Outcome of Selective Caries Removal Performed by Undergraduate Students
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Irbid, Jordanien, 3030
- Jordan University of Science and Technology
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Selective craies removal to soft dentine
Dental caries will be cleaned from peripheries and soft dentine will be left over the pulpal wall
|
Selective removal of carious dentine until soft dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
|
|
Aktiv komparator: Selective caries removal to firm dentine
Dental caries will be cleaned from peripheries and firm dentine will be left over the pulpal wall
|
Selective removal of carious dentine until firm/leathery dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Success
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postopertive pain
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Nessrin Taha, DClinDent, PhD, Jordan University of Science and Technology
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 494/2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .