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Completed

NCT Number: NCT05222243

DPC in Primary Molars.

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • otherwise

Treatment and study plan

Direct pulp capping with calcium hydroxide

Drug

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

Direct pulp capping with MTA

Drug

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

Direct pulp capping with Formocresol

Drug

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

Primary outcomes

  1. Radiolucency of the periapical or furcation area

    Time frame: 12 months

    measuring tool is x-ray

Secondary outcomes

  1. Pathological internal or external root resorption

    Time frame: 12 months

    measuring tool is x-ray

  2. Widening of the periodontal space

    Time frame: 12 months

    measuring tool is x-ray

  3. Calcification of the pulp canal

    Time frame: 12 months

    measuring tool is x-ray

  4. Spontaneous pain

    Time frame: 12 months

    numeric rating scale (presence or abscence of pain) 0 is best result 10 is the worst

  5. Sensitivity on percussion and palpation

    Time frame: 12 months

    methods of tapping on surface in clinical examination

  6. Presence or absence of fistula

    Time frame: 12 months

    visual inspection

  7. Pathological mobility

    Time frame: 12 months

    mobility is graded clinically by applying pressure with ends of two metal instruments

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.