Evaluation of the effect of cryotherapy after injection, on success rate of inferior alveolar nerve block anesthesia in the treatment of primary molars with irreversible pulpitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140601017935N9

Enrollment

Registered

2025-12-06

Start date

2025-12-21

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with irreversible pulpitis in a mandibular primary tooth. Dental caries, unspecified

Interventions

Intervention 1: Intervention group: To prepare ice packs for cryotherapy, small silicone ice blocks, sized to the size of the children's oral vestibule, are filled with water and placed in the freezer

Eligibility

Sex/Gender

All

Age

7 Years to 12 Years

Inclusion criteria

Inclusion criteria: Healthy children aged seven to twelve who are in ASA Class I or Class II Have at least two deciduous molars on either side of their lower jaw with a diagnosis of irreversible pulpitis

Exclusion criteria

Exclusion criteria: Necrosis of the tooth in question after access cavity preparation Parent or child withdrawal from continuing the study at any stage of treatment.

Design outcomes

Primary

Measure	Time frame
The outcome variable of anesthesia success on the WB scale is considered a successful treatment with scores of zero and two and a failure with scores of four to ten. Similarly, FBRS grades three and four are considered a successful treatment and grades one and two are considered a failure. Timepoint: In the same treatment session. Method of measurement: To determine the level of pain during pulp treatment, we use two objective and subjective indicators. The Wong-Baker FACES Pain Rating Scale; WBS, which is a set of six facial images, is used to subjectively measure pain. Each child is asked to select a face from the WBS that represents their level of pain.The Face Leg Activity Cry Consolability (FLACC) scale is an objective pain measurement index that includes 5 sections: facial expression, leg position, child activity, crying, and child consolability. Each section is assigned a score between 0 and 2, and the total score is calculated. To measure the level of pain based on the FLACC index, it is performed by another assistant who is independent of the study and its results.	—

Measure

Time frame

The outcome variable of anesthesia success on the WB scale is considered a successful treatment with scores of zero and two and a failure with scores of four to ten. Similarly, FBRS grades three and four are considered a successful treatment and grades one and two are considered a failure. Timepoint: In the same treatment session. Method of measurement: To determine the level of pain during pulp treatment, we use two objective and subjective indicators. The Wong-Baker FACES Pain Rating Scale; WBS, which is a set of six facial images, is used to subjectively measure pain. Each child is asked to select a face from the WBS that represents their level of pain.The Face Leg Activity Cry Consolability (FLACC) scale is an objective pain measurement index that includes 5 sections: facial expression, leg position, child activity, crying, and child consolability. Each section is assigned a score between 0 and 2, and the total score is calculated. To measure the level of pain based on the FLACC index, it is performed by another assistant who is independent of the study and its results.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadfazel Ranjbar

Yazd University of Medical Sciences

mfr.ranjbar@gmail.com+98 35 3822 3075

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026