Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic PulpRCTNCT07495605
Effect of 1% Melatonin Gel Versus Calcium Hydroxide as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp.
A study testing 1% melatonin gel and Calcium Hydroxide (Ca(OH)2) in people with Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp, run by Cairo University.
Trial summary
To compare the effect of 1% melatonin gel versus calcium hydroxide as intra canal medication in necrotic mandibular premolars on: Intensity of postoperative pain. Bacterial load reduction. Periapical (MMP-9) level. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp
- What is being tested?
- 1% melatonin gel and Calcium Hydroxide (Ca(OH)2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2026to Dec 2027
- Phase
- Interventional
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-50 years old.
- Males and females.
- Healthy patients categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II), with no underlying allergies.
- Single-rooted mandibular premolar teeth, having single root canal: diagnosed clinically with pulp necrosis.
- Patients accepting to participate in the trial.
- Patients who can understand pain scale (Appendix I) and can sign the informed consent (Appendix II).
Who cannot join
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- Pregnant females.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- Teeth with multiple canals.
- Teeth that show association with acute periapical abscess or swelling.
- Teeth with vital pulp.
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- Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam.
- Immature teeth.
- Teeth with greater than grade I mobility or pocket depth greater than 4 mm.
- Teeth showing radiographic evidence of external or internal root resorption, vertical root fracture, perforation or calcification.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Patients reporting bruxism, clenching or TMJ problems.
- Teeth with previous endodontic treatment.
- Inability to perceive the given instructions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of 1% Melatonin Gel Versus Calcium Hydroxide as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial
To compare the effect of 1% melatonin gel versus calcium hydroxide as intra canal medication in necrotic mandibular premolars on:
- Intensity of postoperative pain.
- Bacterial load reduction.
- Periapical (MMP-9) level.
- Being tested
- 1% melatonin gel, Calcium Hydroxide (Ca(OH)2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% melatonin gelDrug
1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university
Calcium Hydroxide (Ca(OH)2)Drug
a water-soluble, premixed calcium hydroxide paste with barium sulfate, supplied in a 2.2g syringe
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide | Active comparator | Calcium Hydroxide (Metapaste. META BIOMED CO., LTD, Korea): It is a water-soluble, premixed Receives: Drug: Calcium Hydroxide (Ca(OH)2) |
| 1% melatonin gel | Experimental | 1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university Receives: Drug: 1% melatonin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain
Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation
Measured: up to 48 hours
Secondary outcomes (2)
Bacterial load reduction
Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation and removal of the placed intracanal medicament at 1 week (CFU/ml)
Measured: intraoperative
Periapical MMP-9 level
Periapical MMP-9 level will be determined in the first visit post-instrumentation (PS-1) and in the second visit pre-obturation (after intracanal medicament removal at 1 week) (PS-2) by ELISA
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start22 Mar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic PulpStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ibrahim Ibrahim Ghazy Mekhimar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495605
- Sponsor's protocol ID
- New Endo 3.3.3
- Acronym
- RCT
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 1% Melatonin Gel Versus Calcium Hydroxide as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07495605
- Acronym / sponsor ID
- RCT / New Endo 3.3.3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 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.
To compare the effect of 1% melatonin gel versus calcium hydroxide as intra canal medication in necrotic mandibular premolars on:
- Intensity of postoperative pain.
- Bacterial load reduction.
- Periapical (MMP-9) level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide | Active comparator | Drug: Calcium Hydroxide (Ca(OH)2)Calcium Hydroxide (Metapaste. META BIOMED CO., LTD, Korea): It is a water-soluble, premixed |
| 1% melatonin gel | Experimental | Drug: 1% melatonin gel1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-50 years old.
- Males and females.
- Healthy patients categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II), with no underlying allergies.
- Single-rooted mandibular premolar teeth, having single root canal: diagnosed clinically with pulp necrosis.
- Patients accepting to participate in the trial.
Key exclusion criteria (14 listed)
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- Pregnant females.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- Teeth with multiple canals.
- Teeth that show association with acute periapical abscess or swelling.
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 |
|---|---|---|
| 1% melatonin gel1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university | Drug | 1% melatonin gel |
| Calcium Hydroxide (Ca(OH)2)a water-soluble, premixed calcium hydroxide paste with barium sulfate, supplied in a 2.2g syringe | Drug | calcium hydroxide |
Primary outcome
Intensity of postoperative pain
Time frame: up to 48 hours
Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation
2 secondary outcomes
Bacterial load reduction
Time frame: intraoperative
Periapical MMP-9 level
Time frame: intraoperative
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 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing 1% melatonin gel and Calcium Hydroxide (Ca(OH)2) in people with Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp, run by Cairo University.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Alaa Ibrahim Mekhimar (00201101700576, alaa.ibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of postoperative pain (time frame: up to 48 hours). 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 27 Mar 2026.