Deep CariesNCT05816525
The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue
An observational study of Deep Caries and Pulpitis Reversible, run by University of Helsinki at 1 site in Finland.
Trial summary
The goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries, Pulpitis Reversible, Pulp Hyperemia
- What is being tested?
- Partial removal of carious tissue and Final restoration
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 21 Apr 2023to 31 Dec 2027
- Phase
- Observational
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The first 100 consecutive patients that have entered the dental clinics involved, fulfilling the inclusion criteria, have given their informed consent, and have responded to the questionnaire after 7 days post-treatment, will be recruited.
Who may be able to join
- the patient is communicating in the Finnish or English language
- a deep primary or secondary carious lesion in 1st or 2nd premolar or molar on occlusal or proximal surface, extending to the deepest quarter of dentine assessed from the radiograph
- asymptomatic or symptoms not more severe than reversible pulpitis (mild pulpitis according to the new pulpitis classification proposal)
- pulp responding to the electric pulp testing and cold testing
- the periodontal stage of the tooth should be I or II.
- In case the patient has several teeth fulfilling the inclusion criteria, the one with the deepest lesion and/or most severe symptoms is chosen to the study.
Who cannot join
- general medical condition which makes the patient more susceptible to odontogenic infection complications
- pregnancy, breastfeeding
- mental retardation, memory disorder
- the carious lesion is extending to more than three surfaces or to both proximal surfaces
- the tooth has previous other filling(s): i) extending deeper than to the outer third of dentine; or ii) the filling is larger than Class I or II; or iii) Class II filling is not restricted to enamel; or iv) the filling has secondary/residual caries
- the tooth is not restorable
Show all 11Show fewer
- periapical changes in the periapical radiograph
- sensitivity to percussion; swelling; sinus tract; increased mobility; resorption
- furcal lesion more severe than Class I
- ongoing orthodontic treatment
- declining to sign the written consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Western Uusimaa Wellbeing Services County
Espoo
Katri Croft, DDS
Sari Kervanto-Seppälä, DDS, PhD
About this study
The goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. The main questions the study aims to answer are:
- Do preoperative symptoms affect the outcome?
- Does the depth of the carious lesion affect the outcome?
Read more
One hundred participants will be recruited. Patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. Partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the Finnish national treatment guidelines. Participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. The teeth will then be followed up for 12-24 months.
The null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.
- Conditions
- Deep Caries, Pulpitis Reversible, Pulp Hyperemia
- Being tested
- Partial removal of carious tissue, Final restoration
- Keywords
- vital pulp therapy, deep carious lesion, selective carious tissue removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial removal of carious tissueProcedure or surgery
Nonselective carious tissue excavation will be performed in the periphery of the cavity to achieve a good marginal seal. In the pulpal wall selective, partial carious tissue excavation is performed to the soft dentin, removing tissue only the amount that is necessary for placing the restoration. The tooth is restored with high-viscosity glass-ionomer cement.
Final restorationProcedure or surgery
The teeth will be restored with composite resin after 12 months follow up, if the tooth is asymptomatic, responds to sensibility tests and there are no periapical changes radiographically. Glass ionomer cement will be only partially removed to create space for the final restoration.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success at the follow up
Symptoms and the clinical condition of the tooth will be evaluated at the follow up. In particular, the response of the tooth to both cold and EPT will be tested. In addition, a periapical radiograph will be taken. An asymptomatic tooth that responds positively to sensibility testing (both cold and EPT) and has no signs of infection clinically or in a periapical radiograph, is considered a success.
Measured: 12-24 months
Secondary outcomes (2)
Symptoms 7 days post-treatment
The participants will be asked to fill in an electronic questionnaire 7 days after the partial carious tissue removal. The participants will be asked whether the tooth was asymptomatic or symptomatic i) pre-treatment and ii) on the day of treatment after local anesthesia, iii) 3 days post-treatment and iv) 7 days post-treatment. Multi-choice questions will be used to find out about the nature and intensity of pain.
Measured: 7 days
Pain severity using Visual Analogue Scale (VAS) 7 days post-treatment
The participants will be asked to fill in an electronic Visual Analogue Scale (VAS) 7 days after the partial carious tissue removal. VAS will be used to assess the severity of pain experienced. The scale will be 0-10, 0 indicating no pain and 10 indicating worst pain imaginable. The participants will be asked about pain severity i) pre-treatment, ii) on the day of treatment after local anesthesia, iii) 3 days post-treatment and iv) 7 days post-treatment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start21 Apr 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katri Croft, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816525
- Sponsor's protocol ID
- PARTIALCARIESREMOVAL
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
PubMed 28776717
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue
- ClinicalTrials.gov ID
- NCT05816525
- Acronym / sponsor ID
- PARTIALCARIESREMOVAL
- Conditions
- Deep Caries, Pulpitis Reversible, Pulp Hyperemia
- Keywords
- vital pulp therapy, deep carious lesion, selective carious tissue removal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Apr 2023 (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 goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. The main questions the study aims to answer are:
- Do preoperative symptoms affect the outcome?
- Does the depth of the carious lesion affect the outcome?
One hundred participants will be recruited. Patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. Partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the Finnish national treatment guidelines. Participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. The teeth will then be followed up for 12-24 months.
The null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The first 100 consecutive patients that have entered the dental clinics involved, fulfilling the inclusion criteria, have given their informed consent, and have responded to the questionnaire after 7 days post-treatment, will be recruited.
Key inclusion criteria (6 listed)
- the patient is communicating in the Finnish or English language
- a deep primary or secondary carious lesion in 1st or 2nd premolar or molar on occlusal or proximal surface, extending to the deepest quarter of dentine assessed from the radiograph
- asymptomatic or symptoms not more severe than reversible pulpitis (mild pulpitis according to the new pulpitis classification proposal)
- pulp responding to the electric pulp testing and cold testing
- the periodontal stage of the tooth should be I or II.
Key exclusion criteria (11 listed)
- general medical condition which makes the patient more susceptible to odontogenic infection complications
- pregnancy, breastfeeding
- mental retardation, memory disorder
- the carious lesion is extending to more than three surfaces or to both proximal surfaces
- the tooth has previous other filling(s): i) extending deeper than to the outer third of dentine; or ii) the filling is larger than Class I or II; or iii) Class II filling is not restricted to enamel; or iv) the filling has secondary/residual caries
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 |
|---|---|---|
| Partial removal of carious tissueNonselective carious tissue excavation will be performed in the periphery of the cavity to achieve a good marginal seal. In the pulpal wall selective, partial carious tissue excavation is performed to the soft dentin, removing tissue only the amount that is necessary for placing the restoration. The tooth is restored with high-viscosity glass-ionomer cement. | Procedure or surgery | – |
| Final restorationThe teeth will be restored with composite resin after 12 months follow up, if the tooth is asymptomatic, responds to sensibility tests and there are no periapical changes radiographically. Glass ionomer cement will be only partially removed to create space for the final restoration. | Procedure or surgery | – |
Primary outcome
Clinical and radiographic success at the follow up
Time frame: 12-24 months
Symptoms and the clinical condition of the tooth will be evaluated at the follow up. In particular, the response of the tooth to both cold and EPT will be tested. In addition, a periapical radiograph will be taken. An asymptomatic tooth that responds positively to sensibility testing (both cold and EPT) and has no signs of infection clinically or in a periapical radiograph, is considered a success.
2 secondary outcomes
Symptoms 7 days post-treatment
Time frame: 7 days
Pain severity using Visual Analogue Scale (VAS) 7 days post-treatment
Time frame: 7 days
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 22 Apr 2026.
- Background: PubMed 28776717Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Caries and Pulpitis Reversible, run by University of Helsinki at 1 site in Finland.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Apr 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 Finland. 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?
Contact Katri Croft, DDS (+358407367250, katri.croft@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographic success at the follow up (time frame: 12-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816525, which also lists 1 linked publication.
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 22 Apr 2026.