Dental CariesSELECTNCT06944028
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
A study testing Selective excavation and Stepwise excavation in people with Dental Caries and Dental Cavities, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this clinical trial is to evaluate and compare the outcomes of selective carious tissue removal versus stepwise carious tissue removal in young permanent teeth with deep carious lesions. The primary follow-up will be conducted 1 year after treatment to assess success. Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Dental Caries, Dental Cavities
- What is being tested?
- Selective excavation and Stepwise excavation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 31 Dec 2029
- 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 8 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 8- 19 years (last December the year they turn 19 years) A fully erupted molar or pre-molar teeth with dental caries (class I or class II) extending to more than 2/3 of the dentine thickness (and on the bitewing radiograph showing a radiodense zone separating the pulp from the demineralized dentine).
- Bitewing radiograph has been taken as part of the ordinary dental examination Available for recall at least for 1 year.
Who cannot join
- Extraction is planned of the tooth with deep caries in the future with expected spontaneous gap closure.
- If the carious tooth shows sign or symptoms of irreversible pulp pathology or loss of vitality including:
- Presence of a sinus tract (fistula)
- Tenderness to percussion
- Buccal tenderness
- Severe sensitivity
Show all 10Show fewer
- Evidence of pathology on a periapical radiograph (if radiograph is clinically justified and performed)
- No written informed consent.
- Medical condition requiring special considerations with regard of the dental management
- Dental treatment cannot be performed adequate due to lack cooperation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions (SELECT): A Randomized Controlled Trial in a Practice-Based Research Network
The purpose of this clinical trial is to evaluate and compare the outcomes of selective carious tissue removal versus stepwise carious tissue removal in young permanent teeth with deep carious lesions. The primary follow-up will be conducted 1 year after treatment to assess success. A secondary follow-up will take place 3 years post-treatment, utilizing data from dental registries and dental records. The study is a randomized controlled trial conducted within a practice-based research network.
Read the detailed description
The SELECT compares selective carious tissue removal and stepwise excavation in young permanent teeth with deep carious lesions. Unlike the traditional approach of total caries excavation-still widely practiced by dentists-the study implements minimally invasive methods in clinical settings. Conducted within a practice-based research network (PBRN), the study ensures that its findings are highly relevant to real-world clinical environments. Targeting young permanent teeth, a population critical for long-term dental health, the study has a robust randomized controlled trial (RCT) design. Its long follow-up period includes a clinical assessments at 1 year, and at 3 years using dental registry data/dental records. The focus on minimally invasive techniques aligns with contemporary trends in conservative dentistry, and the findings have the potential to inform future guidelines, advancing evidence-based and sustainable treatment practices.
Aim: The aim of the SELECT study is to compare the clinical and long-term outcomes of selective carious tissue removal versus stepwise excavation in managing deep carious lesions in young permanent teeth. The study aims to determine which method is more effective in preserving tooth vitality, reducing complications, and supporting sustainable dental health. The implementation of minimally invasive methods in routine dental practice is a key component of this study, emphasizing the importance of patient-centered and less invasive care.
Selection of participants: Participants will be recruited through the PBRN and all eligible patients will be considered if they comply with the clearly defined inclusion and exclusion criteria.
Statistical plan and data analysis: The sample size calculations is based on the statistical power to reject the null hypothesis H0" No difference between treatment types" at a 5% risk level of type I error. The sample size for each treatment group is determined to be 333 participants based on the primary outcome, with a primary follow-up period of 1 to 1,5 year including an attrition rate of 20%. The success probability for stepwise excavation is set at 90%, with a risk difference of +6 percentage points for selective excavation. The study is powered with a type-I error of 5% and a type-II error of 20%. For the follow-up data after 2-3 years, a base success probability of 80% for stepwise excavation was assumed and a risk difference of +10% for selective excavation rending for a sample size of 392 patients. The outcome will be a vital tooth without pain as a binary variable indicating a successful or unsuccessful treatment and a logistic regression analysis will be performed.
Randomization: Only one deep caries lesion per participant will be randomized. The trial will use block randomization.
Blinding: Blinding of the dental team performing the dental treatment or the patient is not possible as there is a one-visit or a two-visit procedure. The statistical analyses will be performed blinded.
