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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
NA trial testing Er,Cr:YSSG laser in Periapical Diseases in 30 participants. Status unknown.
1 October 2022
Quick facts
| Lead sponsor | Yuzuncu Yil University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2022 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Er,Cr:YSSG laser
- Control
Conditions studied
- Periapical Diseases — all drugs for Periapical Diseases →
Sponsor
Yuzuncu Yil University
Who can join
Adults 18 to 50, any sex, with Periapical Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 Er,Cr 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 differentiation.When the investigators look at the studies in the literature, there are many studies showing that the level of RANKL/OPG 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 RANKL/OPG 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 Er,Cr YSSG laser on the RANKL/OPG levels in the gingival crevicular fluid in the 1-3 month bone healing period after root canal treatment in lesioned teeth.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effect of Er, Cr: YSGG laser-activated final irrigation on gingival crevicular fluid RANKL/OPG levels.
Evrendilek F, Özlek E, Meydan İ. · · 2025 · PMID 41436629 · DOI 10.1038/s41598-025-33466-w
Verify or expand the search:
- PubMed search for NCT05478811
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05478811 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yuzuncu Yil University
- Last refreshed: 2 August 2022
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