Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05478811
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-25
Brief Title:
Evaluation of RANKLOPG Levels in Gingival Crevicular Fluid at 1st and 3rd Months of Activation of NaOCl With ErCr YSSG Laser in Root Canal Treatment
Sponsor:
Yuzuncu Yıl University
Organization:
Yuzuncu Yıl University
Study Overview
Official Title:
Evaluation of RANKLOPG Levels in Gingival Crevicular Fluid at 1st and 3rd Months of Activation of NaOCl With ErCr YSSG Laser in Root Canal Treatment of Mandibular Molar Teeth With Periapical Lesions
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic Apical Periodontitis CAP is a disease caused by bacterial infection of the dental pulp and characterized by inflammation of the periradicular tissues This disease is often the result of untreated caries and accompanied by the destruction of periapical bone and soft tissues can cause tooth loss Inflammatory periapical lesion is observed in the radiological examination of teeth diagnosed with Chronic Apical Periodontitis This periapical lesion manifests as a host defense response to microbial challenge caused by infected pulp necrosis Polymorphonuclear leukocytes T and B lymphocytes macrophages and plasma cells and many inflammatory cells are involved in host defense These inflammatory cells especially macrophages mediate the immunological response seen in chronic apical periodontitis Diagnosis and evaluation of apical periodontitis are made with conventional periapical radiographs However radiographic evaluation has some limitations These limitations can be listed as the radiolucent area on the x-ray being related to the amount of bone loss caused by the lesion the extent of the bone loss to the cortical bone the variability of the bone structure in maxilla and mandibula and the operator experience The main goal in root canal treatment is to eliminate microorganisms and products in the root canal system with the irrigation agents which we use NaOCl which is frequently used for this purpose is used alone or activated by ErCr YSSG laser It has been reported that NaOCl which is activated by laser increases the elimination of microorganism in the root The gingival crevicular fluid is an inflammatory exudate collected from the gingival sulcus Peripheral body fluids such as gingival crevicular fluid can often be used as descriptors in acute and chronic inflammation The collection of gingival crevicular fluid is a very simple and risk-free method for the patient Biomarkers such as inflammatory mediators and neuropeptides can be detected in the gingival crevicular fluid of teeth with periodontal disease At the molecular level osteoclast activation is regulated by the triple molecule interaction of RANK RANKL and OPG RANK Receptor Activator of Nuclear Factor Kappa B binds to its ligand RANKL while synthesizing both mature osteoclasts and its progenitor cells RANKL provides osteoclast differentiation and activation OPG Osteoprotegerin ligand is a decoy receptor for RANKL thus inhibiting osteoclast differentiationWhen the investigators look at the studies in the literature there are many studies showing that the level of RANKLOPG in the gingival crevicular fluid decreases with periodontal treatment Also when the investigators look at the studies on endodontic treatment many mediators such as MMP-8 IL-8 Substance P Neurokinin A and their changes after root canal treatment were examined However no study was found examining RANKLOPG levels in gingival crevicular fluid after root canal treatment At the same time it is known that gingival crevicular fluid is used as a descriptive method in the determination of bone healing after periodontal treatment However in the literature conventional radiological methods and tomography are seen as the most frequently used examination methods in the determination of bone healing after root canal treatment of lesioned teeth The number of studies in which the gingival groove fluid collection method which is much less invasive than these methods is used as a descriptive method is quite limited In line with this information it is planned to conduct the research described below by examining the effect of activation with ErCr YSSG laser on the RANKLOPG levels in the gingival crevicular fluid in the 1-3 month bone healing period after root canal treatment in lesioned teeth
Detailed Description:
The study is planned to be conducted on a total of 30 healthy patients aged between 18-50 years who were diagnosed and followed up in the Department of Endodontics Faculty of Dentistry of Yüzüncü Yıl University The sample size was calculated in the GPower 31 program based on the data in the study of Arslan et al In this study the minimum required number of patients was determined as 30 by taking effect size 1252193 alpha005 and power090 Mandibular first and second molars diagnosed with Chronic Apical Periodontitis will be included in the study group Patients who do not have periapical lesions have open apex have a probing depth of more than 3 mm and have bleeding during probing will not be included in the study group RANKL and OPG levels in the gingival crevicular fluid will be determined using the ELISA test RANKL and OPG levels in the gingival crevicular fluid of teeth with periapical lesions which are indicated for root canal treatment will be recorded with Periopaper Oraflow New York NY
Before taking a sample of gingival crevicular fluid the tooth will be washed with water dried and the plaque and deposits on it will be cleaned with cotton Then the tooth will be isolated with a cotton pellet and a suction and a Periopaper Oraflow New York NY will be placed 1-2 mm into the gingival sulcus until slight resistance is felt and a sample of gingival crevicular fluid will be taken after waiting for 30 seconds Specimens contaminated with blood or saliva will not be included in the study Then these samples will be stored at -80C The access cavity will be opened to the teeth under local anesthesia with a 2 milliliter Ultracain D-S Aventis The Netherlands The working length will be determined with a 15 K-files Mani Inc Tochigi Japan with the apex locator DentsplyMaillefer UK and radiographic imaging
