Clinical and Radiographic Evaluation of Calcium Hypochlorite Versus Saline As Root Canal Irrigants in Pulpectomy of Primary Molars: a Randomized Clinical Trial

NCT06748781 | Not Yet Recruiting

• 1 other identifier: Ca(OCl)2 Irrigation
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical and radiographic success of Calcium Hypochlorite versus Saline as root canal irrigants in pulpectomy of primary molars. The research question it aims to answer is: In pulpectomy of primary molars will the use of calcium hypochlorite as root canal irrigant result in superior clinical and radiographic success to saline?

Conditions

Irreversible Pulpitis

Keywords

calcium hypochlorite; irrigation; saline; irreversible pulpitis; calcium hydroxide with iodoform; primary molars; post operative pain

Outcome Measures

Primary Outcomes (1)

• Absence of post-operative pain.

  Asking the patient and/or guardian. Outcome measuring unit: Binary (Yes/No)

  1-week changes from baseline pulp condition

Secondary Outcomes (6)

• Absence of Swelling/Sinus or Fistula.

  at 3,6,9 and 12 months changes from the baseline pulp condition.

• Absence of Pain to percussion

  at 3,6,9 and 12 months changes from the baseline pulp condition.

• Pathologic mobility

  at 3,6,9 and 12 months changes from the baseline pulp condition.

• Absence of furcation or periapical radiolucency.

  at 6 and 12 months changes from the baseline pulp condition.

• Absence of external or internal root resorption.

  at 6 and 12 months changes from the baseline pulp condition.

Study Arms (2)

• Pulpectomy using Calcium Hypochlorite 2.5% as root canal irrigant

EXPERIMENTAL

Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant

Procedure: Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant.

• Pulpectomy using Saline as root canal irrigant

ACTIVE COMPARATOR

Pulpectomy using Saline as root canal irrigant.

Procedure: Pulpectomy using Saline as root canal irrigant

Interventions

Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant. PROCEDURE

2.5% Calcium Hypochlorite used as root canal irrigant during the pulpectomy procedure in mandibular primary molars.

Also known as: 2.5% Ca(OCl)2 Pulpectomy

• Pulpectomy using Calcium Hypochlorite 2.5% as root canal irrigant

Pulpectomy using Saline as root canal irrigant PROCEDURE

Saline used as root canal irrigant during the pulpectomy procedure in mandibular primary molars.

Also known as: Saline Pulpectomy

• Pulpectomy using Saline as root canal irrigant

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical Criteria:
• Children aged between 4 years and 7 years.
• Mandibular primary molars with deep caries lesion involving pulp.
• Mandibular primary molars that exhibit symptoms of irreversible pulpitis.
• Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
• No history of swelling, fistula or sinus tract related to the offending molar.
• Radiographic criteria:
• No sign of radiolucency in periapical or furcation area.
• No widening of PDL space or loss of lamina dura continuity.
• No evidence of internal/external pathologic root resorption.

You may not qualify if:

• Uncooperative children to avoid time waste and attrition bias.
• Children with systemic disease as some systemic diseases may have effect on the outcome (Segura-Egea et al., 2023).
• Lack of informed consent by the child patient's parent to be approved ethically.
• Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
• Refusal of participation as the parent of child has the authority of participation.
• Teeth near exfoliation time showing root resorption.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Educational Dental Hospital

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Root Canal Irrigants

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Dental Disinfectants; Disinfectants; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Yasmine Abdo Helmy ElAssar, BDS

CONTACT

0201023040204; yasmine.elasser@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yasmine Abdo Helmy ElAssar

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

EG (1)