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.

NCT07495605 | Not Yet Recruiting

• 1 other identifier: New Endo 3.3.3
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

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

  up to 48 hours

Secondary Outcomes (2)

• Bacterial load reduction

  intraoperative

• Periapical MMP-9 level

  intraoperative

Study Arms (2)

calcium hydroxide

ACTIVE COMPARATOR

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

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

Drug: 1% melatonin gel

Interventions

1% melatonin gel DRUG

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

1% melatonin gel

Calcium Hydroxide (Ca(OH)2) DRUG

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

calcium hydroxide

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Central Study Contacts

Alaa Ibrahim Mekhimar

CONTACT

00201101700576; alaa.ibrahim@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 27, 2026
• Study Start: March 22, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03