The preperation of the root canals will be completed by ProTaperNext DentsplyMaillefer Baillagues Switzerland up to the X3 instrument as standard in each patient 2 ml of 525 NaOCl solution will be used at each file change during preperation During the irrigation process a 2 milliliter dental injector and a 27 gauge dental needle tip will be used during preperation The tip of the cannulas will be adjusted to be 1 mm shorter than the working length Calcium hydroxide Kalsin Aktug Tic BornovaIzmir Turkey paste is placed in the root canals after the preperation process and the tooth is temporarily closed with Cavit-G 3M ESPE Seefeld Germany And the patient will be given an appointment 2 weeks later When the patient comes to the second session appointment the temporary restoration will be removed and the calcium hydroxide paste from root canals will be removed Canals will be irrigated with 5 ml NaOCl 525 and 17 EDTA solution for the removal of calcium hydroxide Then canals will reshaped with ProTaperNext X3 DentsplyMaillefer Baillagues Switzerland And then again 5 ml NaOCl 525 and 17 EDTA solution will be used for irrigation to be ensured that calcium hydroxide is completely removed from the root canals For final irrigation respectively 5 ml NaOCl 525 solution 5 ml 17 EDTA solution and 525 NaOCl solution will be used According to NaOCl activation Group1 NaOCl ErCrYSSG will be activated by laser during the final irrigation Group2 control Routine final irrigation procedure will be done NaOCl will not be activated by any method teeth will be divided into two main groups n15
After final irrigation and activation procedure root canals will be dried with sterile paper points then all root canals will be obturated with sterile gutta-perchas and AH Plus root canal sealer Dentsply DeTrey Gmbh Konstanz Germany using the single-cone technique Teeth with completed root canal filling will be restored with composite filling material to ensure coronal sealing After the treatment the patients in both groups will be called for control at periodically 1st month - 3rd month and gingival crevicular fluid samples will be taken again with Periopaper Oraflow New York NY According to the results which is obtained with the ELISA test the change in the RANKL and OPG levels in the gingival crevicular fluid of the patients will be evaluated
Before taking a sample of gingival crevicular fluid the tooth will be washed with water dried and the plaque and deposits on it will be cleaned with cotton Then the tooth will be isolated with a cotton pellet and a suction and a Periopaper Oraflow New York NY will be placed 1-2 mm into the gingival sulcus until slight resistance is felt and a sample of gingival crevicular fluid will be taken after waiting for 30 seconds Specimens contaminated with blood or saliva will not be included in the study Then these samples will be stored at -80C The access cavity will be opened to the teeth under local anesthesia with a 2 milliliter Ultracain D-S Aventis The Netherlands The working length will be determined with a 15 K-files Mani Inc Tochigi Japan with the apex locator DentsplyMaillefer UK and radiographic imaging
The preperation of the root canals will be completed by ProTaperNext DentsplyMaillefer Baillagues Switzerland up to the X3 instrument as standard in each patient 2 ml of 525 NaOCl solution will be used at each file change during preperation During the irrigation process a 2 milliliter dental injector and a 27 gauge dental needle tip will be used during preperation The tip of the cannulas will be adjusted to be 1 mm shorter than the working length Calcium hydroxide Kalsin Aktug Tic BornovaIzmir Turkey paste is placed in the root canals after the preperation process and the tooth is temporarily closed with Cavit-G 3M ESPE Seefeld Germany And the patient will be given an appointment 2 weeks later When the patient comes to the second session appointment the temporary restoration will be removed and the calcium hydroxide paste from root canals will be removed Canals will be irrigated with 5 ml NaOCl 525 and 17 EDTA solution for the removal of calcium hydroxide Then canals will reshaped with ProTaperNext X3 DentsplyMaillefer Baillagues Switzerland And then again 5 ml NaOCl 525 and 17 EDTA solution will be used for irrigation to be ensured that calcium hydroxide is completely removed from the root canals For final irrigation respectively 5 ml NaOCl 525 solution 5 ml 17 EDTA solution and 525 NaOCl solution will be used According to NaOCl activation Group1 NaOCl ErCrYSSG will be activated by laser during the final irrigation Group2 control Routine final irrigation procedure will be done NaOCl will not be activated by any method teeth will be divided into two main groups n15
After final irrigation and activation procedure root canals will be dried with sterile paper points then all root canals will be obturated with sterile gutta-perchas and AH Plus root canal sealer Dentsply DeTrey Gmbh Konstanz Germany using the single-cone technique Teeth with completed root canal filling will be restored with composite filling material to ensure coronal sealing After the treatment the patients in both groups will be called for control at periodically 1st month - 3rd month and gingival crevicular fluid samples will be taken again with Periopaper Oraflow New York NY According to the results which is obtained with the ELISA test the change in the RANKL and OPG levels in the gingival crevicular fluid of the patients will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None