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

NCT05240365 | Unknown

• 1 other identifier: SDF Modified Hall
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Any pain and discomfort experienced by the child were recorded using the Faces Pain Scale-Revised (FPS-R).The endpoints were labeled 'no pain' and 'very much pain'. The FPS-R faces were scored as 0-2-4-6-8-10.

  24 hours postoperatively

Secondary Outcomes (3)

• Radiographic success

  one year

• Chair side time

  immediately after the procedure

• Child cooperation

  immediately after the procedure

Study Arms (2)

SDF modified Hall technique

EXPERIMENTAL

When Hall technique is used an accurate size of PMC is placed without local anesthesia, caries removal, or tooth preparation. SDF is applied directly to carious lesions to arrest caries, the technique is noninvasive and relatively painless that could be a good option for treating dental caries in children

Device: SDF modified Hall technique

Conventional pulpotomy and stainless steel crown

ACTIVE COMPARATOR

Amputation of the coronal pulp and treatment of the remaining vital radicular portion with a long term clinically successful medicament. Then using an accurate size of stainless steel crown.

Device: Conventional pulpotomy and stainless steel crown

Interventions

SDF modified Hall technique DEVICE

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

SDF modified Hall technique

Conventional pulpotomy and stainless steel crown DEVICE

* 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

Conventional pulpotomy and stainless steel crown

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children: Age 4 to 7 years medically free.
• Primary molars with deep caries.
• Vital pulp with no clinical signs and symptoms of irreversible pulpitis such as spontaneous pain.
• Absence of swelling or pus exudate or fistula.
• Absence of abnormal teeth mobility
• Absence of pain on percussion

You may not qualify if:

• Patients experience signs or symptoms of pulpal or periapical pathology.
• Patients requiring special dental consideration.
• Unmotivated uncooperative patients.
• Patients can't attend follow up visits.

Sponsors & Collaborators

• Sondos Naserallah: lead

Study Officials

• Gihan M Abuelniel, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Sondos A Naserallah, B.D.S

CONTACT

01141004620; sondos.ahmed@dentistry.cu.edu.eg

Passant Nagi, PhD

CONTACT

01280557107; passant.nagi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 15, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share