Skip to content

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05222243
Enrollment
60
Registered
2022-02-03
Start date
2019-01-01
Completion date
2020-12-01
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Direct Pulp Capping in Primary Teeth

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.

Interventions

DRUGDirect pulp capping with calcium hydroxide

Capping exposed dental pulps during cavity preparation in primary teeth with calcium hydroxide

Capping exposed dental pulps during cavity preparation in primary teeth with MTA

DRUGDirect pulp capping with Formocresol

Capping exposed dental pulps during cavity preparation in primary teeth with zinc oxide eugenol after medication with formocresol

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Radiolucency of the periapical or furcation area12 monthsmeasuring tool is x-ray

Secondary

MeasureTime frameDescription
Widening of the periodontal space12 monthsmeasuring tool is x-ray
Calcification of the pulp canal12 monthsmeasuring tool is x-ray
Spontaneous pain12 monthsnumeric rating scale (presence or abscence of pain) 0 is best result 10 is the worst
Pathological internal or external root resorption12 monthsmeasuring tool is x-ray
Presence or absence of fistula12 monthsvisual inspection
Pathological mobility12 monthsmobility is graded clinically by applying pressure with ends of two metal instruments
Sensitivity on percussion and palpation12 monthsmethods of tapping on surface in clinical examination

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026