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NCT Number: NCT07468643

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ALazhar university - faculty of dental medicine for girls

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Radiographic Healing of Apical Periodontitis

    Time frame: 12 months after root canal treatment

Secondary outcomes

  1. Change in Gingival Crevicular Fluid biomarkers

    Time frame: Baseline, 3 months, 6 months ,and 12 months after root canal treatment

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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