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NCT Number: NCT07495605

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.

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

1% melatonin gel

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Bacterial load reduction

    Time frame: intraoperative

    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)

  2. Periapical MMP-9 level

    Time frame: intraoperative

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Ibrahim Mekhimar

CONTACT

[email protected]

00201101700576

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.