Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453005
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-25
Brief Title:
Comparative Evaluation of SMART Hall Technique vs Conventional SS Crown in Primary Molars A Randomized Clinical Trial
Sponsor:
C K S Teja Institute Of Dental Sciences Research
Organization:
C K S Teja Institute Of Dental Sciences Research
Study Overview
Official Title:
Comparative Evaluation of SMART Hall Technique Versus Conventional SS Crown Restoration in Treatment of Carious Primary Molars - A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT
Brief Summary:
Dental caries particularly in primary molars significantly affects childrens 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 345 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 patients 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
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 345 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 patients 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 345 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 345 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 parentguardian to provide informed consent and ensure the childs 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 eg 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
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 345 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 parentguardian to provide informed consent and ensure the childs 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None