Deep CariesRCT-SNCRNCT06378814
Outcome of Selective & Nonselective Caries Removal in Permanent Teeth
A study testing Selective Caries Removal (No Pulp Exposure), Non-Selective Caries Removal (No Pulp exposure) and Partial Pulpotomy (Pulp Exposed) in people with Deep Caries and Carious Exposure of Pulp, run by King's College London.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Caries, Carious Exposure of Pulp
- What is being tested?
- Selective Caries Removal (No Pulp Exposure), Non-Selective Caries Removal (No Pulp exposure) and Partial Pulpotomy (Pulp Exposed)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dental patients from routine dental care at ADC (Acute Dental Care) clinics, both undergraduate and postgraduate dental clinics in Guy's Hospital.
- Both male and female individuals aged 18 years and older.
- Capable of providing informed consent.
- Generally, in good overall health from a medical standpoint.
- Possess at least one molar or premolar tooth exhibiting a clinically significant deep carious lesion, with or without carious pulp exposure.
- Displaying signs and symptoms indicative of a normal pulp or reversible pulpitis.
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- positive response to the cold test (refrigerated gas).
- Absence of spontaneous pain.
- Absence of periapical lesions, as determined by routine radiographic examination
Who cannot join
- Presence of fistulas or swelling.
- Involvement of anterior teeth.
- Evidence of external or internal root resorption.
- Multiple teeth with carious lesions within the same quadrant.
- Pregnancy in women.
- Patients under the age of 18.
Show all 15Show fewer
- Individuals unable to provide informed consent.
- Patients who have received antibiotics in the preceding month.
- Immunocompromised patients.
- Teeth with tooth surface loss resulting from traumatic parafunctional habits or teeth displaying craze lines.
- Caries located beneath the gingival margin .
- Teeth affected by periodontal issues, characterized by bone loss or severe gingival recession.
- Teeth with pulp exposure where operators cannot achieve hemostasis after applying a cotton pellet soaked with 2.5% sodium hypochlorite (NaOCl) for three cycles, with each cycle consisting of a 2-minute application of NaOCl.
- People with difficulty to understand the clinical trial concept, procedure and details including language barrier.
- participants who are involved in other research at the same period of our study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Clinical Trial of Treatment Outcomes of Selective Versus Nonselective Caries Removal in Deep Carious Lesions in Permanent Teeth.
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 health(vitality).
Read more
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 Guy's 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.
Read the detailed description
The clinical trial aims to compare the outcomes of non-selective versus selective caries removal.
- Recruiting patients This will involve symptomatic patients attending Guy's and St Thomas's 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.
- 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 and/or 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.
- Biological samples, including dentin, saliva, oral swabs, and blood, will be acquired during restorative procedures and stored at -80°C for optimal preservation. Proteomic analysis will be performed using high-resolution liquid chromatography-tandem mass spectrometry (LC-MS/MS) 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 Guy's clinics as they are part of dental team). Biological specimen will be stored and managed within HTA (Human Tissue Authorization)-approved freezers on site. PhD(Doctor 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.
- 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.
- Confidentiality will be ensured by Pseudo-anonymization which will be performed by assigning a code to the patient's 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.
- Conditions
- Deep Caries, Carious Exposure of Pulp
- Being tested
- Selective Caries Removal (No Pulp Exposure), Non-Selective Caries Removal (No Pulp exposure), Partial Pulpotomy (Pulp Exposed)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Caries Removal (No Pulp Exposure)Procedure or surgery
Also called SCR
Caries excavation technique where clinician leaves carious tissue so close to pulp
Non-Selective Caries Removal (No Pulp exposure)Procedure or surgery
Also called NSCR
Complete caries removal even in areas so close to pulp
Partial Pulpotomy (Pulp Exposed)Procedure or surgery
Also called Miniature Pulpotomy
In caes of Pulp exposure Amputation of inflamed coronal pulp and capping of remaining vital tissue
| Study group | Role | What they receive |
|---|---|---|
| Selective Caries Removal | Experimental | This process will be conducted under an operating microscope to ensure precise removal of carious dentin on cavity walls. Only disorganized carious dentin on the cavity floor will be removed using hand instruments in the control group which is SCR group Receives: Procedure: Selective Caries Removal (No Pulp Exposure); Procedure: Partial Pulpotomy (Pulp Exposed) |
| Non selective caries removal | Experimental | On the other hand, removal of carious dentin on cavity floor will be completely up to hard sound dentine in NSCR group. Receives: Procedure: Non-Selective Caries Removal (No Pulp exposure); Procedure: Partial Pulpotomy (Pulp Exposed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention.
This study aims to compare between reported success rate (maintained pulp vitality) in cases of deep caries lesion when treated by by Selective caries removal and non-selective caries removal.
Pulp sensibility tests will be used to assess the response of the pulp to external stimuli (pulp vitality).
The success rate will be calculated as the ratio of cases with maintained pulp vitality to the total treated cases in each group.
Measured: After One year
Secondary outcomes (2)
Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment
The study aims to evaluate periapical health in the treatment of deep caries lesions using selective caries removal and partial pulpotomy. The assessment will be done using the Periapical Index Score. The Periapical Index Score is a standardized scoring system based on radiographic findings, allowing for the identification of healing or failure outcomes. The Periapical Index (PAI) score is a radiographic scale used in endodontics to evaluate the severity of periapical lesions. The scale ranges from 1 to 5, with higher scores indicating more severe periapical pathology. A score of 1 represents no changes, while a score of 5 indicates extensive destruction of periapical tissues. In summary, higher PAI scores correspond to worse outcomes, indicating greater periapical pathology, while lower scores reflect healthier periapical regions.
