Gingival Crevicular Fluid Biomarkers and Healing After Root Canal Treatment in Asymptomatic Apica… (NCT07468643) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Gingival Crevicular Fluid Biomarkers and Healing After Root Canal Treatment in Asymptomatic Apical Periodontitis
Egypt60 participantsStarted 2025-05-02
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.