Periapical Periodontitis(SCIP)NCT07704398
Effect of Corticosteroid Injection in Symptomatic Pulpitis Cases
A study testing Corticosteroid and Standard endodontic treatment in people with Periapical Periodontitis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial compared standard single-visit root canal treatment with adjunctive submucosal betamethasone and gentamicin in 100 patients with symptomatic irreversible pulpitis, assessing postoperative pain and inflammatory biomarkers (IL-1β, MMP-9, and RANKL). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Corticosteroid and Standard endodontic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2023to 23 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with symptomatic irreversible pulpitis
- Presence of spontaneous pain or pain persisting after removal of the stimulus
- Teeth indicated for endodontic treatment
- Systemically healthy individuals
- Patients able to read and sign the informed consent form
- Patients able to complete postoperative pain assessment forms
- Patients able to attend the 4-day follow-up visit
Who cannot join
- Individuals with systemic disease or immunosuppression
- Patients with contraindications to corticosteroid or gentamicin use
- Pregnant or breastfeeding individuals
- Recent use of antibiotics, analgesics, or anti-inflammatory drugs
- Presence of advanced periodontal disease in the affected tooth
- Presence of acute periapical or periodontal abscess
- Teeth with previous endodontic treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yelda Erdem Hepşenoğlu
Istanbul, Atakent Mahallesi
About this study
Official title: Effect of Submucosal Corticosteroid Injection on Inflammatory Biomarkers and Postoperative Pain in Patients With Symptomatic Pulpitis
This randomized clinical trial compared standard single-visit root canal treatment with adjunctive submucosal betamethasone and gentamicin in 100 patients with symptomatic irreversible pulpitis, assessing postoperative pain and inflammatory biomarkers (IL-1β, MMP-9, and RANKL).
Read the detailed description
This study was designed as a prospective, randomized controlled clinical trial. A total of 100 patients with a VAS pain score ≥7 and SIP in posterior teeth were included. Participants were randomly assigned into two groups: a standard root canal treatment group (n = 40) and an adjunctive treatment group receiving submucosal betamethasone and gentamicin (n = 60). In all cases, conventional single-visit root canal treatment was performed. Gingival crevicular fluid (GCF) samples were collected preoperatively and on postoperative day 3, and VAS scores were recorded at the same time points. Levels of IL-1β, MMP-9, and RANKL in GCF samples were quantified using enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Periapical Periodontitis
- Being tested
- Corticosteroid, Standard endodontic treatment
- Keywords
- Corticosteroid, Anesthesia, apical periodontitis, Root canal treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
One hundred patients were randomly assigned to either the standard treatment group receiving conventional root canal treatment (control, n = 40) or the adjunctive treatment group receiving conventional root canal treatment combined with submucosal betamethasone and gentamicin injection (n = 60) by the Research Randomizer programme (accessed at www.randomizer.org).
Standard endodontic treatmentOther
standard treatment group receiving conventional root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Patients in this group will undergo traditional root canal treatment under local anesthesia. Receives: Other: Standard endodontic treatment |
| adjunctive treatment group | Experimental | Patients in this group will receive submucosal injections following local anesthesia:
* Betamethasone
* Gentamicin
Then, root canal treatment will be performed in the same way as the control group. Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Crevicular Fluid Matrix Metalloproteinase-9 (MMP-9) Concentration
MMP-9 levels in gingival crevicular fluid will be quantified using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline and post-treatment day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start23 Oct 2023
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda Ersahan, DDS, PhD, Istanbul Medipol University Hospital
- Investigators
- Seyda Ersahan, Assoc.Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704398
- Sponsor's protocol ID
- E-10840098-772.02-6287
- Acronym
- (SCIP)
- Status last verified
- Jul 2026
- First submitted
- 11 May 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Submucosal Corticosteroid Injection on Inflammatory Biomarkers and Postoperative Pain in Patients With Symptomatic Pulpitis
- ClinicalTrials.gov ID
- NCT07704398
- Acronym / sponsor ID
- (SCIP) / E-10840098-772.02-6287
- Conditions
- Periapical Periodontitis
- Keywords
- Corticosteroid, Anesthesia, apical periodontitis, Root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 15 Jul 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 randomized clinical trial compared standard single-visit root canal treatment with adjunctive submucosal betamethasone and gentamicin in 100 patients with symptomatic irreversible pulpitis, assessing postoperative pain and inflammatory biomarkers (IL-1β, MMP-9, and RANKL).
Detailed description
This study was designed as a prospective, randomized controlled clinical trial. A total of 100 patients with a VAS pain score ≥7 and SIP in posterior teeth were included. Participants were randomly assigned into two groups: a standard root canal treatment group (n = 40) and an adjunctive treatment group receiving submucosal betamethasone and gentamicin (n = 60). In all cases, conventional single-visit root canal treatment was performed. Gingival crevicular fluid (GCF) samples were collected preoperatively and on postoperative day 3, and VAS scores were recorded at the same time points. Levels of IL-1β, MMP-9, and RANKL in GCF samples were quantified using enzyme-linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Standard endodontic treatmentPatients in this group will undergo traditional root canal treatment under local anesthesia. |
| adjunctive treatment group | Experimental | Drug: CorticosteroidPatients in this group will receive submucosal injections following local anesthesia: * Betamethasone * Gentamicin Then, root canal treatment will be performed in the same way as the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with symptomatic irreversible pulpitis
- Presence of spontaneous pain or pain persisting after removal of the stimulus
- Teeth indicated for endodontic treatment
- Systemically healthy individuals
- Patients able to read and sign the informed consent form
Key exclusion criteria (7 listed)
- Individuals with systemic disease or immunosuppression
- Patients with contraindications to corticosteroid or gentamicin use
- Pregnant or breastfeeding individuals
- Recent use of antibiotics, analgesics, or anti-inflammatory drugs
- Presence of advanced periodontal disease in the affected tooth
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 |
|---|---|---|
| CorticosteroidOne hundred patients were randomly assigned to either the standard treatment group receiving conventional root canal treatment (control, n = 40) or the adjunctive treatment group receiving conventional root canal treatment combined with submucosal betamethasone and gentamicin injection (n = 60) by the Research Randomizer programme (accessed at www.randomizer.org). | Drug | adjunctive treatment group |
| Standard endodontic treatmentstandard treatment group receiving conventional root canal treatment | Other | Control Group |
Primary outcome
Gingival Crevicular Fluid Matrix Metalloproteinase-9 (MMP-9) Concentration
Time frame: Baseline and post-treatment day 3
MMP-9 levels in gingival crevicular fluid will be quantified using enzyme-linked immunosorbent assay (ELISA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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.
Seyda Ersahan, Assoc.Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid and Standard endodontic treatment in people with Periapical Periodontitis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 15 Jul 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gingival Crevicular Fluid Matrix Metalloproteinase-9 (MMP-9) Concentration (time frame: Baseline and post-treatment day 3). 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 15 Jul 2026.