DPC in Primary Molars.

Evaluation of Calcium Hydroxide Paste, Mineral Trioxide Aggregate and Formocresol as A Direct Pulp Capping in Primary Molars. Randomized Controlled Clinical Trial

To evaluate clinical and radiographical outcomes of direct pulp capping using calcium hydroxide (CH), mineral trioxide aggregate (MTA), and premedicated direct pulp capping (PDPC) with formocresol (FC) in primary teeth.

Study Overview

• Status: Completed
• Conditions: Direct Pulp Capping in Primary Teeth
• Intervention / Treatment: Drug: Direct pulp capping with calcium hydroxide; Drug: Direct pulp capping with MTA; Drug: Direct pulp capping with Formocresol

Detailed Description

The pulp is imperiled by many environmental impacts. Caries, trauma, restorations, and mechanical injury during cleaning, all are possible aggressions that may injury the pulp tissue. When lesion disrupt enamel barrier, dentin can be degraded by Gram-positive bacteria, such as actinomyces, lactobacilli, and streptococci, that largely dominate the microflora of carious lesion. Pulp response differs according to the degree of the insult. The inflammatory reaction can cause permanent damage or be followed by repair, as the pulp cells have the ability to differentiate into odontoblasts forming dentin matrix facilitating wound healing.

Calcium hydroxide was introduced to the dental practice in the 1920s, and early clinical studies using it in direct pulp capping showed an 80-90 percent success rate.Recent studies with longer follow-up periods suggest lower success rates for it.Calcium hydroxide was used in many forms alone and mixed with other materials for many applications in the dental profession. For direct pulp capping calcium hydroxide powder and aqueous paste were used at first then premixed and cement-based types were developed.

Mineral trioxide aggregate (MTA) was introduced to the dental practice in the 1990s as a root-end filling material. MTA is used as a gold standard in endodontics and has a variety of applications such as root-end filling, apexification, root and truck perforations, apexogenesis, pulp capping in permanent and primary teeth, and dressing for pulpotomy in primary teeth. It is mainly composed of tricalcium silicate, tricalcium aluminate, dicalcium silicate, bismuth oxide, and calcium sulfate dehydrate.

Several studies have shown the efficacy of direct pulp capping using calcium hydroxide and MTA in permanent teeth. However, its use in primary teeth is controversial and few studies are available regarding that subject. Formocresol is not known to be used in direct pulp capping techniques, however, its high clinical success in pulpotomy techniques for primary teeth promoted the investigation of its possible use as direct capping medicament. In addition, there are not enough collected clinical and histological data about direct capping in primary teeth to assess the true success of treatment. Accordingly, the study was directed to evaluate the histological and clinical success of different materials in direct pulp capping for primary teeth.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Absence of chronic systemic disease and any type of medical treatment or continues use of any medication.
2. Absence of drug allergies, anesthetics, and environmental allergies.
3. Cooperative patients.
4. Restorable teeth with deep decay lesions.
5. Teeth with signs of reversible pulpitis; no spontaneous pain; and absence of edema, pain, fistula, pathological mobility, and sensitivity to percussion.
6. True pinpoint exposure (small exposure surrounded by sound dentin with normal bleeding easily controlled)
7. Teeth with no pathological root resorption, periradicular or furcal radiolucency.
8. Teeth with less than one-third physiological root resorption (no resorption or one-fourth resorption of the root).

Exclusion Criteria:

• otherwise

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Calcium Hydroxide (CH); Calcium Hydroxide is the gold standard for direct pulp capping depends on regeneration	Drug: Direct pulp capping with calcium hydroxide; Capping exposed dental pulps during cavity preparation in primary teeth with calcium hydroxide
Experimental: MTA; Mineral trioxide aggregate used for pulp regeneration	Drug: Direct pulp capping with MTA; Capping exposed dental pulps during cavity preparation in primary teeth with MTA
Experimental: Formocresol (FC); composed of formaldehyde, cresol, glycerin and water used for fixation of pulp tissue	Drug: Direct pulp capping with Formocresol; Capping exposed dental pulps during cavity preparation in primary teeth with zinc oxide eugenol after medication with formocresol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiolucency of the periapical or furcation area	measuring tool is x-ray	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological internal or external root resorption	measuring tool is x-ray	12 months
Widening of the periodontal space	measuring tool is x-ray	12 months
Calcification of the pulp canal	measuring tool is x-ray	12 months
Spontaneous pain	numeric rating scale (presence or abscence of pain) 0 is best result 10 is the worst	12 months
Sensitivity on percussion and palpation	methods of tapping on surface in clinical examination	12 months
Presence or absence of fistula	visual inspection	12 months
Pathological mobility	mobility is graded clinically by applying pressure with ends of two metal instruments	12 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 05030718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No