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Periapical DiseasesNCT05478811

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

A study testing Er,Cr:YSSG laser in people with Periapical Diseases, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Periapical Diseases
What is being tested?
Er,Cr:YSSG laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2022to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy persons between the ages of 18 and 50 years
  • Mandibular molar teeth that were diagnosed with periapical lesions

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Yuzuncu Yıl University

    Van, 65000

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Read the 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.

Being tested
Er,Cr:YSSG laser, Control
Keywords
Gingival cervicular fluidi, RANKL, OPG
Medical subject headings
Periapical Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Er,Cr:YSSG laserDevice

    NaOCl, Er,Cr:YSSG will be activated by laser during the final irrigatio

  • ControlDevice

    Routine final irrigation procedure will be done, NaOCl will not be activated by any method)

Study groups in NCT05478811
Study groupRoleWhat they receive
Er,Cr:YSSG laserActive comparatorNaOCl, Er,Cr:YSSG will be activated by laser during the final irrigation
Receives: Device: Er,Cr:YSSG laser; Device: Control
ControlActive comparatorRoutine final irrigation procedure will be done, NaOCl will not be activated by any method.
Receives: Device: Er,Cr:YSSG laser; Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RANKL/OPG levels

    RANKL/OPG levels in the gingival crevicular fluid

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start1 Jan 2022
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478811
Sponsor's protocol ID
10/15.12.2021
Status last verified
Jul 2022
First submitted
25 Jul 2022
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Arslan H, Koseoglu S, Doganay Yildiz E, Arabaci T, Savran L, Yildiz DA, Veyisoglu G. Effect of intracanal diode laser application and low-level laser therapy on CGRP change. Braz Oral Res. 2019 Mar 18;32:e125. doi: 10.1590/1807-3107bor-2018.vol32.0125.

    PubMed 30892373
  • Evrendilek F, Ozlek E, Meydan I. Effect of Er, Cr: YSGG laser-activated final irrigation on gingival crevicular fluid RANKL/OPG levels. Sci Rep. 2025 Dec 23;16(1):3430. doi: 10.1038/s41598-025-33466-w.

    PubMed 41436629

Questions about this trial

What is this clinical trial studying?

A study testing Er,Cr:YSSG laser in people with Periapical Diseases, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RANKL/OPG levels (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478811, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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