NCT05478811

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

July 25, 2022

Last Update Submit

July 28, 2022

Conditions

Keywords

Gingival cervicular fluidiRANKLOPG

Outcome Measures

Primary Outcomes (1)

  • RANKL/OPG levels

    RANKL/OPG levels in the gingival crevicular fluid

    3 months

Study Arms (2)

Er,Cr:YSSG laser

ACTIVE COMPARATOR

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

Device: Er,Cr:YSSG laserDevice: Control

Control

ACTIVE COMPARATOR

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

Device: Er,Cr:YSSG laserDevice: Control

Interventions

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

ControlEr,Cr:YSSG laser
ControlDEVICE

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

ControlEr,Cr:YSSG laser

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yıl University

Van, 65000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30892373BACKGROUND
  • 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. doi: 10.1038/s41598-025-33466-w. Online ahead of print.

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 28, 2022

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations