Outcome of Selective Caries Removal Performed by Undergraduate Students

NCT07765810 | Active Not Recruiting

• 1 other identifier: 494/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Deep Caries Lesion of Pemanent Teeth

Keywords

Caries; Pulpitis; Selective caries removal; Soft dentine; Leathery dentine; Outcome

Outcome Measures

Primary Outcomes (1)

• 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.

  6, 12, 24, 36 months

Secondary Outcomes (2)

• Postopertive pain

  1, 3, 7 days postoperative

• Tooth survival

  12, 24, 36 months

Study Arms (2)

Selective craies removal to soft dentine

EXPERIMENTAL

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 caries removal to firm dentine

ACTIVE COMPARATOR

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

Interventions

Selective caries removal to soft dentine PROCEDURE

Selective removal of carious dentine until soft dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.

Selective craies removal to soft dentine

Selective Caries Removal to Firm/Leathery Dentine PROCEDURE

Selective removal of carious dentine until firm/leathery dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.

Selective caries removal to firm dentine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan university of science and Technology

Irbid, 3030, Jordan

Location

Related Links

• Publication by the study chair on the topic of selcetive caries removal that can be used as a refernce for the background and methodology

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nessrin Taha, DClinDent, PhD

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Endodontics

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

JO (1)