Pain Management
Conditions
Brief summary
This protocol presents a randomized clinical trial comparing Hyalone (hyaluronic acid) with calcium hydroxide as intracanal medicaments in mandibular first molars with necrotic pulp and symptomatic apical periodontitis. The study aims to determine whether Hyalone provides better postoperative pain reduction and periapical healing than calcium hydroxide.
Interventions
DRUGHyalone
Hyalone will be used as an intracanal medicament during two-appointment root canal treatment. The medicament will be placed in the root canals after biomechanical preparation and irrigation and maintained for 7 days before final obturation.
Calcium hydroxide will be used as an intracanal medicament during two-appointment root canal treatment. The medicament will be placed in the root canals after biomechanical preparation and maintained for 7 days before final obturation.
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* • Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II). * Age range is between 20 to 40 years. * Patients have restorable permanent mandibular first molars (mesial root type III and distal canal type III) that were diagnosed necrotic with symptomatic apical periodontitis with small to moderate periapical lesion less that 5 mm according to CBCT-PAI in highest diameter at any axis in CBCT). * Positive patient's acceptance for participating in the study. * Patients able to sign informed consent
Exclusion criteria
* • Medically compromised patients. * Pregnant or lactating females. * Psychologically disturbed patients. * Patients with a history of allergy to any medication used in the study were excluded. Teeth that have: * Periodontally affected with grade 2 or 3 mobility. * Not restorable teeth. * Abnormal anatomy and calcified canals. * Previous root canal treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-operative pain | 6 hours,12hours,24 hours, 72 hours & 1week | Postoperative pain will be assessed using the Modified Visual Analogue Scale (mVAS), an 11-point numeric scale with a minimum score of 0 and a maximum score of 10, accompanied by corresponding facial-expression icons at each level. Higher scores indicate worse pain: a score of 0 represents "no pain" and a score of 10 represents "the worst pain imaginable." Scores will be categorized as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10). Each participant will record pain intensity in a standardized pain diary at each designated time point following intracanal medicament placement. Mean pain scores will be compared between the calcium hydroxide (control) and Hyalone (intervention) groups at each time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| periapical healing | 6months & 12 months | Periapical healing will be assessed radiographically using cone-beam computed tomography (CBCT), evaluated in the axial, sagittal, and coronal planes with the mesial and distal roots scored separately. Healing status will be scored using the Cone-Beam Computed Tomography Periapical Index (CBCT-PAI), and follow-up scores will be compared with the baseline preoperative CBCT to determine change in periapical lesion size. Based on combined clinical and radiographic findings, each treated tooth will be classified as healed (no clinical signs or symptoms, with complete radiographic resolution of the periapical lesion or a CBCT-PAI score of 1 or 2), healing (no clinical signs or symptoms, with a reduction in lesion size and CBCT-PAI score compared with baseline), or diseased (persistent or new clinical signs or symptoms, or no reduction/an increase in lesion size or CBCT-PAI score). For statistical analysis, outcomes will be dichotomized: teeth classified as healed or healing will be conside |
| preapical healing | 6 month and 12 month | Periapical healing will be assessed radiographically using cone-beam computed tomography (CBCT), evaluated in the axial, sagittal, and coronal planes with the mesial and distal roots scored separately. Healing status will be scored using the Cone-Beam Computed Tomography Periapical Index (CBCT-PAI), and follow-up scores will be compared with the baseline preoperative CBCT to determine change in periapical lesion size. Based on combined clinical and radiographic findings, each treated tooth will be classified as healed (no clinical signs or symptoms, with complete radiographic resolution of the periapical lesion or a CBCT-PAI score of 1 or 2), healing (no clinical signs or symptoms, with a reduction in lesion size and CBCT-PAI score compared with baseline), or diseased (persistent or new clinical signs or symptoms, or no reduction/an increase in lesion size or CBCT-PAI score). For statistical analysis, outcomes will be dichotomized: teeth classified as healed or healing will be conside |
Countries
Egypt
Outcome results
None listed