Discontinuation and withdrawal: If a patient does not show up for an examination or treatment an effort will be made to reschedule for the visit and finding the reason for not showing up. But the participation is on a voluntary basis and the participant can chose to leave the study at any time. To facilitate the follow-up examination, there is some flexibility in the follow up period. If the patient fail to attend the scheduled appointment, at least one more appointment will be offered and preceded with a phone-call. Loss of follow up has been accounted for in the calculation of sample size
- Conditions
- Dental Caries, Dental Cavities
- Being tested
- Selective excavation, Stepwise excavation
- Keywords
- SELECT, stepwise excavation, selective excavation, deep dental caries lesions, young permanent teeeth
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective excavationProcedure or surgery
Partial removal of carious dentine, soft carious tissue is intentionally left over the pulp to avoid exposure. The peripheral enamel and dentine are prepared to hard dentine, and a permanent restoration is placed on the tooth.
Stepwise excavationProcedure or surgery
Partial removal of carious dentine is performed, soft dentine is intentionally left over the pulp to avoid exposure. The peripheral enamel and dentine are prepared to hard dentine, application of a provisional restoration. After approximately 3-5 months, the provisional restoration is removed, and any remaining carious dentine is further removed until firm dentine is reached. A permanent restoration is then applied.
| Study group | Role | What they receive |
|---|---|---|
| Selective excavation | Experimental | One visit procedure Receives: Procedure: Selective excavation |
| Stepwise excavation-two visit procedure | Active comparator | Two-visit procedure Receives: Procedure: Stepwise excavation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained tooth vitality
The examining dentist will aggregate a combination of clinical tests and radiographic findings that need to be fulfilled, to assess the outcome: sustained tooth vitality.
All assessments will be recorded separately. The following measures will be recorded: positive response to cold test, absence of fistula or abscess, absence of tenderness on percussion, no evidence of pulp necrosis based on a periapical radiograph (if clinically justified and performed), no root filling.
Additionally, the examining dentist will document which tests have been performed to justify the assessment.
Measured: 1-1,5 years after baseline
Secondary outcomes (5)
Health economic
Costs (direct and indirect)
Measured: Up to 3 years (after baseline)
Quality of life (Qol)
The EQ-5D-Y will be used to assess QoL. The EQ-5D-Y is a generic health-related quality of life (HRQoL) measure developed for youth from 8 years old that comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) 0-100 where higher score means better outcome. For more information: https://euroqol.org/wp-content/uploads/2023/11/Userguide-EQ5D-Y-23-07.pdf
Measured: 1 -1,5 years after baseline
No pain from tooth
Absence of pain from the tooth as reported by the patient and documented by the examining dentist.
Measured: 1-1,5 years after baseline
Sustained tooth without root canal treatment
Will be determined by the presence by a sustained tooth without root canal treatment at the follow up assessment
Measured: Up to 3 years (after baseline)
Tooth survival
Tooth still present at the follow-up assessment.
Measured: Up to 3 years (after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- A randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 666 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Folktandvården Stockholms län AB, Praktikertjanst AB
- Responsible party
- Principal investigator, Maria Anderson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944028
- Sponsor's protocol ID
- Dnr 2024-03717-01
- Other IDs
- selective excavation, SELECT
- Acronym
- SELECT
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions (SELECT): A Randomized Controlled Trial in a Practice-Based Research Network
- ClinicalTrials.gov ID
- NCT06944028
- Acronym / sponsor ID
- SELECT / Dnr 2024-03717-01
- Conditions
- Dental Caries, Dental Cavities
- Keywords
- SELECT, stepwise excavation, selective excavation, deep dental caries lesions, young permanent teeeth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 666 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Folktandvården Stockholms län AB, Praktikertjanst AB
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Apr 2025 (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.
The purpose of this clinical trial is to evaluate and compare the outcomes of selective carious tissue removal versus stepwise carious tissue removal in young permanent teeth with deep carious lesions. The primary follow-up will be conducted 1 year after treatment to assess success. A secondary follow-up will take place 3 years post-treatment, utilizing data from dental registries and dental records. The study is a randomized controlled trial conducted within a practice-based research network.
Detailed description
The SELECT compares selective carious tissue removal and stepwise excavation in young permanent teeth with deep carious lesions. Unlike the traditional approach of total caries excavation-still widely practiced by dentists-the study implements minimally invasive methods in clinical settings. Conducted within a practice-based research network (PBRN), the study ensures that its findings are highly relevant to real-world clinical environments. Targeting young permanent teeth, a population critical for long-term dental health, the study has a robust randomized controlled trial (RCT) design. Its long follow-up period includes a clinical assessments at 1 year, and at 3 years using dental registry data/dental records. The focus on minimally invasive techniques aligns with contemporary trends in conservative dentistry, and the findings have the potential to inform future guidelines, advancing evidence-based and sustainable treatment practices.
Aim: The aim of the SELECT study is to compare the clinical and long-term outcomes of selective carious tissue removal versus stepwise excavation in managing deep carious lesions in young permanent teeth. The study aims to determine which method is more effective in preserving tooth vitality, reducing complications, and supporting sustainable dental health. The implementation of minimally invasive methods in routine dental practice is a key component of this study, emphasizing the importance of patient-centered and less invasive care.
Selection of participants: Participants will be recruited through the PBRN and all eligible patients will be considered if they comply with the clearly defined inclusion and exclusion criteria.
Statistical plan and data analysis: The sample size calculations is based on the statistical power to reject the null hypothesis H0" No difference between treatment types" at a 5% risk level of type I error. The sample size for each treatment group is determined to be 333 participants based on the primary outcome, with a primary follow-up period of 1 to 1,5 year including an attrition rate of 20%. The success probability for stepwise excavation is set at 90%, with a risk difference of +6 percentage points for selective excavation. The study is powered with a type-I error of 5% and a type-II error of 20%. For the follow-up data after 2-3 years, a base success probability of 80% for stepwise excavation was assumed and a risk difference of +10% for selective excavation rending for a sample size of 392 patients. The outcome will be a vital tooth without pain as a binary variable indicating a successful or unsuccessful treatment and a logistic regression analysis will be performed.
Randomization: Only one deep caries lesion per participant will be randomized. The trial will use block randomization.
Blinding: Blinding of the dental team performing the dental treatment or the patient is not possible as there is a one-visit or a two-visit procedure. The statistical analyses will be performed blinded.
Discontinuation and withdrawal: If a patient does not show up for an examination or treatment an effort will be made to reschedule for the visit and finding the reason for not showing up. But the participation is on a voluntary basis and the participant can chose to leave the study at any time. To facilitate the follow-up examination, there is some flexibility in the follow up period. If the patient fail to attend the scheduled appointment, at least one more appointment will be offered and preceded with a phone-call. Loss of follow up has been accounted for in the calculation of sample size
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Selective excavation | Experimental | Procedure: Selective excavationOne visit procedure |
| Stepwise excavation-two visit procedure | Active comparator | Procedure: Stepwise excavationTwo-visit procedure |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged 8- 19 years (last December the year they turn 19 years) A fully erupted molar or pre-molar teeth with dental caries (class I or class II) extending to more than 2/3 of the dentine thickness (and on the bitewing radiograph showing a radiodense zone separating the pulp from the demineralized dentine).
- Bitewing radiograph has been taken as part of the ordinary dental examination Available for recall at least for 1 year.
Key exclusion criteria (10 listed)
- Extraction is planned of the tooth with deep caries in the future with expected spontaneous gap closure.
- If the carious tooth shows sign or symptoms of irreversible pulp pathology or loss of vitality including:
- Presence of a sinus tract (fistula)
- Tenderness to percussion
- Buccal tenderness
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 excavationPartial removal of carious dentine, soft carious tissue is intentionally left over the pulp to avoid exposure. The peripheral enamel and dentine are prepared to hard dentine, and a permanent restoration is placed on the tooth. | Procedure or surgery | Selective excavation |
| Stepwise excavationPartial removal of carious dentine is performed, soft dentine is intentionally left over the pulp to avoid exposure. The peripheral enamel and dentine are prepared to hard dentine, application of a provisional restoration. After approximately 3-5 months, the provisional restoration is removed, and any remaining carious dentine is further removed until firm dentine is reached. A permanent restoration is then applied. | Procedure or surgery | Stepwise excavation-two visit procedure |
Primary outcome
Sustained tooth vitality
Time frame: 1-1,5 years after baseline
The examining dentist will aggregate a combination of clinical tests and radiographic findings that need to be fulfilled, to assess the outcome: sustained tooth vitality. All assessments will be recorded separately. The following measures will be recorded: positive response to cold test, absence of fistula or abscess, absence of tenderness on percussion, no evidence of pulp necrosis based on a periapical radiograph (if clinically justified and performed), no root filling. Additionally, the examining dentist will document which tests have been performed to justify the assessment.
5 secondary outcomes
Health economic
Time frame: Up to 3 years (after baseline)
Quality of life (Qol)
Time frame: 1 -1,5 years after baseline
No pain from tooth
Time frame: 1-1,5 years after baseline
Sustained tooth without root canal treatment
Time frame: Up to 3 years (after baseline)
Tooth survival
Time frame: Up to 3 years (after baseline)
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 12 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective excavation and Stepwise excavation in people with Dental Caries and Dental Cavities, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained tooth vitality (time frame: 1-1,5 years after baseline). 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 12 Aug 2026.