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Clinical Trials/CTRI/2024/07/070692
CTRI/2024/07/070692Not yet recruitingNot Applicable

Assessment of Intraoperative characteristics of dental pulp in carious primary teeth with pulpitis

Dr Komal Yadav1 site in 1 country282 target enrollmentStarted: August 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
282
Locations
1
Primary Endpoint
We will be assessing the colour of pulpal bleed and the duration within which pulpal bleeding stops as the intraoperative characteristics of pulp in the carious teeth affected by pulpitis

Study Overview

Brief Summary

The diagnosis based on history, clinical examination, and radiographic assessment has limitations especially in the pediatric population as it relies on the patient’s response (pain, sensitivity) and radiographs, which offer limited information about the pulp’s health itself. Pain perception is considered subjective and varies between individuals and is less reliable in children. Further, the percussion and sensibility tests depend on the patient’s interpretation, leading to potential inaccuracies. To sum up, there is insufficient evidence to determine whether the presence, nature, and duration of toothache offer accurate information about the extent to which dental pulp is inflamed. Therefore, this cross-sectional study will assess the intraoperative findings of dental pulp in carious primary teeth with pulpitis. These intraoperative findings will further help to serve as a standard to decide regarding the type of treatment that needs to be rendered in carious teeth with pulpitis. Simultaneously, an association can be drawn depending upon study results between the intraoperative dental findings and their preoperative diagnosis.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
4.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • (1) Age group 4 to 9 years.
  • (2) Primary maxillary/mandibular posterior tooth with deep occlusal and/or proximal caries exhibiting the signs of pulpitis i.e. sensitivity and/or pain and/or pulp exposure which is clinically evident [International Caries Detection and Assessment System Score 4, 5, and 6].
  • (3) Children with Frankl’s behavior rating of 3 and 4.

Exclusion Criteria

  • (1) Teeth with gingival abscess and/or extraoral swelling/sinus formation/pathological mobility (2) Patients with systemic disorders and/or a history of long-term medications that can influence the diagnosis.
  • (3) Frankl’s behavior rating of 1 and 2 [uncooperative children].

Outcomes

Primary Outcomes

We will be assessing the colour of pulpal bleed and the duration within which pulpal bleeding stops as the intraoperative characteristics of pulp in the carious teeth affected by pulpitis

Time Frame: At Baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Komal Yadav
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Komal Yadav

All India Institute of Medical Sciences, New Delhi

Study Sites (1)

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