Outcome of Selective Caries Removal Performed by Undergraduate Students

August 10, 2026 updated by: Nessrin Taha, King Abdullah University Hospital

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 3030
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Irreversible pulpitis
  • Need for post and core restoration
  • Non restorable teeth
  • Negative response to sensibility testing
  • Inability to isolate the tooth via rubber dam

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Selective craies removal to soft dentine
Dental caries will be cleaned from peripheries and soft dentine will be left over the pulpal wall
Procedure: Selective caries removal to soft dentine
Selective removal of carious dentine until soft dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
Active Comparator: Selective caries removal to firm dentine
Dental caries will be cleaned from peripheries and firm dentine will be left over the pulpal wall
Procedure: Selective Caries Removal to Firm/Leathery Dentine
Selective removal of carious dentine until firm/leathery dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6, 12, 24, 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postopertive pain
Time Frame: 1, 3, 7 days postoperative
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.
1, 3, 7 days postoperative
Tooth survival
Time Frame: 12, 24, 36 months
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.
12, 24, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Abdullah University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jordan University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nessrin Taha, DClinDent, PhD, Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 494/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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