- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05478811
Evaluation of RANKL/OPG Levels in Gingival Crevicular Fluid at 1st and 3rd Months of Activation of NaOCl With Er,Cr YSSG Laser in Root Canal Treatment
Evaluation of RANKL/OPG Levels in Gingival Crevicular Fluid at 1st and 3rd Months of Activation of NaOCl With Er,Cr YSSG Laser in Root Canal Treatment of Mandibular Molar Teeth With Periapical Lesions
Study Overview
Status
Conditions
Intervention / Treatment
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 G*Power 3.1 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 1.252193, alpha=0.05 and power=0.90. 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 -80°C. 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 5.25% 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 Bornova,Izmir, 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 5.25% 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 5.25% 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 %5,25 solution , 5 ml. % 17 EDTA solution and %5,25 NaOCl solution will be used. According to NaOCl activation (Group1: NaOCl, Er,Cr:YSSG 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 (n:15).
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Van, Turkey, 65000
- Yuzuncu Yıl University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy persons between the ages of 18 and 50 years
- Mandibular molar teeth that were diagnosed with periapical lesions
Exclusion Criteria:
- Pregnancy or lactation
- Patients who do not have periapical lesions,
- Teeth with immature/open apex
- A probing depth of more than 3 mm
- Bleeding during probing will not be included in the study group
- Teeth with root resorption
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Er,Cr:YSSG laser
NaOCl, Er,Cr:YSSG will be activated by laser during the final irrigation
|
NaOCl, Er,Cr:YSSG will be activated by laser during the final irrigatio
Routine final irrigation procedure will be done, NaOCl will not be activated by any method)
|
Active Comparator: Control
Routine final irrigation procedure will be done, NaOCl will not be activated by any method.
|
NaOCl, Er,Cr:YSSG will be activated by laser during the final irrigatio
Routine final irrigation procedure will be done, NaOCl will not be activated by any method)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RANKL/OPG levels
Time Frame: 3 months
|
RANKL/OPG levels in the gingival crevicular fluid
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/15.12.2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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