DPC in Primary Molars.

Phase 4

Completed

• Conditions: Direct Pulp Capping in Primary Teeth
• Interventions: Drug: Direct pulp capping with calcium hydroxide; Drug: Direct pulp capping with Formocresol; Drug: Direct pulp capping with MTA

• Registration Number: NCT05222243
• Lead Sponsor: Mansoura University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-07
• Study Start: 2019-01-01
• Primary Completion: 2020-08-03
• Study Completion: 2020-12-01
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

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Exclusion Criteria

• otherwise

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium Hydroxide (CH)	Direct pulp capping with calcium hydroxide	Calcium Hydroxide is the gold standard for direct pulp capping depends on regeneration
Formocresol (FC)	Direct pulp capping with Formocresol	composed of formaldehyde, cresol, glycerin and water used for fixation of pulp tissue
MTA	Direct pulp capping with MTA	Mineral trioxide aggregate used for pulp regeneration

Primary Outcome Measures

Name	Time	Method
Radiolucency of the periapical or furcation area	12 months	measuring tool is x-ray

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt