NCT07821866 - Comparing the Effectiveness of Hyalone and Calcium Hydroxide in Reducing Post-operative Pain and Promoting Periapical Healing. | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

24

Conditions

Pain Management

Interventions

HyaloneDRUG

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 (Ca(OH)2) Intracanal MedicationDRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Oral and Dental Medicine, Future University in Egypt

Cairo, Egypt

Outcomes

Primary Outcomes

post-operative pain

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.

Time frame: 6 hours,12hours,24 hours, 72 hours & 1week

Secondary Outcomes

periapical healing

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

Time frame: 6months & 12 months

preapical healing

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