Clinical trial NCT06675058: Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars
Official title: Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Deep Caries Lesion of Primary Teeth
Dental Pulp Diseases
Deep Proximal Caries
Deep Occlusal Caries
Reversible Pulpitis
Pulpitis
Decayed Teeth
Keywords: Indirect Pulp Treatment
IPT
Caries location
Caries Site
Proximal and occlusal Caries
Proximal Caries
Occlusal Caries
Pulp Therapy
Reversible Pulpitis
Pulpitis
deciduous teeth
Caries in milk teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a Selective Case Study ( Prospective Clinical Trial)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)
timeFrame: one year follow up
Secondary outcomes:
measure: Radiographic success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT).
timeFrame: one year follow up
Other outcomes:
Locations:
Study officials:
References: