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

NCT07821866 | Active Not Recruiting Early Phase 1

• 1 other identifier: FUE.REC18/1-2026
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours,12hours,24 hours, 72 hours & 1week

Secondary Outcomes (2)

• periapical healing

  6months & 12 months

• preapical healing

  6 month and 12 month

Study Arms (2)

calcium hydroxide intracanal medication

ACTIVE COMPARATOR

Drug: Calcium Hydroxide (Ca(OH)2) Intracanal Medication

Hyalone Intracanal Medication

EXPERIMENTAL

Drug: Hyalone

Interventions

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.

Also known as: Intervention 1

Hyalone Intracanal Medication

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.

calcium hydroxide intracanal medication

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Faculty of Oral and Dental Medicine, Future University in Egypt

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduate student

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 16, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-01

Locations

EG (1)