Dental Crown Techniques for Tooth Decay

Recruiting in Palo Alto (17 mi)

Overseen by Nathanael O Salako, BDS,MSc

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Medically compromised, Uncooperative behavior, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares different methods to fix cavities in children's baby molars. It looks at how well various techniques work by placing a protective cap over the damaged tooth.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Hall Technique treatment for dental crown techniques in tooth decay?

Research shows that the Hall Technique, which uses stainless steel crowns without drilling or removing decay, is effective for treating decayed primary teeth in children. Studies indicate it has good clinical success and is cost-effective compared to traditional methods. ^{1 2 3 4 5}

Is the Hall Technique for dental crowns safe for humans?

The Hall Technique, which uses stainless steel crowns to treat decayed teeth without drilling or anesthesia, is generally considered safe and has been used successfully in children, although some studies suggest more research is needed to confirm its effectiveness. ^{2 3 6 7 8}

How does the Hall Technique treatment for tooth decay differ from other treatments?

The Hall Technique is unique because it treats decayed primary teeth by sealing them with stainless steel crowns without removing decay, preparing the tooth, or using local anesthesia, making it less invasive compared to traditional methods. ^{1 2 3 5 9}

Research Team

Nathanael O Salako, BDS,MSc

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for medically fit children with cooperative behavior during dental X-rays. It's for those who have primary molars with early-stage tooth decay (D1 lesions) without severe pulp damage or issues at the roots of their teeth as seen on X-rays.

Inclusion Criteria

My child is in good health.

Children who exhibit cooperative behavior at initial bitewing radiograph procedure

My teeth have surface-level cavities.

Exclusion Criteria

My child has a serious health condition.

Children with uncooperative behavior during bitewing radiograph process

I have issues with the roots of my teeth or gum disease around them.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment using Hall Technique, Modified Hall Technique, or Conventional Stainless-Steel Crown restoration for primary molars with proximal caries lesions

1-2 weeks

Follow-up

Participants are monitored for biofilm, gingival health, and occlusal contact post-treatment

12 months

Treatment Details

Interventions

• Conventional Technique (CT) (Procedure)
• Hall Technique (HT) (Procedure)
• Modified Hall Technique (MHT) (Procedure)

Trial Overview The study compares three ways to treat cavities in kids' back teeth: the conventional method using Stainless-Steel Crowns, and two variations called Hall Technique and Modified Hall Technique, which differ in application but aim to be less invasive.

Participant Groups

Group I: Modified Hall Technique (MHT) Experimental Treatment 1 Intervention

Group II: Hall Technique (HT) Experimental Treatment 1 Intervention

Group III: Conventional Technique (CT) Active Control 1 Intervention

Conventional Technique (CT) is already approved in Canada for the following indications:

Approved in Canada as Conventional Stainless-Steel Crown Restoration for:

• Restoration of primary molars with dentinal caries
• Treatment of primary molars with proximal caries lesions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD

Findings from Research

In a study of 65 children, both Conventional and Hall Technique (HT) Preformed Metal Crowns (PMCs) showed high success rates at 24 months, with 97.6% for conventional PMCs and 93.5% for HT PMCs.

While there was no significant difference in success rates at 12 months, the HT PMCs demonstrated a statistically significant higher success rate at 24 months, indicating that HT may offer a slight advantage in long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 24-month retrospective study of preformed metal crowns: the Hall technique versus the conventional preparation method. Binladen, H., Al Halabi, M., Kowash, M., et al.[2022]

In a study of 39 healthy children aged 5-9 years treated with the Hall technique for carious primary teeth, there was no significant increase in temporomandibular dysfunction (TM-D) signs or symptoms over a 12-month follow-up period.

Only a few children exhibited TM-D signs or symptoms, and the overall findings suggest that the Hall technique does not appear to be associated with the development of TM-D in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporomandibular dysfunction assessment in children treated with the Hall Technique: A pilot study. Kaya, MS., Kınay Taran, P., Bakkal, M.[2022]

The Hall Technique (HT) for treating decayed primary teeth using stainless steel crowns showed little to no progression of caries over time, indicating its effectiveness in managing dental decay without traditional preparation methods.

