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

NCT07468643 | Active Not Recruiting

• 1 other identifier: ENDOD-130-1-a
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp and Periapical Tissue Disease

Keywords

gingival crevicular fluid; OPG; RANKL

Outcome Measures

Primary Outcomes (1)

• Radiographic Healing of Apical Periodontitis

  12 months after root canal treatment

Secondary Outcomes (1)

• Change in Gingival Crevicular Fluid biomarkers

  Baseline, 3 months, 6 months ,and 12 months after root canal treatment

Study Arms (1)

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

Interventions

Primary Nonsurgical Root Canal Treatment PROCEDURE

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.

Asymptomatic Apical Periodontitis Treated with Root Canal Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

ALazhar university - faculty of dental medicine for girls

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

gingival crevicular fluid

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Endodontics

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: May 2, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)