DPC in Primary Molars.

NCT05222243 | Completed Phase 4

• 1 other identifier: 05030718
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Direct Pulp Capping in Primary Teeth

Outcome Measures

Primary Outcomes (1)

• Radiolucency of the periapical or furcation area

  measuring tool is x-ray

  12 months

Secondary Outcomes (7)

• Pathological internal or external root resorption

  12 months

• Widening of the periodontal space

  12 months

• Calcification of the pulp canal

  12 months

• Spontaneous pain

  12 months

• Sensitivity on percussion and palpation

  12 months

Study Arms (3)

Calcium Hydroxide (CH)

ACTIVE COMPARATOR

Calcium Hydroxide is the gold standard for direct pulp capping depends on regeneration

Drug: Direct pulp capping with calcium hydroxide

MTA

EXPERIMENTAL

Mineral trioxide aggregate used for pulp regeneration

Drug: Direct pulp capping with MTA

Formocresol (FC)

EXPERIMENTAL

composed of formaldehyde, cresol, glycerin and water used for fixation of pulp tissue

Drug: Direct pulp capping with Formocresol

Interventions

Direct pulp capping with calcium hydroxide DRUG

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

Calcium Hydroxide (CH)

Direct pulp capping with MTA DRUG

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

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

Formocresol (FC)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• otherwise

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Calcium Hydroxide; Pemetrexed; formocresol

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: February 3, 2022
• Study Start: January 1, 2019
• Primary Completion: August 3, 2020
• Study Completion: December 1, 2020
• Last Updated: February 3, 2022

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)