Gingival Crevicular Fluid Biomarkers and Healing After Ro... | NCT07468643

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

NCT07468643

Sponsor

Faculty of Dental Medicine for Girls

Status

Active, not recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Pulp and Periapical Tissue Disease

Interventions

Primary Nonsurgical Root Canal Treatment

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2025Actual

Primary Completion Date

May 2026Estimated

Completion Date

May 2026Estimated

First Submitted Date

Mar 9, 2026

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 12, 2026Actual

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Radiographic Healing of Apical Periodontitis		12 months after root canal treatment

Measure	Description	Time Frame
Change in Gingival Crevicular Fluid biomarkers		Baseline, 3 months, 6 months ,and 12 months after root canal treatment

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample