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Outcomes of the Hall Technique and Conventional Pulp Therapy for the Management of Caries in Primary Molars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885271
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hanaa AbdEl Moniem, Cairo University

Brief Summary:
Based on the changing understanding of carious biofilm development and caries progression, Sealing carious dentine beneath a restoration deprives the caries biofilm of nutrients and alters the environment sufficiently to slow or arrest lesion progression. This has the added benefit of avoiding pulp exposure and subsequent treatment .The evidence base supporting the biological approaches which include Hall technique has been steadily increasing in the last few years. This has given rise to a growing trend towards a biological approach by Paediatric dentists and has led to an increasing concern about the merits of conventional approach in treatment of carious primary molars .

Condition or disease Intervention/treatment Phase
Deep Caries Pulpitis - Reversible Other: Hall Technique Other: Formecresol Pulpotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcomes of the Hall Technique and Conventional Pulp Therapy for the Management of Caries in Primary Molars: a Randomized Clinical Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
Experimental: Group A (Experimental group) Hall Technique
Clinical examination to assess the clinical inclusion criteria. Radiographic examination.The child will be positioned upright in the dental chair . The correct size of PMC for the tooth will be selected. The tooth will be rinsed and dried, and the PMC dried. The PMC will be filled with glass ionomer luting cement. The PMC will be placed evenly over the tooth and the child instructed to bite down firmly until the crown was pushed down over the tooth;If the child was unable or unwilling to bite down on the PMC, finger pressure will be used to seat the crown Extruded cement will be removed, and the child will be asked to keep biting on the Hall PMC until the cement sets and once cement sets, excess cement is removed, floss will be used to clear the aproximal contacts, and post-fitting instructions will be given (Innes et al. 2007).
Other: Hall Technique
The Hall technique is a simplified method of utilizing stainless steel crowns in treatment of carious primary molars. The SSC is cemented onto the carious tooth using glass ionomer cement. Since there is no need for carious lesion removal, the use of local anesthesia is not mandate

Active Comparator: Group B (control group) Formecresol Pulpotomy
Clinical examination to assess the clinical inclusion criteria. Radiographic examination. The teeth anesthetized, rubber dam isolation, Complete caries removal achieved with a sterile round steel bur in a slow- speed handpiece. Access to the pulp chamber performed using a sterile slow-speed round steel bur. The pulp amputation with a sterile diamond bur in a high-speed handpiece and pulpal debris removed with a sterile saline solution on a sterile cotton pledget. After pulp amputation haemostasis achieved using a sterile cotton pledget. Formocresol (FC) applied using a sterile cotton pledget for 5 minutes. After removal of the formocresol soaked cotton pledget, the pulp chamber rinsed with water using an air-water syringe. The pulp chamber dried with a sterile cotton pledget, followed by application of Zinc Oxide & Eugenol and zinc phosphate. Tooth preparation done to receive stainless steel crown.
Other: Formecresol Pulpotomy
Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health .This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, Complete caries removal and then access to the pulp chamber using drills




Primary Outcome Measures :
  1. Postoperative pain reported by the patient after pulpotomy and Hall Technique [ Time Frame: 10 days postoperatively ]
    Postoperative pain reported by the patient after pulpotomy and Hall Technique using visual analogue scale .Scale from 0 to 9. (Point 0): No pain ,(Points 1-3): mild pain,(Points 4-6):moderate pain, (7-9): severe pain



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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children:Aged 5 to 7 years, in good general health and medically free.The parents provided a written informed consent.
  • Primary molar with deep dentin caries involving occlusal and or occluso proximal surfaces.
  • Vital pulp with absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
  • Absence of clinical swelling or pus exaudate or fistula of soft or periodontal tissues.
  • Absence of abnormal tooth mobility
  • Absence of pain on percussion

Exclusion Criteria:

  • Patients experience any signs or symptoms of pulpal or periapical pathology.
  • Patients with systemic diseases requiring special dental consideration.
  • Unmotivated uncooperative patients.
  • Patients unable to attend follow up visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885271


Contacts
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Contact: Hanaa A Ibraheem, Ms D 201001081614 ext 201001081614 hanaa.ibraheem@dentistry.cu.edu.eg
Contact: Hanaa A Ibraheem 201001081614 ext 201001081614 hanaa.ibraheem@dentistry.cu.edu.eg

Locations
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Egypt
Hanaa A Ibraheem
Cairo, Egypt, 12566
Contact: Hanaa A Ibraheem    201001081614 ext 201001081614    hanaa.ibraheem@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Hanaa A Ibraheem, MsD Cairo University
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Responsible Party: Hanaa AbdEl Moniem, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03885271    
Other Study ID Numbers: CEBD-CU-2019-03-16
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol, Informed consent form, clinical study report
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 6 months after completion of the study
Access Criteria: ClinicalTrials.gov
URL: http://ClinicalTrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases