Gingival Crevicular Fluid Biomarkers and Healing After Root Canal Treatment in Asymptomatic Apical Periodontitis

March 9, 2026 updated by: Maha Adel, Faculty of Dental Medicine for Girls

Biomarkers as Indicators of Periapical Healing Following Root Canal Treatment in Teeth With Apical Periodontitis: A Prospective Cohort Study

This prospective observational cohort study will evaluate whether changes in gingival crevicular fluid osteoprotegerin (OPG) , RANKL/OPG ratio ,IL10,IL8and CxCL10 after primary nonsurgical root canal treatment are associated with 12-month radiographic healing in teeth with asymptomatic apical periodontitis. Participants will undergo standardized treatment and follow-up with serial GCF sampling and standardized digital periapical radiography.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Apical periodontitis healing is evaluated by clinical and radiographic follow-up, but radiographic interpretation may remain uncertain during the healing period. Gingival crevicular fluid is a minimally invasive oral biofluid that may reflect local inflammatory and bone remodeling changes associated with apical disease and recovery after treatment. The study will enroll adult patients undergoing primary nonsurgical root canal treatment for asymptomatic apical periodontitis. GCF will be sampled at baseline, 3 months, 6 months, and 12 months. OPG, L10, IL8 , CxCL10and RANKL concentrations will be measured by ELISA and the RANKL/OPG ratio calculated. Standardized digital periapical radiographs will be obtained at baseline ,6 months, and 12 months. The primary analysis will assess whether early changes in GCF biomarkers are associated with 12-month radiographic healing, quantified by lesion-area reduction and periapical index change.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • ALazhar university - faculty of dental medicine for girls

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients presenting to a university endodontic clinic who require primary nonsurgical root canal treatment for permanent teeth diagnosed with asymptomatic apical periodontitis. Participants will be recruited from patients seeking routine endodontic care. Eligible teeth will present with pulp necrosis and a radiographically detectable periapical radiolucency on standardized digital periapical radiographs. Gingival crevicular fluid samples will be collected from the affected tooth before treatment and during follow-up visits to evaluate biomarker levels and their association with radiographic healing after root canal treatment.

Description

Inclusion Criteria:

Adults 18 -40 years .

Presence of one permanent tooth diagnosed with asymptomatic apical periodontitis.

Diagnosis confirmed by pulp necrosis or non-vital pulp and presence of a periapical radiolucency on digital periapical radiograph.

Tooth indicated for primary nonsurgical root canal treatment.

Tooth must be restorable and periodontally healthy.

Periapical lesion detectable radiographically and suitable for follow-up evaluation.

Participant able and willing to provide written informed consent.

Participant willing to attend follow-up visits during the study period.

Exclusion Criteria

Participants will be excluded if any of the following conditions are present:

Teeth previously treated with root canal treatment (retreatment cases).

Teeth with acute apical abscess, swelling, or sinus tract.

Teeth with combined endodontic-periodontal lesions.

Periodontal pockets >3 mm or evidence of active periodontal disease around the study tooth.

Teeth with vertical root fracture, root perforation, or severe root resorption.

Teeth with hopeless restorative or periodontal prognosis.

Patients with systemic diseases that may affect healing (e.g., uncontrolled diabetes, immunosuppression).

Pregnant or breastfeeding women.

Patients currently taking systemic antibiotics, corticosteroids, or anti-inflammatory medications within the last 2 weeks.

Current smokers or tobacco users.

Inability to attend scheduled follow-up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asymptomatic Apical Periodontitis Treated with Root Canal Treatment
Adult patients with teeth diagnosed with asymptomatic apical periodontitis undergoing standardized primary nonsurgical root canal treatment. Gingival crevicular fluid biomarkers will be collected at baseline and follow-up visits and correlated with radiographic healing assessed by digital periapical radiography.
Procedure: Primary Nonsurgical Root Canal Treatment
Standardized primary nonsurgical root canal treatment will be performed in teeth diagnosed with asymptomatic apical periodontitis under rubber dam isolation. The procedure includes access cavity preparation, working length determination, chemomechanical canal preparation, irrigation using sodium hypochlorite solution, obturation of the root canal system, and placement of a coronal restoration according to standard endodontic protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic Healing of Apical Periodontitis
Time Frame: 12 months after root canal treatment
12 months after root canal treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Gingival Crevicular Fluid biomarkers
Time Frame: Baseline, 3 months, 6 months ,and 12 months after root canal treatment
Baseline, 3 months, 6 months ,and 12 months after root canal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ENDOD-130-1-a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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