Clinical trial NCT06453005: Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial
Official title: Comparative Evaluation of SMART Hall Technique Versus Conventional SS Crown Restoration in Treatment of Carious Primary Molars - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Pain
Plaque, Dental
Gingival Bleeding
Keywords: Randomized Clinical Trial
Dental caries
Primary molars
Stainless Steel Crowns
SMART Hall Technique
Conventional Technique
Silver Diamine Fluoride
Split Mouth Study
Lead sponsor: C K S Teja Institute Of Dental Sciences & Research
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Our study involves comparing two different dental treatment modalities (SMART Hall technique and standard SSC restoration) in a split-mouth design, where each participant serves as their control, the Single group model aligns with the structure of your study. This model indicates that all participants receive the intervention(s) being studied, which is consistent with our split-mouth study design.
Primary purpose: TREATMENT

Brief summary: Dental caries, particularly in primary molars, significantly affects children's oral health and overall well-being. Traditional management with stainless steel crowns (SSCs) involves significant tooth reduction and advanced dental skills. Introduced in the 1970s, the Hall technique offers a less invasive alternative, minimizing tooth reduction compared to SSCs.

The SMART Hall technique represents a further evolution, emphasizing atraumatic cavity preparation using hand instruments. It offers advantages like minimal or no tooth reduction, minimized discomfort, improved patient cooperation, shorter treatment times, and cost-effectiveness.

Silver Diamine Fluoride (SDF) emerges as a promising non-invasive approach for managing dental caries in primary teeth, though it may cause temporary tooth discoloration. However, comparative evaluation with traditional SSC restorations remains limited.

To address this gap, a randomized clinical trial will evaluate the treatment outcomes of the SMART Hall technique versus conventional SSC restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of young patients. Children aged 3 to 9 years requiring restorations will be included, assessing clinical outcomes, treatment time duration, and radiographical outcomes of both techniques at specific follow-up intervals of 3 months \& 6 months.

This split mouth study will explore Clinical outcomes, radiographical outcomes, treatment time duration, and patient's pain perception with the chosen treatment modality. The findings will provide insights into the effectiveness and feasibility of the SMART Hall technique compared to the traditional SSC approach, informing evidence-based decision-making in pediatric dentistry and influencing treatment recommendations for preserving the health and function of primary molars in young children.

Detailed description: AIM OF THE STUDY The aim of this research study is to compare the treatment outcomes of the SMART Hall technique with conventional stainless steel crown (SSC) restoration for managing occluso-proximal carious lesions (ICDAS CODE 3/4/5) in primary molars of 3- to 9-year-old children.

OBJECTIVES OF THE STUDY

1. To evaluate and compare the clinical success rates of the SMART Hall technique and conventional SSC restoration in managing occluso-proximal carious lesions in primary molars over a follow-up period of 3 \& 6 months.
2. To evaluate and compare the treatment time duration of the SMART Hall technique and conventional SSC restoration in managing occluso-proximal carious lesions in primary molars.
3. To assess and compare the survival rates of teeth restored using the SMART Hall technique and conventional SSC restoration over a follow-up period of 3 \& 6 months.
4. To assess and compare the radiographical outcomes of teeth restored using the SMART Hall technique and conventional SSC restoration over a follow-up period of 3 \& 6 months.
5. To analyze and compare patient-reported perceptions of treatment using a Visual Analogue Scale between the two treatment modalities.

INCLUSION CRITERIA

1. Children aged 3 to 9 years old.
2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
3. Requirement for restorative treatment in the form of either the SMART Hall technique or conventional stainless steel crown (SSC) restoration, as determined by clinical assessment.
4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.

EXCLUSION CRITERIA

1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.
2. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants, unless medically managed and deemed safe by the treating healthcare provider.
3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.
4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.
5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.

METHODOLOGY Patients attending the Department Pedodontics \& Preventive Dentistry department will be screened for identifying patients who fit into the inclusion \& exclusion criteria. A total of 50 patients will be listed accordingly. Patients' parents / Guardian will be explained about the research study and treatments involved. Further, 25 patients will be randomly selected according to the determined sample size. Additional 5 patients will be recruited keeping in my the possibility of case attrition. A simple random selection method will be employed using Microsoft Excel program to generate patient pool to participate in this split mouth study.

Sampling method:

Probability sampling method, Simple Random sampling method using random number generators (RNGs)

Blinding:

Patients, Biostatistician and trained clinicians involved in evaluating clinical and radiographical outcomes will be kept blind about the type of treatment done in which primary tooth.

Training of examining clinicians:

To standardize the methods for training examiners in assessing clinical and radiographical outcomes, following steps will be followed:

1. Standardized protocol: These will outline the criteria and methods for assessing clinical and radiographical outcomes.
2. Training sessions: Conducting training sessions for the examiners to familiarize them with the standardized protocols.
3. Practice cases: Providing examiners with practice cases to assess using the standardized protocol.
4. Calibration exercises: Conducting calibration exercises to assess inter-examiner and intra-examiner variability. In these exercises, multiple examiners independently assess the same set of cases using the standardized protocol.

Assessing inter-examiner and intra-examiner variability: Intraclass Correlation Coefficient (ICC) statistical test will be employed to check for both inter-examiner and intra-examiner variability.

Blinding of biostatistician: Blinding the biostatistician to the type of treatment modality to minimize potential bias in data analysis. Providing data labeled as "treatment modality 1" and "treatment modality 2" in the Excel sheet effectively conceals the treatment assignment from the biostatistician.

Criteria for Clinical Assessment are as follows:

Successful

* Restoration appears satisfactory. No intervention required.
* No clinical sign or symptom of pulpal pathology
* No pulpal pathology visible on X-Ray.
* Tooth exfoliated

Minor failure

* Crown loss and tooth restorable
* Crown perforation
* Marginal caries
* Reversible pulpitis.

Major failure

* Irreversible pulpitis
* Dental abscess
* Crown loss and tooth is unrestorable
* Periradicular radiolucency

Clinical Parameters used in assessment are as follows:

* Pain - Present / Absent
* Mobility - Present / Absent
* Tender on percussion - Present / Absent
* Abscess or Sinus - Present / Absent

Radiographical Parameters used in assessment are as follows:

* No abnormal findings - Present / Absent
* Root resorption - Present / Absent
* Periapical pathology - Present / Absent
* Internal resorption - Present / Absent
* Furcation involvement - Present / Absent

The Visual Analogue Scale (VAS) will be utilized to evaluate patients' treatment experience.

Eligibility criteria: Inclusion Criteria:

1. Children aged 3 to 9 years old.
2. Presence of occluso-proximal carious lesions (ICDAS CODE 3/4/5) in one or more primary molars, confirmed through clinical examination and radiographic assessment.
3. Requirement for restorative treatment in the form of either the SMART Hall technique or standard stainless steel crown (SSC) restoration, as determined by clinical assessment.
4. Willingness and ability of the parent/guardian to provide informed consent and ensure the child's attendance at follow-up appointments.
5. Adequate cooperation of the child during dental treatment and evaluation procedures, as determined by the clinician.

Exclusion Criteria:

1. Presence of severe systemic medical conditions (e.g., uncontrolled diabetes, immunodeficiency disorders) that may compromise treatment outcomes or pose risks during dental procedures.
2. Use of medications known to interfere with dental treatment or healing, such as anticoagulants or immunosuppressants, unless medically managed and deemed safe by the treating healthcare provider.
3. History of adverse reactions to dental materials or procedures that may contraindicate participation in the study.
4. Inability of the child to tolerate local anesthesia or undergo dental treatment due to psychological, behavioral, or developmental factors.
5. Presence of extensive dental caries or additional oral pathologies requiring urgent or specialized dental care beyond the scope of the study.

Primary outcomes:
measure: Successful
timeFrame: Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.
Secondary outcomes:
measure: Minor failure
timeFrame: Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.
measure: Major failure
timeFrame: Clinical success and survival rates of the procedure will be assessed at specific follow-up intervals of 3 months & 6 months.
Other outcomes:
Locations:
city: Tirupati
country: India
facility: Dr Pakkirawadi Katika Saraswathi Bai
state: Andhrapradesh
Study officials:
affiliation: Post Graduate Student in Department of Pediatric Dentistry & Preventive Dentistry
name: Saraswathi Bai Pakkirawadi Katika, M.D.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayedun OS, Oredugba FA, Sote EO. Comparison of the Treatment Assessments of the Conventional Stainless-Steel Crown Restorations and the Hall Technique. West Afr J Med. 2020 Jul-Aug;37(3):253-259.
citation: Ayedun OS, Oredugba FA, Sote EO. Comparison of the treatment outcomes of the conventional stainless steel crown restorations and the hall technique in the treatment of carious primary molars. Niger J Clin Pract. 2021 Apr;24(4):584-594. doi: 10.4103/njcp.njcp_460_20.
citation: Ludwig KH, Fontana M, Vinson LA, Platt JA, Dean JA. The success of stainless steel crowns placed with the Hall technique: a retrospective study. J Am Dent Assoc. 2014 Dec;145(12):1248-53. doi: 10.14219/jada.2014.89.