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

Cairo University (CU)

Status: Not yet enrolling

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

Treatments: Procedure: Indirect Pulp Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06675058

14422023530604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Primary teeth with deep proximal caries

Experimental group

Description:

In primary molars with deep proximal caries indirect pulp treatment will be performed by removing infected dentin while affected dentin in pulpal floor will be left in place. Teeth will be capped by a dressing material.

Treatment:

Procedure: Indirect Pulp Treatment

Primary teeth with deep occlusal caries

Active Comparator group

Description:

In primary molars with deep occlusal caries also IPT will be performed. Soft infected dentin will be carefully removed until the dried, hardened affected dentin with a leathery consistency reached then teeth will be capped by a dressing material

Treatment:

Procedure: Indirect Pulp Treatment