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SDF Modified Hall Technique Vs. Conventional Pulpotomy for Management of Carious Primary Molars

NCT05240365 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-03-21

No results posted yet for this study

Summary

Dental caries in primary teeth is considered the most common oral disease of childhood and it has been investigated in many places throughout the world. In most developed countries, the prevalence of early childhood caries (ECC) ranges between 1% and 12%. In less developed countries, however, the prevalence is much higher, exceeding 70%.

Pulpotomy is a clinical procedure usually performed in primary molars with extensive caries, which implies removal of the coronal pulp and preservation of the radicular pulp. It is based on the ability of the remaining pulp tissue to heal after the affected or infected coronal pulp has been surgically removed. Pulpotomy is a technique that is highly dependent on a number of factors, including diagnosis accuracy, caries excavation method, pulp dressing material, final restoration quality and operator experience.

Silver diamine fluoride (SDF) has recently become a non-invasive treatment option, it is fluid-form material used in prevention and treatment of teeth cavities (or caries). SDF has been demonstrated to be useful in arresting caries development after a cavity has formed. In hundreds of studies, the only common side effect of SDF has been black staining surrounding the area. SDF has the ability to stain anything it comes into contact with, including clothing and oral tissues.

Hall technique is a method for management primary molar decay that involves the use of preformed metal crowns (PMCs) to seal decay. This technique may be able to stop or at least reduce caries progression in primary teeth. The process of fitting the crown is quick and non-invasive.

Conditions

  • Deep Carious Lesions

Interventions

DEVICE

SDF modified Hall technique

* Preparation for Hall technique and selection of the crown. * Clinical application of SDF. * Cementation of the selected crown.

DEVICE

Conventional pulpotomy and stainless steel crown

* Teeth will be anesthetized . * Rubber dam will be used and high suction in pulpotomy procedure. * Cavity outline will be performed by sterile #330 high speed bur using water spray. * Caries will be removed by large spoon excavator. * pulpal exposure will be occurred then the roof of pulp chamber will be removed by low speed round bur. Hemostasis will be obtained by applying pressure with moist cotton pellet with saline. * Teeth will be treated by using sterile cotton pellet with formcresol for three to five min then, remove it. * Pulp stumps of will be dressed with reinforced zinc oxide eugenol, IRM®\* * Tooth Preparation will be done followed by placement of stainless-steel crown

Sponsors & Collaborators

  • Sondos Naserallah

    lead OTHER

Principal Investigators

  • Gihan M Abuelniel, Professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-07-31
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240365 on ClinicalTrials.gov