Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp
Conditions
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.
Interventions
DRUG1% melatonin gel
1% melatonin gel: was prepared in the Drug Manufacture Unit, Faculty of Pharmacy, Cairo university
a water-soluble, premixed calcium hydroxide paste with barium sulfate, supplied in a 2.2g syringe
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of postoperative pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Bacterial load reduction | 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) |
| Periapical MMP-9 level | 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 |
Contacts
CONTACTAlaa Ibrahim Mekhimar
Outcome results
None listed