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

Dental Caries Clinical Trial

Official title:

Comparative Analysis of Hall Technique and Conventional Method for Stainless Steel Crown Placement in Primary Molars With Approximal Caries: A Randomized Controlled Trial at Primary Healthcare Corporation, Qatar

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350578
• Other study ID #: BUHOOTH-D-23-00073
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Primary Health Care Corporation, Qatar
• Contact: Hanan A Mohamed
• Phone: +97450132314
• Email: hananmohamed[@]phcc.gov.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background: The most common chronic disease in children and adolescents (6-19 years old) is dental caries. The conventional approach of carious lesions treatment involves cavity preparation with rotary instruments, restoration with composite resin, amalgam, or stainless-steel crowns (SSCs). Retrospective studies showed that SSCs have a better success rate compared to amalgam or resin-based restorations when used for multi-surface caries in primary teeth. Hence, the American Academy of Paediatric Dentistry (AAPD) recommended the use of SSCs as the treatment of choice for carious lesions of more than one surface in high-risk children. Recently, the Hall technique (HT) has been used for sealing caries in primary molars. The contemporary technique was first introduced in the literature in 2006 by Dr. Norna Hall while she was working in a high caries-risk area in rural Scotland. The technique has straightforward biological principles, where the most important layer for the caries progression in the biofilm, which is the superficial plaque layer, is left and sealed along with the carious lesion. Consequently, a less cariogenic flora will be composed in the plaque biofilm, thus arresting or slowing down the caries progression in primary teeth. The Hall technique (HT) involves cementing SSC on carious primary teeth without using rotary instruments nor local anaesthesia, thus eliminating discomfort, and increasing child's behaviour. Aim: 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. Methods/Design: The study will compare between the hall technique (HT) and the conventional restoration (CR) using stainless steel crowns (SSCs) in terms of technique acceptability (parents), children's behavior and the perception of pain. Approximal dental caries (ICDAS 3-5) in primary molars of children (3-9 years old) will be managed by two treatment techniques; conventional restorations (CR) using stainless steel crowns (SSCs) and the hall technique (HT). The study will be a binary outcome non-inferiority randomized trial with treatment provided in a primary care dental clinic setting. The study protocol will be written following Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized trials of non-pharmacologic treatment. Participants will be allocated randomly to be treated with SSCs placed with conventional technique CT (control group) or the HT (experimental group) in order to compare different options for arresting occlusal-proximal caries lesions in primary molars. Discussion: The clinical trial seeks to provide evidence on whether Hall technique demonstrate comparable or superior clinical outcomes compared to conventional restorations in terms of children's pain perception and cooperation in dental setting and parents' acceptability as well.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

Inclusion Criteria:

• Participant inclusion criteria:

PHCC paediatric dental patients:

1. Whose parents or legal guardians accept and sign the consent form

2. Who assent to participation.

3. Who aged 3-9 years old.

4. Who exhibit generally cooperative behavior.

5. Who exhibit good general health conditions.

6. Who are presenting at least one occluso-proximal lesion in a primary molar.

Tooth/ carious lesion inclusion criteria:

1. From clinical and radiographic examination, caries limited to the occluso-proximal surfaces and extending to enamel or dentine, cavitated or non cavitated.

Exclusion Criteria:

• 1. Uncooperative children who do not understand the procedure or tolerate biting the crown into its position without local anesthesia.

2. Children with special health care needs (SHCN) will be excluded.

3. Children with nickel allergies and sensitivity.

Tooth/ caries lesion exclusion criteria:

1. 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).

2. Crowns severely destructed with caries, which considered non-restorable (Innes, N.P 2009).

3. Teeth with single surface (occlusal) caries.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Hall Crown Technique
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.
• Conventional SSC Technique
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.

Locations

Country	Name	City	State
Qatar	Primary Healthcare Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Primary Health Care Corporation, Qatar

Country where clinical trial is conducted

Qatar, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration survival at 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 does not capable of being re-restored; Periradicular and/or furcation radiolucency	1-, 6-, 9-, and 12 months
Primary	Occlusal vertical dimension (OVD) resolution	Will be assessed only in the HT group using a millimeter dental probe.	4 weeks post-crown placement.
Primary	Tooth survival	Teeth where treatments are scored as satisfactory or has minor failures, will be scored "successful" while teeth that will present Major Failures will be considered as "failure for tooth." Data related to of the treated tooth will be collected for both groups.	1-, 6-, 9-, and 12 months
Primary	Procedural time	will be recorded in the treatment visit by using a stopwatch for both the Hall technique and the Conventional Technique.	In treatment visit
Secondary	Participant's cooperation	Participant's cooperation will be compared among the two groups of intervention using Child's Behaviour Frankl scale.	In treatment visit
Secondary	Participant's pain perception	Will be compared among the two groups of intervention using the Wong-Baker Faces Pain Scale (WBFPS)	In treatment visit.
Secondary	Treatment perceptions and opinions of the parents	A five-point Likert scales will be used to assess: Child's behaviour, Comfort during treatment, Satisfaction with treatment undertaken, Dentists' ease of treatment provision, The relative time for the procedure, and Would they choose the same treatment option again?	In treatment visit

External Links

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