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. (RCT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp
• Intervention / Treatment: Drug: Calcium Hydroxide (Ca(OH)2); Drug: 1% melatonin gel

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Ibrahim Mekhimar; Phone Number: 00201101700576; Email: alaa.ibrahim@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: calcium hydroxide; Calcium Hydroxide (Metapaste. META BIOMED CO., LTD, Korea): It is a water-soluble, premixed	Drug: Calcium Hydroxide (Ca(OH)2); a water-soluble, premixed calcium hydroxide paste with barium sulfate, supplied in a 2.2g syringe
Experimental: 1% melatonin gel; 1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university	Drug: 1% melatonin gel; 1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	intraoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 22, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Calcium Compounds; Calcium Hydroxide
• Other Study ID Numbers: New Endo 3.3.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No