While HT-treated teeth exhibited lower hardness and elastic modulus in carious lesions compared to conventional treatments, they also showed higher calcium and phosphorus levels, suggesting potential remineralization of the retained carious tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrastructure and properties of primary carious molars treated using the Hall Technique. Loch, C., Jansen van Vuuren, L., Duncan, WJ., et al.[2021]

The Hall technique (HT) for restoring primary carious molars was found to be significantly more successful than conventional dental restorations, based on a systematic review of five studies involving 1775 teeth, with 1325 treated using HT.

Meta-analysis results showed a risk ratio of 5.55 favoring HT over traditional methods, indicating a strong preference for HT in achieving successful restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Hall Technique for Primary Carious Molars: A Systematic Review and Meta-analysis. Badar, SB., Tabassum, S., Khan, FR., et al.[2022]

The Hall Technique (HT) is a non-invasive treatment for carious primary molars in children aged 3-7, which involves sealing carious lesions with a stainless steel crown without the need for local anesthesia or removal of carious tissue.

This study aims to evaluate the clinical effectiveness, acceptability, and cost-effectiveness of HT over a 24-month period, with a target sample size of 220 children, to determine its potential for widespread use in managing dental caries in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Hall Technique study: A trial to measure clinical effectiveness and cost-effectiveness of stainless steel crowns for dental caries restoration in primary molars in young children. Tonmukayakul, U., Martin, R., Clark, R., et al.[2019]

The Hall technique for placing stainless steel crowns on primary molars does not require tooth preparation or local anesthesia, making it a less invasive option.

However, a literature review found inconclusive evidence regarding its effectiveness, suggesting that it should not be used in clinical practice at this time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Success of Hall technique crowns questioned. Nainar, SM.[2019]

The Hall technique, which involves sealing decay under preformed metal crowns without removing caries or using anesthesia, was found to be clinically effective in managing carious primary molars in 84 children aged 6-10, with no failures observed within 6 months.

Patient acceptance of the Hall technique was high, as indicated by low discomfort levels reported by children during follow-up assessments, making it a promising alternative for treating dental caries in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Clinical Effectiveness and Patient Acceptance of Hall Technique for Managing Carious Primary Molars: An In Vivo Study. Bhatia, HP., Khari, PM., Sood, S., et al.[2022]

The Hall Technique (HT) is widely recognized among dentists in East China, with 91.4% of surveyed dentists aware of it, but only 40.2% have actually used it, indicating a gap between knowledge and practice.

Concerns about potential complications, such as pulp inflammation or necrosis, are a significant barrier to the adoption of the HT, highlighting the need for more systematic training to increase its utilization in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Hall Technique by dentists in East China: A questionnaire-based cross-sectional survey. Ding, N., Ding, Q., Sheng, K., et al.[2023]

The Hall Technique (HT) for managing carious primary molars showed significantly lower rates of both major and minor failures compared to standard restorations by General Dental Practitioners, with only 3% major failures in HT versus 16.5% in controls after 60 months.

In a study involving 132 children and 264 teeth, HT demonstrated a remarkable advantage in long-term outcomes, with only 5% minor failures compared to 42% in standard restorations, indicating that sealing caries without removal is a highly effective treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sealing caries in primary molars: randomized control trial, 5-year results. Innes, NP., Evans, DJ., Stirrups, DR.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

A 24-month retrospective study of preformed metal crowns: the Hall technique versus the conventional preparation method. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Temporomandibular dysfunction assessment in children treated with the Hall Technique: A pilot study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Ultrastructure and properties of primary carious molars treated using the Hall Technique. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Effectiveness of Hall Technique for Primary Carious Molars: A Systematic Review and Meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Protocol for the Hall Technique study: A trial to measure clinical effectiveness and cost-effectiveness of stainless steel crowns for dental caries restoration in primary molars in young children. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Success of Hall technique crowns questioned. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Evaluation of Clinical Effectiveness and Patient Acceptance of Hall Technique for Managing Carious Primary Molars: An In Vivo Study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Use of the Hall Technique by dentists in East China: A questionnaire-based cross-sectional survey. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Sealing caries in primary molars: randomized control trial, 5-year results. [2012]