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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07468643
Enrollment
60
Registered
2026-03-12
Start date
2025-05-02
Completion date
2026-05-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp and Periapical Tissue Disease

Keywords

gingival crevicular fluid, OPG, RANKL

Brief summary

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.

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.

Interventions

PROCEDUREPrimary 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.

Sponsors

Faculty of Dental Medicine for Girls
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Radiographic Healing of Apical Periodontitis12 months after root canal treatment

Secondary

MeasureTime frame
Change in Gingival Crevicular Fluid biomarkersBaseline, 3 months, 6 months ,and 12 months after root canal treatment

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026