axis of the tooth, enters the gingival sulcus and the depth of the pocket is measured. The numbers obtained in the file related to Each patient is registered. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged. (Vertical clinical attachment level) VCAL: First, the CEJ of the desired tooth is determined by a probe, the distance from the edge of the margin to this area is recorded by the probe, the difference of this number is the depth of probing VCAL. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged. (Horizontal probing depth) HPD: is the horizontal entry of the probe into the furcation. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged. Gingival recession: if the gingival margin is below the CEJ, we consider its existence as positive, and if the gingival margin is above the CEJ, this parameter is recorded as absent. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged. Gingival Index: based on the percentage of tooth surfaces. which has inflammation, determines the severity and existence of gingivitis. and Subtraction Radiography based on the formation or lack of bone formation in the parallel periapical. Timepoint: At the beginning of the study (before surgery) and 6 months after surgery. Method of measurement: Clinical parameters are measured using a periodontal probe by the examiner. and the parameters are recorded. The initial radiograph (before surgery) will be taken using Rinn Xcp.Dentsply (Sirona.USA-Newyork) protective film and PSP digital sensor (Soredex.Helsinki-Finland) size 2 and for record keeping The occlusion of the patient is performed using Duralay (Reliance.Illiniois-America) molding material from the bite block area of the film holding the patient's occlusion. The images are processed and then saved using PCT (Soredex.Helsinki-Finland) and DFW2.5 software (Soredex.Helsinki-Finland) and recorded 6 months later using a byte block and PSP digital sensor (Soredex. Helsinki-Finland) size 2 and the same exposure parameters, a second radiograph is performed. Then, digital subtraction of the images before and after the treatment is done by Photoshop CS6 software (Adobe systems.California-America). In the cases where the difference in density is observed as radiolucency as analysis, the cases that were observed as radiopacity as bone formation in the area and in cases where the change that is not observed in terms of density are considered unchanged. Babol University of Medical Sciences Approved 2023-09-27 Ethics Committee of Babol University of Medical Sciences Second alley on the leftوHar St. 21, Shahabnia intersection,Babol Babol Mazandaran Iran (Islamic Republic of)