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Not yet recruitingNCT07495605RCTUpdated Mar 27, 2026

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.

An interventional study of 1% melatonin gel and Calcium Hydroxide (Ca(OH)2) in Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp, sponsored by Cairo University. Not yet recruiting. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18-50 years old.
  2. Males and females.
  3. Healthy patients categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II), with no underlying allergies.
  4. Single-rooted mandibular premolar teeth, having single root canal: diagnosed clinically with pulp necrosis.
  5. Patients accepting to participate in the trial.
  6. Patients who can understand pain scale (Appendix I) and can sign the informed consent (Appendix II).

Exclusion criteria

Exclusion Criteria:

  1. Medically compromised patients having significant systemic disorders (ASA III or IV).
  2. Pregnant females.
  3. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
  4. Teeth with multiple canals.
  5. Teeth that show association with acute periapical abscess or swelling.
  6. Teeth with vital pulp.
  7. Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam.
  8. Immature teeth.
  9. Teeth with greater than grade I mobility or pocket depth greater than 4 mm.
  10. Teeth showing radiographic evidence of external or internal root resorption, vertical root fracture, perforation or calcification.
  11. Patients with two or more adjacent teeth requiring endodontic treatment.
  12. Patients reporting bruxism, clenching or TMJ problems.
  13. Teeth with previous endodontic treatment.
  14. Inability to perceive the given instructions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    calcium hydroxide

    Calcium Hydroxide (Metapaste. META BIOMED CO., LTD, Korea): It is a water-soluble, premixed

    Drug: Calcium Hydroxide (Ca(OH)2)

  • Experimental
    1% melatonin gel

    1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university

    Drug: 1% melatonin gel

Interventions

  • Drug1% melatonin gel

    1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university

  • DrugCalcium Hydroxide (Ca(OH)2)

    a water-soluble, premixed calcium hydroxide paste with barium sulfate, supplied in a 2.2g syringe

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 48 hours

Secondary outcomes

  1. 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)

    Time frame: intraoperative

  2. 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

    Time frame: intraoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07495605
Lead sponsor
Cairo University
Responsible party
Alaa Ibrahim Ibrahim Ghazy Mekhimar (Dr, Cairo University) — Principal investigator
First posted
Mar 27, 2026
Start date
Mar 22, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Alaa Ibrahim Mekhimar
Contact
alaa.ibrahim@dentistry.cu.edu.eg
00201101700576

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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