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Active, not recruiting

NCT Number: NCT07821866

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Oral and Dental Medicine, Future University in Egypt

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyalone

Drug

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.

Other names: Intervention 1

Calcium Hydroxide (Ca(OH)2) Intracanal Medication

Drug

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.

Primary outcomes

  1. post-operative pain

    Time frame: 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 outcomes

  1. periapical healing

    Time frame: 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

  2. preapical healing

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Comparative Evaluation of Hyalone and Calcium Hydroxide on Post-Operative Pain and Periapical Healing in Mandibular Molars Teeth With Necrotic Pulp and Symptomatic Apical Periodontitis .

Acronym: HCPH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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