Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378814
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-03-12
Brief Title:
Outcome of Selective Nonselective Caries Removal in Permanent Teeth
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Randomized Clinical Trial of Treatment Outcomes of Selective Versus Nonselective Caries Removal in Deep Carious Lesions in Permanent Teeth
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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-SNCR
Brief Summary:
Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists The aim of this trial is to compare the success rate of the non-selective caries removal NSCR and selective caries removal SCR in managing deep caries as both methods are commonly used in clinical practice
This study will be a randomized controlled trial with participants divided into two groups NSCR group and SCR group Participants of deep caries lesions reaching more than two-thirds of dentin on periapical radiographs Both groups will undergo either NSCR or SCR followed by Partial Pulpotomy PP in cases with pulp exposure Success rates will be assessed at follow-up visits scheduled 1 3 and 5 years radiographs will be used to assess for pulp healthvitality
The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality caries recurrence and clinical signs of pulpitis The scale will be applied at follow-up visits The trial will be conducted in post-graduate dental clinics at Guys hospital
Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions as both NSCR and SCR are commonly used in clinical practice The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients
In conclusion this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth as both methods are commonly used in clinical practice The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches
This study will be a randomized controlled trial with participants divided into two groups NSCR group and SCR group Participants of deep caries lesions reaching more than two-thirds of dentin on periapical radiographs Both groups will undergo either NSCR or SCR followed by Partial Pulpotomy PP in cases with pulp exposure Success rates will be assessed at follow-up visits scheduled 1 3 and 5 years radiographs will be used to assess for pulp healthvitality
The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality caries recurrence and clinical signs of pulpitis The scale will be applied at follow-up visits The trial will be conducted in post-graduate dental clinics at Guys hospital
Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions as both NSCR and SCR are commonly used in clinical practice The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients
In conclusion this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth as both methods are commonly used in clinical practice The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches
Detailed Description:
The clinical trial aims to compare the outcomes of non-selective versus selective caries removal
1 Recruiting patients This will involve symptomatic patients attending Guys and St Thomass NHS Foundation Trust GSTT dental clinics To ensure voluntary participation potential volunteers will be informed that they are free to decline without providing a reason with written informed consent gained The study will assess the success and survival rates of different caries excavation techniques in common clinical use currently
Both techniques are used routinely as a standard of care at GSTT Patients will receive the same treatment as caries removal but the difference will be in the technique that will be used and the decision of which will be used will be by the randomization Patients will be randomized on the base of the tooth to one of the two caries removal techniques
Competent adult patients meeting inclusion criteria will receive appropriate dental care as part of their routine clinical management and any abnormal findings will be communicated to them Participants will be informed about the exposure to radiation involved in the study protocol and will receive periapical and bitewing radiograph Periapical and bitewing radiographs are x rays those used routinely at GSTT Also they will be informed that In the unlikely event of treatment failure patients will be offered root canal treatment to provide definite care Patients will be randomized through an audited clinical trials tool
2 Clinical examination and treatment Any abnormal clinical findings identified as a result of participation in this study will be communicated to the participants and they will receive appropriate dental care as part of their routine clinical management If required patients may be referred to the appropriate clinical team or clinician for treatment as appropriate This includes clinicians in the dental hospital andor medical practitioners Participants will be informed of this in the patient information sheet and provide their consent In the unlikely event of treatment failure patients will be offered root canal treatment to provide definite care
3 Biological samples including dentin saliva oral swabs and blood will be acquired during restorative procedures and stored at -80C for optimal preservation Proteomic analysis will be performed using high-resolution liquid chromatography-tandem mass spectrometry LC-MSMS on dentin and saliva samples while enzyme assays will quantify protease activities particularly focusing on matrix metalloproteinases MMPs Bacterial enumeration will be conducted using qPCR Quantitative Polymerase Chain Reaction techniques offering both specificity and sensitivity in microbial identification correlated with the microbial community composition as determined by sequencing approaches Biological specimen will be obtained by trained competent dentally-trained operators trained post-graduate students who are treating patients routinely at Guys clinics as they are part of dental team Biological specimen will be stored and managed within HTA Human Tissue Authorization-approved freezers on site
PhDDoctor of Philosophy student is the involved with the samples transfer and analysis where she is going to take training and certificates needed including HTA certificate
4 Radiation exposure will be limited to radiographs necessary in routine care No extra radiation will be given to patients as they are all routine of care radiographs at GSTT
5 Confidentiality will be ensured by Pseudo-anonymization which will be performed by assigning a code to the patients ID Identification number All data and decoding will be kept separately on two different password-protected computers at each site Access to the decoded data will be restricted to the chief investigator and academic supervisors until interim or final statistical analysis All patients will be assured confidentiality and no data submitted to statistical analysis will be traceable back to an individual patient
The clinical trial will adhere to the principles of the Declaration of Helsinki Patients may withdraw from the study at any time and their clinical care will be unaffected
1 Recruiting patients This will involve symptomatic patients attending Guys and St Thomass NHS Foundation Trust GSTT dental clinics To ensure voluntary participation potential volunteers will be informed that they are free to decline without providing a reason with written informed consent gained The study will assess the success and survival rates of different caries excavation techniques in common clinical use currently
Both techniques are used routinely as a standard of care at GSTT Patients will receive the same treatment as caries removal but the difference will be in the technique that will be used and the decision of which will be used will be by the randomization Patients will be randomized on the base of the tooth to one of the two caries removal techniques
Competent adult patients meeting inclusion criteria will receive appropriate dental care as part of their routine clinical management and any abnormal findings will be communicated to them Participants will be informed about the exposure to radiation involved in the study protocol and will receive periapical and bitewing radiograph Periapical and bitewing radiographs are x rays those used routinely at GSTT Also they will be informed that In the unlikely event of treatment failure patients will be offered root canal treatment to provide definite care Patients will be randomized through an audited clinical trials tool
2 Clinical examination and treatment Any abnormal clinical findings identified as a result of participation in this study will be communicated to the participants and they will receive appropriate dental care as part of their routine clinical management If required patients may be referred to the appropriate clinical team or clinician for treatment as appropriate This includes clinicians in the dental hospital andor medical practitioners Participants will be informed of this in the patient information sheet and provide their consent In the unlikely event of treatment failure patients will be offered root canal treatment to provide definite care
3 Biological samples including dentin saliva oral swabs and blood will be acquired during restorative procedures and stored at -80C for optimal preservation Proteomic analysis will be performed using high-resolution liquid chromatography-tandem mass spectrometry LC-MSMS on dentin and saliva samples while enzyme assays will quantify protease activities particularly focusing on matrix metalloproteinases MMPs Bacterial enumeration will be conducted using qPCR Quantitative Polymerase Chain Reaction techniques offering both specificity and sensitivity in microbial identification correlated with the microbial community composition as determined by sequencing approaches Biological specimen will be obtained by trained competent dentally-trained operators trained post-graduate students who are treating patients routinely at Guys clinics as they are part of dental team Biological specimen will be stored and managed within HTA Human Tissue Authorization-approved freezers on site
PhDDoctor of Philosophy student is the involved with the samples transfer and analysis where she is going to take training and certificates needed including HTA certificate
4 Radiation exposure will be limited to radiographs necessary in routine care No extra radiation will be given to patients as they are all routine of care radiographs at GSTT
5 Confidentiality will be ensured by Pseudo-anonymization which will be performed by assigning a code to the patients ID Identification number All data and decoding will be kept separately on two different password-protected computers at each site Access to the decoded data will be restricted to the chief investigator and academic supervisors until interim or final statistical analysis All patients will be assured confidentiality and no data submitted to statistical analysis will be traceable back to an individual patient
The clinical trial will adhere to the principles of the Declaration of Helsinki Patients may withdraw from the study at any time and their clinical care will be unaffected
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