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

NCT ID: NCT06675058

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-08-18

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Primary teeth with deep proximal caries

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.

Group Type: EXPERIMENTAL

Indirect Pulp Treatment

Intervention Type: 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 teeth with deep occlusal caries

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

Group Type: ACTIVE_COMPARATOR

Indirect Pulp Treatment

Intervention Type: 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.

Interventions

Indirect Pulp Treatment

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yomna Hussein Moselhy Sayed Ahmed

Dr. Yomna Hussein Moselhy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yomna Hussein Moselhy, Phd Candidate at Cairo Uni

Role: CONTACT

dr.yomnahussein.edu@gmail.com

01145566717 ext. 01090058699

Dr. Adel Abdel Azeem EL-Bardissy, Professor

Role: CONTACT

adelbardissy@dentistry.cu.edu.eg

01271289999

Other Identifiers

14422023530604

Identifier Type: -

Identifier Source: org_study_id