Periapical PeriodontitisNCT05525013
Effect of Simvastatin Versus Calcium Hydroxide Intracanal Medications on Post-operative Pain and Interleukin 6 and 8
A study testing Simvastatin Powder and Calcium Hydroxide in people with Periapical Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing the effect of Simvastatin versus calcium hydroxide used as an intracanal medicament on Post-operative Pain and Total amount of IL-6 and IL-8 in Periapical Fluids of lower premolars in patients with Symptomatic Apical Periodontitis: Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Simvastatin Powder and Calcium Hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Jul 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Lower single rooted premolars:
- Presence of pain with percussion.
- Widening in the periodontal membrane space or with small sized periapical radiolucency.
- Diagnosed clinically with symptomatic apical periodontitis.
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
Who cannot join
- Medically compromised patients
- Pregnant women
- Patients who are allergic to non-steroidal anti-inflammatory drugs.
- Patients with two or more adjacent teeth requiring root canal therapy
- If analgesics or antibiotics have been administrated by the patient during the past two weeks preoperatively.
- Patients reporting bruxism or clenching.
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- Teeth associated with acute periapical abscess, swelling or a fistulous tract.
- Greater than grade I mobility or pocket depth greater than 5mm.
- Non restorable teeth.
- Immature teeth.
- Teeth with previous endodontic treatment.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Simvastatin Versus Calcium Hydroxide Used as Intracanal Medicaments on Post-operative Pain and Total Amount of IL-6 and IL-8 in Periapical Fluids in Patients With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
Comparing the effect of Simvastatin versus calcium hydroxide used as an intracanal medicament on Post-operative Pain and Total amount of IL-6 and IL-8 in Periapical Fluids of lower premolars in patients with Symptomatic Apical Periodontitis:
Read the detailed description
Lower premolars with symptomatic apical periodontitis will be selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using simvastatin or calcium hydroxide intracanal medication for 1 week. The endodontic treatment will be completed in two visits. Postoperative pain will be assessed using the Numerical Rating scale at 6, 12, 24, 48 hours post-instrumentation and at 6, 12, 24, 48 hours post-obturation. Periapical fluid sample will be collected immediately post-instrumentation and 1 week later pre-obturation. The periapical samples will be analyzed for total amounts of IL-6 and IL-8.
- Conditions
- Periapical Periodontitis
- Being tested
- Simvastatin Powder, Calcium Hydroxide
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin PowderDrug
Simvastatin gel placed as an intracanal medication
Calcium HydroxideDrug
Calcium hydroxide intracanal medication
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Simvastatin as an intracanal medication Receives: Drug: Simvastatin Powder |
| Calcium hydroxide | Active comparator | Calcium hydroxide intracanal medication Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain incidence and intensity assessed with numerical rating scale
0 (none) to 10 (severe) Numerical Pain Rating Scale
Measured: 6,12,24 and 48 hours post-instrumentation and 6,12,24 and 48 hours post-obturation
Secondary outcomes (1)
Total amount of IL-6 and IL-8 in periapical fluids
Absorbance using ELISA test in Pg/ml
Measured: Immediately post-instrumentation and pre-obturation (1 week post- instrumentation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Computerized random sequence will be generated using computer software (http://www.random.org/). The sequence generation will be done for the patients' numbers which results in a sequence of random numbers divided in two columns (A \& B), where one column assigned for the intervention groups and one for the control group and kept with the co- supervisor. The patients will be allocated into either of the two groups with allocation ratio 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Essam Othman Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525013
- Sponsor's protocol ID
- CEBD-CU-2022-8-30
- Status last verified
- Jun 2025
- First submitted
- 30 Aug 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan AA, Sun X, Hargreaves KM. Effect of calcium hydroxide on proinflammatory cytokines and neuropeptides. J Endod. 2008 Nov;34(11):1360-1363. doi: 10.1016/j.joen.2008.08.020. Epub 2008 Sep 17.
PubMed 18928847Sharma A, Sanjeev K, Selvanathan VMJ, Sekar M, Harikrishnan N. The evaluation of cytotoxicity and cytokine IL-6 production of root canal sealers with and without the incorporation of simvastatin: an invitro study. BMC Oral Health. 2022 Jan 11;22(1):6. doi: 10.1186/s12903-022-02039-y.
