Endodontic DiseasePhase 2/3NCT06207253
The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament
A Phase 2/3 study testing Diclofenac Sodium and Calcium hydroxide in people with Endodontic Disease and Pulp Disease, Dental, run by British University In Egypt at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Pulp Disease, Dental, Intracanal Medication
- What is being tested?
- Diclofenac Sodium and Calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2025to Dec 2025
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with teeth diagnosed with apical periodontitis
- Periapical Index (PAI) ≥ 2
- The teeth are restorable
Who cannot join
- Teeth with immature roots
- Non restorable teeth
- Medically compromised patients with systemic complication that would alter the treatment.
- Teeth with internal/external root resorption
- Patient with an allergy to diclofenac sodium
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
British university in Egypt
Cairo
Summer M Elsayed, Bachelor, 01000095124, pg.summer92140015@bue.edu.eg
About this study
Official title: The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial
The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis.
The main question[s] it aims to answer are:
- Will the diclofenac sodium (NSAIDs) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? Participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.
Read the detailed description
The aim of the present study is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. The evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having PAI score ≥ 2.
- Being tested
- Diclofenac Sodium, Calcium hydroxide
- Keywords
- Sodium diclofenac, Intracanal medication, Calcium hydroxide, Apical periodontitis
- Medical subject headings
- Dental Pulp Diseases, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
Calcium hydroxideDrug
placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
| Study group | Role | What they receive |
|---|---|---|
| High concentration of diclofenac sodium | Experimental | High concentration of diclofenac sodium mixed with saline Receives: Drug: Diclofenac Sodium |
| Low concentration of diclofenac sodium | Active comparator | Low concentration of diclofenac sodium mixed with saline Receives: Drug: Diclofenac Sodium |
| Calcium hydroxide | Active comparator | Calcium hydroxide paste form Receives: Drug: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial count
Variation in bacterial count in high concentration of Diclofenac Sodium group compared by group of low concentration of Diclofenac Sodium group and calcium hydroxide group.
Measured: On the seventh day from of intracanal medication placement appointment
Secondary outcomes (3)
Periapical healing
Change in the size of periapical lesion (according to Periapical index scale). The participants will be recalled after at least 6 months, and radiographic examination of the treated tooth will be performed. Preoperative and recall radiographs of teeth will be each assigned a Periapical index score by 2 blinded, independent, and calibrated examiners according to periapical index score (PAI):
PAI 1: Normal periapical structure. PAI 2: Bone structural changes indicating but not pathognomonic for apical periodontitis.
PAI 3: Bone structural changes with some mineral loss characteristic for apical periodontitis.
PAI 4: Well-defined apical radiolucency. PAI 5: Radiolucency with radiating expansion of bone structural changes.
Measured: participants will be recalled after 6 months from the obturation for radiographic examination.
incidence and intensity of pain
Patient will receive visual analogue scale (VAS) that will include a 10 cm line in which number 0 will correspond to no pain and number 10 will indicate unacceptable pain. Evaluation of intensity and incidence of pain, will be assessed each day for the following first three days after intracanal placement appointment (after 24 hours, 48 hours and 72 hours).
Measured: Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale
Incidence of flare-ups
Flare-up will be defined to patients as the development of swelling after treatment and will be represented by "Yes" (flare-up) or "No" (no flare-up). It will be recorded on chart that will given to the patients after the initial treatment.
Measured: Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study startNov 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Summer Elsayed, British University In Egypt
- Investigators
- Shehab Eldin M Saber, doctoral, Study director, british university in Egypt- dentistry collage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207253
- Sponsor's protocol ID
- 23-039
- Status last verified
- May 2025
- First submitted
- 14 Dec 2023
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament During Root Canal Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06207253
- Acronym / sponsor ID
- 23-039
- Keywords
- Sodium diclofenac, Intracanal medication, Calcium hydroxide, Apical periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Jan 2024 (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.
The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis.
The main question[s] it aims to answer are:
- Will the diclofenac sodium (NSAIDs) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? Participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.
Detailed description
The aim of the present study is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. The evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having PAI score ≥ 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High concentration of diclofenac sodium | Experimental | Drug: Diclofenac SodiumHigh concentration of diclofenac sodium mixed with saline |
| Low concentration of diclofenac sodium | Active comparator | Drug: Diclofenac SodiumLow concentration of diclofenac sodium mixed with saline |
| Calcium hydroxide | Active comparator | Drug: Calcium hydroxideCalcium hydroxide paste form |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with teeth diagnosed with apical periodontitis
- Periapical Index (PAI) ≥ 2
- The teeth are restorable
Key exclusion criteria (5 listed)
- Teeth with immature roots
- Non restorable teeth
- Medically compromised patients with systemic complication that would alter the treatment.
- Teeth with internal/external root resorption
- Patient with an allergy to diclofenac sodium
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 |
|---|---|---|
| Diclofenac Sodiumplacement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week. | Drug | High concentration of diclofenac sodium, Low concentration of diclofenac sodium |
| Calcium hydroxideplacement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week. | Drug | Calcium hydroxide |
Primary outcome
Bacterial count
Time frame: On the seventh day from of intracanal medication placement appointment
Variation in bacterial count in high concentration of Diclofenac Sodium group compared by group of low concentration of Diclofenac Sodium group and calcium hydroxide group.
3 secondary outcomes
Periapical healing
Time frame: participants will be recalled after 6 months from the obturation for radiographic examination.
incidence and intensity of pain
Time frame: Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale
Incidence of flare-ups
Time frame: Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days).
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 30 May 2025.
- 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.
Shehab Eldin M Saber, doctoral study director
british university in Egypt- dentistry collage
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diclofenac Sodium and Calcium hydroxide in people with Endodontic Disease and Pulp Disease, Dental, run by British University In Egypt 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 May 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Summer M Elsayed, Bachelor (01000095124, pg.summer92140015@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial count (time frame: On the seventh day from of intracanal medication placement appointment). 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 30 May 2025.