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NCT Number: NCT06675058

Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars

The following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists.

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Key information

About this study

A selective case study design will be employed, focusing on primary molars with either occlusal or proximal carious lesions. Children aged between 3 to 7 years meeting the inclusion criteria will be examined clinically and radiographically to assess the extent and location of the carious lesion. Two groups will be involved in the study; primary molars will be submitted to each group based on whether the lesion is proximal or occlusal. Both groups will then receive indirect pulp therapy, and a clinical and radiographic evaluation for one year will be conducted.

The purpose of this study is to examine how the location of caries, whether proximal or occlusal, affects the success rate of IPT in primary molars. Understanding this relationship is essential for developing more tailored clinical approaches in pediatric dentistry to ensure long-term treatment success.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant criteria:
  • Children aged between 3-7 years
  • Children in complete physical and mental health.
  • Children with free medical history.
  • Patient with favorable attitudes, which will be assessed by using Frankl behavior rating.

Teeth criteria:

  • Primary molars with active occlusal or proximal deep caries.
  • Teeth with reversible pulpitis
  • Asymptomatic teeth or teeth with provoked pain of short duration
  • Teeth should be restorable.

Exclusion criteria

  • Clinical signs or symptoms suggesting evidence of pulp degeneration or a non -vital tooth such as:
  • Clinical symptoms or history indicating irreversible pulpitis as (spontaneous pain, throbbing pain).
  • Tenderness to percussion.
  • Soft tissue swelling, abscess, draining fistula or sinus tracts.
  • Pathological Tooth mobility.

Presence of the following Radiographic criteria:

  • Periapical or inter-radicular radiolucency.
  • Internal or external pathological root resorption.
  • Furcation involvement
  • Widening of periodontal space.

Treatment and study plan

Indirect Pulp Treatment

Procedure

Indirect pulp treatment is considered one of the most conservative pulp therapies, which preserves the pulp's vitality in teeth with reversible pulpitis. It has been chosen to be the intervention in both groups as the aim of this study is to assess the impact of caries location (proximal vs. occlusal caries) in influencing the success rate of IPT.

Primary outcomes

  1. Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)

    Time frame: one year follow up

    Clinical success rate will be assess through assessment of the following :

    Post-operative Pain (percentage of absence of pain), Presence or absence of clinical signs (e.g., swelling, abscess, sinus tract), and Pain on Percussion

Secondary outcomes

  1. Radiographic success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT).

    Time frame: one year follow up

    Radiographic Success Rate will be assess every (6, and 12 months) through assessment of the following in the x-ray film :

    No radiographic evidence of periapical or inter-radicular radiolucency, No internal or external root resorption, No furcation involvement, and No widening in the periodontal membrane ligament )

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Adel Abdel Azeem EL-Bardissy, Professor

CONTACT

[email protected]

01271289999

Yomna Hussein Moselhy, Phd Candidate at Cairo Uni

CONTACT

[email protected]

01145566717 ext. 01090058699

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars: A Comparative Clinical Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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