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Active Not RecruitingNCT07468643

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
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Faculty of Dental Medicine for Girls · Other Government
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPrimary Nonsurgical Root Canal TreatmentStandardized 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.

Timeline

Start date
2025-05-02
Primary completion
2026-05-01
Completion
2026-05-01
First posted
2026-03-12
Last updated
2026-03-12

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07468643. Inclusion in this directory is not an endorsement.