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

NCT03885271 | Completed

• 1 other identifier: CEBD-CU-2019-03-16
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 .

Conditions

Deep Caries; Pulpitis - Reversible

Outcome Measures

Primary Outcomes (1)

• Postoperative pain reported by the patient after pulpotomy and Hall Technique

  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

  10 days postoperatively

Study Arms (2)

Group A (Experimental group) Hall Technique

EXPERIMENTAL

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

Group B (control group) Formecresol Pulpotomy

ACTIVE COMPARATOR

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

Interventions

Hall Technique OTHER

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

Group A (Experimental group) Hall Technique

Formecresol Pulpotomy OTHER

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

Group B (control group) Formecresol Pulpotomy

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hanaa A Ibraheem

Cairo, 12566, Egypt

Location

Study Officials

• Hanaa A Ibraheem, MsD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 21, 2019
• Study Start: May 1, 2020
• Primary Completion: July 15, 2021
• Study Completion: August 1, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after completion of the study
• Access Criteria: ClinicalTrials.gov

Locations

EG (1)