Outcome of Selective & Nonselective Caries Removal in Permanent Teeth

NCT06378814 | Not Yet Recruiting

• 1 other identifier: IRAS N335444
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists. The aim of this trial is to compare the success rate of the non-selective caries removal (NSCR) and selective caries removal (SCR) in managing deep caries, as both methods are commonly used in clinical practice. This study will be a randomized controlled trial, with participants divided into two groups: NSCR group and SCR group. Participants of deep caries lesions (reaching more than two-thirds of dentin on periapical radiographs) Both groups will undergo either NSCR or SCR, followed by Partial Pulpotomy (PP) in cases with pulp exposure. Success rates will be assessed at follow-up visits scheduled 1, 3, and 5 years radiographs will be used to assess for pulp health(vitality). The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality, caries recurrence, and clinical signs of pulpitis. The scale will be applied at follow-up visits. The trial will be conducted in post-graduate dental clinics at Guy's hospital. Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges. The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions, as both NSCR and SCR are commonly used in clinical practice. The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients. In conclusion, this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth, as both methods are commonly used in clinical practice. The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches.

Conditions

Deep Caries; Carious Exposure of Pulp

Outcome Measures

Primary Outcomes (1)

• To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention.

  This study aims to compare between reported success rate (maintained pulp vitality) in cases of deep caries lesion when treated by by Selective caries removal and non-selective caries removal. Pulp sensibility tests will be used to assess the response of the pulp to external stimuli (pulp vitality). The success rate will be calculated as the ratio of cases with maintained pulp vitality to the total treated cases in each group.

  After One year

Secondary Outcomes (2)

• Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment

  At 1, 3 and 5 years after the intervention

• Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy

  after one year of the intervention.

Study Arms (2)

Selective Caries Removal

EXPERIMENTAL

This process will be conducted under an operating microscope to ensure precise removal of carious dentin on cavity walls. Only disorganized carious dentin on the cavity floor will be removed using hand instruments in the control group which is SCR group

Procedure: Selective Caries Removal (No Pulp Exposure); Procedure: Partial Pulpotomy (Pulp Exposed)

Non selective caries removal

EXPERIMENTAL

On the other hand, removal of carious dentin on cavity floor will be completely up to hard sound dentine in NSCR group.

Procedure: Non-Selective Caries Removal (No Pulp exposure); Procedure: Partial Pulpotomy (Pulp Exposed)

Interventions

Selective Caries Removal (No Pulp Exposure) PROCEDURE

Caries excavation technique where clinician leaves carious tissue so close to pulp

Also known as: SCR

Selective Caries Removal

Non-Selective Caries Removal (No Pulp exposure) PROCEDURE

Complete caries removal even in areas so close to pulp

Also known as: NSCR

Non selective caries removal

Partial Pulpotomy (Pulp Exposed) PROCEDURE

In caes of Pulp exposure Amputation of inflamed coronal pulp and capping of remaining vital tissue

Also known as: Miniature Pulpotomy

Non selective caries removal; Selective Caries Removal

Eligibility Criteria

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

You may qualify if:

• Dental patients from routine dental care at ADC (Acute Dental Care) clinics, both undergraduate and postgraduate dental clinics in Guy's Hospital.
• Both male and female individuals aged 18 years and older.
• Capable of providing informed consent.
• Generally, in good overall health from a medical standpoint.
• Possess at least one molar or premolar tooth exhibiting a clinically significant deep carious lesion, with or without carious pulp exposure.
• Displaying signs and symptoms indicative of a normal pulp or reversible pulpitis.
• positive response to the cold test (refrigerated gas).
• Absence of spontaneous pain.
• Absence of periapical lesions, as determined by routine radiographic examination

You may not qualify if:

• Presence of fistulas or swelling.
• Involvement of anterior teeth.
• Evidence of external or internal root resorption.
• Multiple teeth with carious lesions within the same quadrant.
• Pregnancy in women.
• Patients under the age of 18.
• Individuals unable to provide informed consent.
• Patients who have received antibiotics in the preceding month.
• Immunocompromised patients.
• Teeth with tooth surface loss resulting from traumatic parafunctional habits or teeth displaying craze lines.
• Caries located beneath the gingival margin .
• Teeth affected by periodontal issues, characterized by bone loss or severe gingival recession.
• Teeth with pulp exposure where operators cannot achieve hemostasis after applying a cotton pellet soaked with 2.5% sodium hypochlorite (NaOCl) for three cycles, with each cycle consisting of a 2-minute application of NaOCl.
• People with difficulty to understand the clinical trial concept, procedure and details including language barrier.
• participants who are involved in other research at the same period of our study.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Officials

• Francesco Mannoci, Professor

  professor of endodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Mannoci, Professor

CONTACT

02011881573; francesco.mannocci@kcl.ac.uk

Sakha Z Abdelkhader, PhD student

CONTACT

07818723293; sakha.abdelkhader@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two arms parallel randomized clinical trial

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 23, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2030
• Last Updated: April 29, 2024

Record last verified: 2024-04