Measured: At 1, 3 and 5 years after the intervention
Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy
This study aims to assess the impact of selective caries removal and partial pulpotomy on the quality of life of participants with deep caries lesions. Quantitative assessment will be done using the Oral Health Impact Profile-14 (OHIP-14). The Oral Health Impact Profile-14 (OHIP-14) is a questionnaire used to measure how oral health affects a person's quality of life. It consists of 14 items and assesses various aspects of oral health-related impact, such as physical discomfort, functional limitations, psychological discomfort, and social disability. The scores on the OHIP-14 range from 0 to 56, with higher scores indicating a greater negative impact on quality of life. In summary, higher OHIP-14 scores signify a worse outcome, indicating a higher burden of oral health problems and a greater impact on daily life functioning. Lower scores indicate a better outcome, reflecting a lesser impact of oral health issues on overall quality of life.
Measured: after one year of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arms parallel randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Francesco Mannoci, Professor, Principal investigator, professor of endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378814
- Sponsor's protocol ID
- IRAS N335444
- Acronym
- RCT-SNCR
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Treatment Outcomes of Selective Versus Nonselective Caries Removal in Deep Carious Lesions in Permanent Teeth.
- ClinicalTrials.gov ID
- NCT06378814
- Acronym / sponsor ID
- RCT-SNCR / IRAS N335444
- Conditions
- Deep Caries, Carious Exposure of Pulp
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 health(vitality).
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 Guy's 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.
- Recruiting patients This will involve symptomatic patients attending Guy's and St Thomas's 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.
- 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 and/or 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.
- Biological samples, including dentin, saliva, oral swabs, and blood, will be acquired during restorative procedures and stored at -80°C for optimal preservation. Proteomic analysis will be performed using high-resolution liquid chromatography-tandem mass spectrometry (LC-MS/MS) 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 Guy's clinics as they are part of dental team). Biological specimen will be stored and managed within HTA (Human Tissue Authorization)-approved freezers on site. PhD(Doctor 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.
- 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.
- Confidentiality will be ensured by Pseudo-anonymization which will be performed by assigning a code to the patient's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two arms parallel randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Selective Caries Removal | Experimental | Procedure: Selective Caries Removal (No Pulp Exposure), Procedure: Partial Pulpotomy (Pulp Exposed)This process will be conducted under an operating microscope to ensure precise removal of carious dentin on cavity walls. Only disorganized carious dentin on the cavity floor will be removed using hand instruments in the control group which is SCR group |
| Non selective caries removal | Experimental | Procedure: Non-Selective Caries Removal (No Pulp exposure), Procedure: Partial Pulpotomy (Pulp Exposed)On the other hand, removal of carious dentin on cavity floor will be completely up to hard sound dentine in NSCR group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Dental patients from routine dental care at ADC (Acute Dental Care) clinics, both undergraduate and postgraduate dental clinics in Guy's Hospital.
- Both male and female individuals aged 18 years and older.
- Capable of providing informed consent.
- Generally, in good overall health from a medical standpoint.
- Possess at least one molar or premolar tooth exhibiting a clinically significant deep carious lesion, with or without carious pulp exposure.
Key exclusion criteria (15 listed)
- Presence of fistulas or swelling.
- Involvement of anterior teeth.
- Evidence of external or internal root resorption.
- Multiple teeth with carious lesions within the same quadrant.
- Pregnancy in women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Caries Removal (No Pulp Exposure)Also: SCRCaries excavation technique where clinician leaves carious tissue so close to pulp | Procedure or surgery | Selective Caries Removal |
| Non-Selective Caries Removal (No Pulp exposure)Also: NSCRComplete caries removal even in areas so close to pulp | Procedure or surgery | Non selective caries removal |
| Partial Pulpotomy (Pulp Exposed)Also: Miniature PulpotomyIn caes of Pulp exposure Amputation of inflamed coronal pulp and capping of remaining vital tissue | Procedure or surgery | Non selective caries removal, Selective Caries Removal |
Primary outcome
To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention.
Time frame: After One year
This study aims to compare between reported success rate (maintained pulp vitality) in cases of deep caries lesion when treated by by Selective caries removal and non-selective caries removal. Pulp sensibility tests will be used to assess the response of the pulp to external stimuli (pulp vitality). The success rate will be calculated as the ratio of cases with maintained pulp vitality to the total treated cases in each group.
2 secondary outcomes
Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment
Time frame: At 1, 3 and 5 years after the intervention
Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy
Time frame: after one year of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
Related trials for Deep Caries
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Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
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"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Mannoci, Professor principal investigator
professor of endodontics
Questions about this trial
What is this clinical trial studying?
A study testing Selective Caries Removal (No Pulp Exposure), Non-Selective Caries Removal (No Pulp exposure) and Partial Pulpotomy (Pulp Exposed) in people with Deep Caries and Carious Exposure of Pulp, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Mannoci, Professor (02011881573, francesco.mannocci@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention. (time frame: After One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.