A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars.

NCT06350578 | Completed DMC

• 1 other identifier: BUHOOTH-D-23-00073
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries.

Conditions

Approximal Dental Caries (ICDAS 3-5) in Primary Molars of Children

Keywords

Hall Technique; Conventional Restoration; Stainless Steel Crowns; Approximal Caries; Paediatric Dentistry; Non-inferiority Trial; Minimally Invasive Dentistry; Pain Perception; Parental Acceptability; Occlusal Vertical Dimension; Restoration Survival; Tooth Survival; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Restoration survival over 12 months

  Success: * Satisfactory restoration/crown, no intervention required * No clinical or radiographic signs or symptoms of pulp pathology * Tooth exfoliated Minor Failures: * Secondary caries or new lesions detected clinically * Crown presents perforation * Restoration fracture or wear - intervention required * Loss of restoration - tooth that can be re-restored * Crown loss - tooth able to be re-treated * Reversible pulpitis, which could be treated without the need for extraction or pulpotomy Major Failures: * Irreversible pulpitis or dental fistula/abscess requiring pulpotomy or extraction * Loss of restoration/crown - tooth not capable of being re-restored * Periradicular and/or furcation radiolucency

  At 1 month, 6 months, 9 months, and 12 months post-treatment

• Occlusal Vertical Dimension (OVD) resolution

  Will be assessed only in the HT group using a millimetre dental probe.

  Assessments will be conducted at baseline (before treatment), immediately after crown placement, and at follow-up visits at 1, 6, 9, and 12 months post-treatment, with particular emphasis on the 1-month follow-up.

Secondary Outcomes (5)

• Tooth survival over 12 months

  At 1 month, 6 months, 9 months, and 12 months post-treatment

• Procedural Time

  At the time of treatment visit

• Participant's cooperation

  At the time of treatment visit

• Participant's pain perception

  At the time of treatment visit

• Parents' perceptions and opinions regarding treatment

  At the time of treatment visit

Study Arms (2)

Hall Crown Technique

EXPERIMENTAL

HT is a conservative restorative technique used for primary molars with single- or multi-surface carious lesions. This technique involves cementing a SSC directly over the affected primary molar without any caries removal or tooth reduction.

Procedure: Hall Crown Technique

Conventional SSC Technique

ACTIVE COMPARATOR

CT is the traditional restorative technique often used for primary molars with multi-surface carious lesions. This technique involves caries removal and occlusal-proximal tooth surface reduction before crown cementation.

Procedure: Conventional SSC Technique

Interventions

Hall Crown Technique PROCEDURE

The Hall technique (HT) involves cementing Stainless Steel Crowns SSC on carious primary teeth without using rotary instruments nor local anaesthesia, thus eliminating discomfort, and increasing child's behavior.

Hall Crown Technique

Conventional SSC Technique PROCEDURE

The conventional technique involves complete removal of the carious lesion using rotary instruments and local anesthesia, then restoring the tooth with Stainless Steel Crown SSC.

Conventional SSC Technique

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• PHCC paediatric dental patients:
• Whose parents or legal guardians accept and sign the consent form
• Who assent to participation.
• Who aged 3-9 years old.
• Who exhibit generally cooperative behavior.
• Who exhibit good general health conditions.
• Who are presenting at least one occluso-proximal lesion in a primary molar.
• \. From clinical and radiographic examination, caries limited to the occluso-proximal surfaces and extending to enamel or dentine, cavitated or non cavitated.

You may not qualify if:

• Uncooperative children who do not understand the procedure or tolerate biting the crown into its position without local anesthesia.
• Children with special health care needs (SHCN) will be excluded.
• Children with nickel allergies and sensitivity.
• Tooth with signs or symptoms of dental infection or irreversible pulpitis such as:
• A history of spontaneous unprovoked pain, a sinus tract, soft tissue inflammation not resulting from gingivitis or periodontitis, excessive mobility not associated with trauma or exfoliation, furcation/ apical radiolucency, or radiographic evidence of internal/ external resorption (Camp JH 2011).
• Crowns severely destructed with caries, which considered non-restorable (Innes, N.P 2009).
• Teeth with single surface (occlusal) caries.

Sponsors & Collaborators

• Primary Health Care Corporation, Qatar: lead

Study Sites (1)

Primary Healthcare Corporation

Doha, Qatar

Location

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Related Links

• Behavior Guidance for the Pediatric Dental Patient
• Paediatric Restorative Dentistry
• HALL TECHNIQUE VERSUS THE CONVENTIONAL STAINLESS STEEL CROWNS RESTORING CARIOUS PRIMARY MOLAR TEETH: A RANDOMIZED CONTROLLED CLINICAL TRIAL

Study Officials

• Hanan A Mohamed

  Primary Health Care Corporation (PHCC) of Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentistry Specialist

Model Details: A binary outcome non-inferiority randomised trial.

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 5, 2024
• Study Start: December 6, 2023
• Primary Completion: July 27, 2025
• Study Completion: August 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)