PubMed 35012572Essam Othman Alghidany M, Ahmed Morsy D, Shaker OG, Mohamed El Boghdadi R. Effect of simvastatin versus calcium hydroxide intracanal medications on postoperative pain and cytokine modulation in symptomatic apical periodontitis: a randomized controlled trial. BMC Oral Health. 2026 Sep 15;26(1):1751. doi: 10.1186/s12903-026-09793-3.
PubMed 42750035
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simvastatin Versus Calcium Hydroxide Used as Intracanal Medicaments on Post-operative Pain and Total Amount of IL-6 and IL-8 in Periapical Fluids in Patients With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05525013
- Acronym / sponsor ID
- CEBD-CU-2022-8-30
- Conditions
- Periapical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 1 Sep 2022 (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.
Comparing the effect of Simvastatin versus calcium hydroxide used as an intracanal medicament on Post-operative Pain and Total amount of IL-6 and IL-8 in Periapical Fluids of lower premolars in patients with Symptomatic Apical Periodontitis:
Detailed description
Lower premolars with symptomatic apical periodontitis will be selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using simvastatin or calcium hydroxide intracanal medication for 1 week. The endodontic treatment will be completed in two visits. Postoperative pain will be assessed using the Numerical Rating scale at 6, 12, 24, 48 hours post-instrumentation and at 6, 12, 24, 48 hours post-obturation. Periapical fluid sample will be collected immediately post-instrumentation and 1 week later pre-obturation. The periapical samples will be analyzed for total amounts of IL-6 and IL-8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Computerized random sequence will be generated using computer software (http://www.random.org/). The sequence generation will be done for the patients' numbers which results in a sequence of random numbers divided in two columns (A \& B), where one column assigned for the intervention groups and one for the control group and kept with the co- supervisor. The patients will be allocated into either of the two groups with allocation ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: Simvastatin PowderSimvastatin as an intracanal medication |
| Calcium hydroxide | Active comparator | Drug: Calcium HydroxideCalcium hydroxide intracanal medication |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Lower single rooted premolars:
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
Key exclusion criteria (12 listed)
- Medically compromised patients
- Pregnant women
- Patients who are allergic to non-steroidal anti-inflammatory drugs.
- Patients with two or more adjacent teeth requiring root canal therapy
- If analgesics or antibiotics have been administrated by the patient during the past two weeks preoperatively.
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 |
|---|---|---|
| Simvastatin PowderSimvastatin gel placed as an intracanal medication | Drug | Simvastatin |
| Calcium HydroxideCalcium hydroxide intracanal medication | Drug | Calcium hydroxide |
Primary outcome
Post operative pain incidence and intensity assessed with numerical rating scale
Time frame: 6,12,24 and 48 hours post-instrumentation and 6,12,24 and 48 hours post-obturation
0 (none) to 10 (severe) Numerical Pain Rating Scale
1 secondary outcome
Total amount of IL-6 and IL-8 in periapical fluids
Time frame: Immediately post-instrumentation and pre-obturation (1 week post- instrumentation)
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 13 Jun 2025.
- Background: PubMed 18928847Khan AA, Sun X, Hargreaves KM. Effect of calcium hydroxide on proinflammatory cytokines and neuropeptides. J Endod. 2008 Nov;34(11):1360-1363. doi: 10.1016/j.joen.2008.08.020. Epub 2008 Sep 17.
- Background: PubMed 35012572Sharma A, Sanjeev K, Selvanathan VMJ, Sekar M, Harikrishnan N. The evaluation of cytotoxicity and cytokine IL-6 production of root canal sealers with and without the incorporation of simvastatin: an invitro study. BMC Oral Health. 2022 Jan 11;22(1):6. doi: 10.1186/s12903-022-02039-y.
- Derived from this study: PubMed 42750035Essam Othman Alghidany M, Ahmed Morsy D, Shaker OG, Mohamed El Boghdadi R. Effect of simvastatin versus calcium hydroxide intracanal medications on postoperative pain and cytokine modulation in symptomatic apical periodontitis: a randomized controlled trial. BMC Oral Health. 2026 Sep 15;26(1):1751. doi: 10.1186/s12903-026-09793-3.
- 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?
A study testing Simvastatin Powder and Calcium Hydroxide in people with Periapical Periodontitis, run by Cairo University 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 7 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: finished, as of the sponsor's last update on 13 Jun 2025. 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?
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?
Post operative pain incidence and intensity assessed with numerical rating scale (time frame: 6,12,24 and 48 hours post-instrumentation and 6,12,24 and 48 hours post-obturation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525013, which also lists 3 linked publications.
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 13 Jun 2025.