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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 1% melatonin gel, Calcium Hydroxide (Ca(OH)2).
- Who it may be relevant to
- Registry conditions: Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp. Basic parameters: 21 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug 1% melatonin gel
1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university - Drug Calcium Hydroxide (Ca(OH)2)
a water-soluble, premixed calcium hydroxide paste with barium sulfate, supplied in a 2.2g syringe
Primary outcome measures
- Intensity of postoperative pain [Time frame: up to 48 hours]
Secondary outcome measures (2)
- Bacterial load reduction [Time frame: intraoperative]
- Periapical MMP-9 level [Time frame: intraoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07495605 · New Endo 3.3.3