Pulp and Periapical Tissue DiseaseNCT07468643
Gingival Crevicular Fluid Biomarkers and Healing After Root Canal Treatment in Asymptomatic Apical Periodontitis
An observational study of Pulp and Periapical Tissue Disease, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp and Periapical Tissue Disease
- What is being tested?
- Primary Nonsurgical Root Canal Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers as Indicators of Periapical Healing Following Root Canal Treatment in Teeth With Apical Periodontitis: A Prospective Cohort Study
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.
Read the 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
- Pulp and Periapical Tissue Disease
- Being tested
- Primary Nonsurgical Root Canal Treatment
- Keywords
- gingival crevicular fluid, OPG, RANKL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Nonsurgical Root Canal TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Primary Nonsurgical Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Healing of Apical Periodontitis
Measured: 12 months after root canal treatment
Secondary outcomes (1)
Change in Gingival Crevicular Fluid biomarkers
Measured: Baseline, 3 months, 6 months ,and 12 months after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start2 May 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp and Periapical Tissue DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maha Adel, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468643
- Sponsor's protocol ID
- ENDOD-130-1-a
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers as Indicators of Periapical Healing Following Root Canal Treatment in Teeth With Apical Periodontitis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07468643
- Acronym / sponsor ID
- ENDOD-130-1-a
- Conditions
- Pulp and Periapical Tissue Disease
- Keywords
- gingival crevicular fluid, OPG, RANKL
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 2 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Apical Periodontitis Treated with Root Canal Treatment | – | Procedure: Primary Nonsurgical Root Canal TreatmentAdult 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary 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. | Procedure or surgery | Asymptomatic Apical Periodontitis Treated with Root Canal Treatment |
Primary outcome
Radiographic Healing of Apical Periodontitis
Time frame: 12 months after root canal treatment
1 secondary outcome
Change in Gingival Crevicular Fluid biomarkers
Time frame: Baseline, 3 months, 6 months ,and 12 months after root canal treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulp and Periapical Tissue Disease, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Healing of Apical Periodontitis (time frame: 12 months after root canal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.