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

ConditionIrreversible Pulpitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorCairo University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulpectomy using 2.5% Calcium Hypochlorite root canal irrigant.

    Procedure/Surgery

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

  • Pulpectomy using Saline as root canal irrigant

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: • Pulpectomy using Calcium Hypochlorite 2.5% as root canal irrigantExperimental treatment 1 intervention
Group B: • Pulpectomy using Saline as root canal irrigantActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absence of post-operative pain.

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

Time frame
1-week changes from baseline pulp condition

Secondary outcomes

1

Absence of Swelling/Sinus or Fistula.

Visual clinical examination. Outcome measuring unit: Binary (yes/no)

Time frame
at 3,6,9 and 12 months changes from the baseline pulp condition.
2

Absence of Pain to percussion

Percussion test using the back of a dental mirror. Outcome measuring unit :Binary (yes/no)

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

Pathologic mobility

Mobility test (pressure using the end of two dental mirrors). Outcome measuring unit :Binary (yes/no)

Time frame
at 3,6,9 and 12 months changes from the baseline pulp condition.
4

Absence of furcation or periapical radiolucency.

Intraoral digital periapical X-ray. Outcome measuring unit :Binary (present/absent)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: