Deep Caries Lesion of Pemanent TeethNCT07765810
Outcome of Selective Caries Removal Performed by Undergraduate Students
A study testing Selective caries removal to soft dentine and Selective Caries Removal to Firm/Leathery Dentine in people with Deep Caries Lesion of Pemanent Teeth, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Deep tooth decay can sometimes reach very close to the nerve of a tooth. Traditionally, dentists may remove all of the decayed tooth tissue, but removing too much tissue can increase the risk of exposing or damaging the nerve. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Deep Caries Lesion of Pemanent Teeth
- What is being tested?
- Selective caries removal to soft dentine and Selective Caries Removal to Firm/Leathery Dentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2025to Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients in good general health (ASA I or II).
- One permanent tooth with a deep carious lesion involving ≥ ¾ of the dentine on bitewing radiograph.
- Positive response to cold and/or electric pulp testing.
- Bite-wing radiographic evidence of a well-defined radiodense zone between the carious lesion and the pulp.
Who cannot join
- Irreversible pulpitis
- Need for post and core restoration
- Non restorable teeth
- Negative response to sensibility testing
- Inability to isolate the tooth via rubber dam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Caries Removal in Deep Carious Lesions of Permanent Teeth by Undergraduate Dental Students: A Prospective Clinical Study
Deep tooth decay can sometimes reach very close to the nerve of a tooth. Traditionally, dentists may remove all of the decayed tooth tissue, but removing too much tissue can increase the risk of exposing or damaging the nerve.
This study is looking at a more conservative way of treating deep tooth decay called selective removal of tooth decay. Instead of removing all the affected tissue close to the nerve, some of it is carefully left in place to help protect the nerve and preserve the tooth.
Read more
We will compare two ways of doing this. In one group, the dentist will remove the decay until softer tooth tissue remains near the nerve. In the other group, the dentist will remove more of the decay until firmer, leathery tooth tissue remains.
About 100 patients with deep tooth decay in permanent teeth will take part in the study. The treatment will be provided by trained fifth-year dental students under supervision and using standardized procedures.
After treatment, patients will be asked about any pain at 1, 3, and 7 days. The treated teeth will also be checked clinically and with dental X-rays at 6 and 12 months.
The purpose of the study is to find out whether either approach provides better outcomes while preserving the health of the tooth. The results may help dentists choose the most appropriate and conservative way to treat deep tooth decay and may also help improve dental student training.
Read the detailed description
This is a prospective, randomized clinical study evaluating two approaches to selective caries removal (SCR) for the management of deep carious lesions in permanent teeth. The study will compare selective caries removal to soft dentine with selective caries removal to firm/leathery dentine. The aim is to determine whether the texture of the dentine left over the pulp influences clinical and radiographic treatment outcomes.
Following approval by the Institutional Review Board, eligible patients will be recruited from the dental teaching clinics at Jordan University of Science and Technology (JUST). Written informed consent will be obtained from all participants before enrollment. Approximately 100 patients will be included, with one tooth per patient. Participants will be randomly allocated in a 1:1 ratio to receive selective caries removal to either soft dentine or firm/leathery dentine.
Selective caries removal will be performed under rubber dam isolation according to a standardized clinical protocol. Soft dentine will be defined as soft, wet, easily deformable dentine that can be readily removed with a hand instrument. Firm/leathery dentine will be defined as drier, rubbery, less compressible dentine that provides moderate resistance to excavation. Following caries removal, the cavity will be disinfected and restored using a standardized adhesive restorative procedure.
Treatment will be performed by fifth-year undergraduate dental students under the supervision of experienced dental specialists. Supervisors will be calibrated before the study using standardized clinical cases, including clinical photographs, radiographs, and videos. Cases will be distributed among supervisors to promote consistent clinical supervision and standardization of treatment.
Baseline information, including patient and tooth characteristics, pain history, and caries risk, will be recorded. Postoperative pain will be assessed at 1, 3, and 7 days after treatment. Clinical and radiographic examinations will be performed at 6 and 12 months to evaluate the condition and treatment outcome of the treated teeth.
The study will assess whether selective caries removal to soft dentine provides outcomes comparable to or different from selective caries removal to firm/leathery dentine. The findings may help determine the most appropriate extent of caries removal for deep lesions and provide evidence to support conservative caries management in undergraduate dental education.
- Conditions
- Deep Caries Lesion of Pemanent Teeth
- Being tested
- Selective caries removal to soft dentine, Selective Caries Removal to Firm/Leathery Dentine
- Keywords
- Caries, Pulpitis, Selective caries removal, Soft dentine, Leathery dentine, Outcome
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective caries removal to soft dentineProcedure or surgery
Selective removal of carious dentine until soft dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
Selective Caries Removal to Firm/Leathery DentineProcedure or surgery
Selective removal of carious dentine until firm/leathery dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
| Study group | Role | What they receive |
|---|---|---|
| Selective craies removal to soft dentine | Experimental | Dental caries will be cleaned from peripheries and soft dentine will be left over the pulpal wall Receives: Procedure: Selective caries removal to soft dentine |
| Selective caries removal to firm dentine | Active comparator | Dental caries will be cleaned from peripheries and firm dentine will be left over the pulpal wall Receives: Procedure: Selective Caries Removal to Firm/Leathery Dentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Treatment success will be assessed based on the clinical and radiographic condition of the treated tooth. Clinical success will include absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, or other signs of pulpal or periapical disease. Radiographic success will be defined by tooth vitality and response to sensibility testing and absence of periapical pathology on follow-up radiographs.
Measured: 6, 12, 24, 36 months
Secondary outcomes (2)
Postopertive pain
Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the most severe pain. Participants will report their pain intensity following treatment, and any analgesic use during the postoperative period will also be recorded.
Measured: 1, 3, 7 days postoperative
Tooth survival
Tooth survival will be assessed by determining whether the treated tooth remains present and functional during the follow-up period. Tooth survival will be defined as retention of the treated tooth without extraction. The need for additional endodontic treatment or other major intervention will also be recorded.
Measured: 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Caries Lesion of Pemanent TeethStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. Each participant will receive selective caries removal in one permanent tooth, either to soft dentine or to firm/leathery dentine. The two groups will be followed prospectively and compared for postoperative pain and clinical and radiographic treatment outcomes.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Nessrin Taha, King Abdullah University Hospital
- Investigators
- Nessrin Taha, DClinDent, PhD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765810
- Sponsor's protocol ID
- 494/2025
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared publicly due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the Principal Investigator following publication of the study results, in accordance with university policies and applicable ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Caries Removal in Deep Carious Lesions of Permanent Teeth by Undergraduate Dental Students: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07765810
- Acronym / sponsor ID
- 494/2025
- Conditions
- Deep Caries Lesion of Pemanent Teeth
- Keywords
- Caries, Pulpitis, Selective caries removal, Soft dentine, Leathery dentine, Outcome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 14 Aug 2026 (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.
Deep tooth decay can sometimes reach very close to the nerve of a tooth. Traditionally, dentists may remove all of the decayed tooth tissue, but removing too much tissue can increase the risk of exposing or damaging the nerve.
This study is looking at a more conservative way of treating deep tooth decay called selective removal of tooth decay. Instead of removing all the affected tissue close to the nerve, some of it is carefully left in place to help protect the nerve and preserve the tooth.
We will compare two ways of doing this. In one group, the dentist will remove the decay until softer tooth tissue remains near the nerve. In the other group, the dentist will remove more of the decay until firmer, leathery tooth tissue remains.
About 100 patients with deep tooth decay in permanent teeth will take part in the study. The treatment will be provided by trained fifth-year dental students under supervision and using standardized procedures.
After treatment, patients will be asked about any pain at 1, 3, and 7 days. The treated teeth will also be checked clinically and with dental X-rays at 6 and 12 months.
The purpose of the study is to find out whether either approach provides better outcomes while preserving the health of the tooth. The results may help dentists choose the most appropriate and conservative way to treat deep tooth decay and may also help improve dental student training.
Detailed description
This is a prospective, randomized clinical study evaluating two approaches to selective caries removal (SCR) for the management of deep carious lesions in permanent teeth. The study will compare selective caries removal to soft dentine with selective caries removal to firm/leathery dentine. The aim is to determine whether the texture of the dentine left over the pulp influences clinical and radiographic treatment outcomes.
Following approval by the Institutional Review Board, eligible patients will be recruited from the dental teaching clinics at Jordan University of Science and Technology (JUST). Written informed consent will be obtained from all participants before enrollment. Approximately 100 patients will be included, with one tooth per patient. Participants will be randomly allocated in a 1:1 ratio to receive selective caries removal to either soft dentine or firm/leathery dentine.
Selective caries removal will be performed under rubber dam isolation according to a standardized clinical protocol. Soft dentine will be defined as soft, wet, easily deformable dentine that can be readily removed with a hand instrument. Firm/leathery dentine will be defined as drier, rubbery, less compressible dentine that provides moderate resistance to excavation. Following caries removal, the cavity will be disinfected and restored using a standardized adhesive restorative procedure.
Treatment will be performed by fifth-year undergraduate dental students under the supervision of experienced dental specialists. Supervisors will be calibrated before the study using standardized clinical cases, including clinical photographs, radiographs, and videos. Cases will be distributed among supervisors to promote consistent clinical supervision and standardization of treatment.
Baseline information, including patient and tooth characteristics, pain history, and caries risk, will be recorded. Postoperative pain will be assessed at 1, 3, and 7 days after treatment. Clinical and radiographic examinations will be performed at 6 and 12 months to evaluate the condition and treatment outcome of the treated teeth.
The study will assess whether selective caries removal to soft dentine provides outcomes comparable to or different from selective caries removal to firm/leathery dentine. The findings may help determine the most appropriate extent of caries removal for deep lesions and provide evidence to support conservative caries management in undergraduate dental education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. Each participant will receive selective caries removal in one permanent tooth, either to soft dentine or to firm/leathery dentine. The two groups will be followed prospectively and compared for postoperative pain and clinical and radiographic treatment outcomes.
| Arm | Type | Receives |
|---|---|---|
| Selective craies removal to soft dentine | Experimental | Procedure: Selective caries removal to soft dentineDental caries will be cleaned from peripheries and soft dentine will be left over the pulpal wall |
| Selective caries removal to firm dentine | Active comparator | Procedure: Selective Caries Removal to Firm/Leathery DentineDental caries will be cleaned from peripheries and firm dentine will be left over the pulpal wall |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients in good general health (ASA I or II).
- One permanent tooth with a deep carious lesion involving ≥ ¾ of the dentine on bitewing radiograph.
- Positive response to cold and/or electric pulp testing.
- Bite-wing radiographic evidence of a well-defined radiodense zone between the carious lesion and the pulp.
Key exclusion criteria (5 listed)
- Irreversible pulpitis
- Need for post and core restoration
- Non restorable teeth
- Negative response to sensibility testing
- Inability to isolate the tooth via rubber dam
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 to soft dentineSelective removal of carious dentine until soft dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration. | Procedure or surgery | Selective craies removal to soft dentine |
| Selective Caries Removal to Firm/Leathery DentineSelective removal of carious dentine until firm/leathery dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration. | Procedure or surgery | Selective caries removal to firm dentine |
Primary outcome
Success
Time frame: 6, 12, 24, 36 months
Treatment success will be assessed based on the clinical and radiographic condition of the treated tooth. Clinical success will include absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, or other signs of pulpal or periapical disease. Radiographic success will be defined by tooth vitality and response to sensibility testing and absence of periapical pathology on follow-up radiographs.
2 secondary outcomes
Postopertive pain
Time frame: 1, 3, 7 days postoperative
Tooth survival
Time frame: 12, 24, 36 months
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 14 Aug 2026.
- Publication by the study chair on the topic of selcetive caries removal that can be used as a refernce for the background and methodologyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared publicly due to institutional regulations regarding data access and participant confidentiality. Requests for access to study data may be considered by the Principal Investigator following publication of the study results, in accordance with university policies and applicable ethical requirements.
Related trials for Deep Caries Lesion of Pemanent Teeth
Active, not recruiting
A Comparative Clinical Study Assessing Dentin Thickness and Discoloration in Deep Carious Lesions Treated With Biodentine Alone Versus Diode Laser Pre-treatment Followed by Biodentine
Patients With Deep Carious Lesions, Deep Caries Lesion of Pemanent Teeth
Not yet recruiting
Adjustment Period for Partial Crowns
Deep Caries Lesion of Pemanent Teeth
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. This study is not recruiting at the moment.
Nessrin Taha, DClinDent, PhD study chair
Jordan University of Science and Technology
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 caries removal to soft dentine and Selective Caries Removal to Firm/Leathery Dentine in people with Deep Caries Lesion of Pemanent Teeth, run by King Abdullah University Hospital at 1 site in Jordan.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 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 Jordan. 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?
Success (time frame: 6, 12, 24, 36 months). 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 14 Aug 2026.