Actively Recruiting

Phase Not Applicable
Age: 3Years - 9Years
All Genders
Healthy Volunteers
ID06453005

Comparative Evaluation of SMART Hall Technique Versus Conventional Stainless Steel Crown Restoration in Treatment of Carious Primary Molars

Led by C K S Teja Institute Of Dental Sciences & Research · Updated on 2025-03-03

30

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Dental caries in primary molars is a common issue affecting children's oral health and well-being. Researchers are comparing the SMART Hall technique, a newer, less invasive method using gentle cavity preparation, with the traditional stainless steel crown (SSC) restoration. This randomized clinical trial aims to evaluate outcomes like clinical success, treatment time, radiographic results, and patient pain perception in children aged 3 to 9 years with specific types of carious lesions. The study uses a split-mouth design where each child receives both treatments, allowing direct comparison. The SMART Hall technique involves minimal or no tooth removal and uses glass ionomer cement, while the SSC method includes more extensive tooth preparation. Both treatments include follow-up assessments at 3 and 6 months to monitor outcomes. Participants will be assessed through clinical exams, radiographs, and pain scales. Researchers will track treatment success, failures, and patient comfort. The trial includes careful monitoring of clinical signs like pain and abscesses, as well as radiographic changes. The total participation involves treatment visits and follow-ups over six months to gather comprehensive data on both techniques.

CONDITIONS

Brief Title

Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial

Who Can Participate

Age: 3Years - 9Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 9 years old
  • Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars confirmed by clinical and radiographic exam
  • Need for restorative treatment by SMART Hall technique or conventional stainless steel crown restoration
  • Parent or guardian willing to provide consent and ensure follow-up attendance
  • Child able to cooperate during dental treatment and evaluation
Not Eligible

You will not qualify if you...

  • Severe systemic medical conditions such as uncontrolled diabetes or immune disorders
  • Use of medications interfering with dental treatment or healing unless medically managed
  • History of adverse reactions to dental materials or procedures
  • Child unable to tolerate local anesthesia or dental treatment due to psychological, behavioral, or developmental issues
  • Extensive dental caries or other oral problems requiring urgent or specialized care beyond the study scope

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session per technique

Participants receive two dental treatments in a split-mouth design: the SMART Hall technique and conventional stainless steel crown restoration for carious primary molars.

1 to 2 treatment visits depending on the dental procedure

Follow-up

Duration - 6 months

Participants attend follow-up visits to assess clinical and radiographical outcomes of both dental treatments.

2 visits at 3 months and 6 months post-treatment

Trial Site Locations

Total: 1 location

1

Dr Pakkirawadi Katika Saraswathi Bai

Tirupati, Andhrapradesh, India, 517501

Actively Recruiting

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Research Team

S

Saraswathi Bai Pakkirawadi Katika, M.D.S

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars.

O S Ayedun, F A Oredugba, E O Sote

https://pubmed.ncbi.nlm.nih.gov/33851682