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

November 4, 2024 updated by: Yomna Hussein Moselhy Sayed Ahmed, Cairo University

Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars: A Comparative Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Active Comparator: 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
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)
Time Frame: 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
one year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT).
Time Frame: 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 )
one year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 18, 2026

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14422023530604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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