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

NCT06675058 | Not Yet Recruiting

• 1 other identifier: 14422023530604
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

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

  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

  one year follow up

Secondary Outcomes (1)

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

  one year follow up

Study Arms (2)

Primary teeth with deep proximal caries

EXPERIMENTAL

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.

Procedure: Indirect Pulp Treatment

Primary teeth with deep occlusal caries

ACTIVE COMPARATOR

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

Procedure: Indirect Pulp Treatment

Interventions

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 teeth with deep occlusal caries; Primary teeth with deep proximal caries

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Diseases; Pulpitis; Dental Caries

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Central Study Contacts

Yomna Hussein Moselhy, Phd Candidate at Cairo Uni

CONTACT

01145566717; dr.yomnahussein.edu@gmail.com

Dr. Adel Abdel Azeem EL-Bardissy, Professor

CONTACT

01271289999; adelbardissy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Yomna Hussein Moselhy

Model Details: a Selective Case Study ( Prospective Clinical Trial)

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 18, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11