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

Not Applicable

Not yet recruiting

• Conditions: Deep Caries Lesion of Primary Teeth; Dental Pulp Diseases; Deep Proximal Caries; Deep Occlusal Caries; Reversible Pulpitis; Pulpitis; Decayed Teeth

• Registration Number: NCT06675058
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Study Start: 2024-12-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Participant criteria:

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

Teeth criteria:

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)	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 Outcome Measures

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