Management of Deep Carious Lesions in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-03

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dental caries is one of the most prevalent non-communicable disease. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete nonselective excavation suggests there may be benefit for selective removal in sustaining tooth vitality while histological studies reveal that the remaining dentine is actually infected and may cause loss of vitality in long term.

The aim of this study is to randomly compare selective to non-elective excavation methods in carious mature permanent teeth with symptoms of reversible pulpitis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Selective Versus Non-selective Caries Excavation in MIH Affected Teeth.

NCT07142629

Molar Incisor Hypomineralisation Dental Caries

ENROLLING_BY_INVITATION NA

Partial Pulpotomy vs Selective Removing in Deep Caries

NCT07120009

Deep Dentin Caries in Mature Permanent Teeth

NOT_YET_RECRUITING NA

Selective or Stepwise Removal of Deep Caries

NCT02232828

Dental Caries

UNKNOWN NA

Outcome of Selective & Nonselective Caries Removal in Permanent Teeth

NCT06378814

Deep Caries Carious Exposure of Pulp

NOT_YET_RECRUITING NA

Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

NCT04375215

Caries

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of this study is to randomly compare selective to nonselective excavation methods in carious mature permanent teeth with symptoms of reversible pulpitis over 4 years.

Cases will be collected from the initial treatment unit and the undergraduate clinics over a 8 months' period, the minimum sample size required is 120 teeth in 120 patients for an assumed difference of 20% in the success rate and accounting for 20% wear rate in the follow up, randomization will be performed using tabular randomization. Intensity of pulp symptoms will be recorded, patient's description of sensitivity to hot/cold/sweet lasting up to 15-20s and settling spontaneously are considered mild, while increased pain for more than several minutes and needing pain killers are considered severe.

Inclusion criteria:

* The patient age (16-60) years old
* Non -contributory medical history
* Deep caries extending\>= 2/3 of dentine but not exposing the pulp on the radiograph
* The tooth should give positive response to cold testing
* Clinical diagnosis of reversible pulpitis
* The tooth is restorable, probing pocket depth and mobility are within normal limits
* No signs of pulpal necrosis including sinus tract or swelling
* No radiographic evidence of periapical changes indicative of apical periodontitis

Preoperative pulpal and periapical diagnosis will be established after clinical examination including soft tissue palpation, percussion, and cold testing (, and digital periapical and bitewing radiographs will be taken using film holders and a paralleling technique.

Baseline characteristics of the patient (age, gender) and the treated tooth (number, position, caries extension) will be recorded. Each tooth will be randomly allocated for the choice of treatment with selective or nonselective caries excavation according to a random sequence number generator.

Clinical procedure: The clinical procedure will be performed by one calibrated postgraduate student under supervision. The tooth will be anesthetized with , rubber dam will be applied and the tooth crown will be disinfected with 5% NaOCl before caries excavation; The cases will be divided randomly into:

Group 1: One-stage selective carious-tissue removal to soft or firm dentine, using carbon-steel rose- head burs (ash instruments) in a slow speed headpiece, the excavation end point is the detection of leathery dentine using a sharp dental explorer and excavator.

Group 2: Non-selective carious-tissue removal. The tooth will be isolated with rubber dam and disinfected with NaOCl. Complete caries excavation will be removed from the entire cavity, inspection under the microscope will be done to identify pulp exposure. If no pulp exposure is evident Biodentine will be placed and the cavity will be restored with composite. If pulp exposure occurred, and it is bleeding normally and uniformly red with no zones of degeneration or necrosis then direct pulp capping will be the choice of the treatment. The bleeding will be controlled via gentle pressure with a cotton pellet soaked with 2.5% NaOCl over the pulpal wound for 2 minutes and repeated if required up to 5 times.

In both groups, 2mm of Biodentine will be used and vitrebond will be placed as a liner on top, this will be followed by etching with 37% orthophosphoric acid, rinsing with water, and then bonding with adhesive followed by the placement of resin composite. Flowable composites will be used in deep cavities if needed. Clinical and radiographic success will be evaluated at 6 months, 1 year, 2 years and 4 years postoperatively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caries Reversible Pulpitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cases randomly assigned into the two groups using a block method

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

An informed consent will be obtained from the participant but he will not be informed whether selective or non selective excavation was done for him.

the outcome assessor will be blinded to the procedure, and if required masking of the crowns of teeth on radiographs will be done before evaluation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Selective excavation

Cries will be removed from the peripheries of the cavity, while only soft caries will be removed from the plural side leaving stained leathery dentine that can not be removed by hand instruments. Biodentine will be placed and the cavity will be restored.

Group Type ACTIVE_COMPARATOR

Selective caries excavation

Intervention Type PROCEDURE

Selective caries excavation leaving stained but leathery dentine towards the pulp

Non selective excavation

Caries will be cleaned form all cavity peripheries and floor. Biodentine will be placed and the toothy will be restored.

Group Type ACTIVE_COMPARATOR

Non selective caries excavation

Intervention Type PROCEDURE

Complete excavation of caries regardless of the risk of pulp exposure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Selective caries excavation

Selective caries excavation leaving stained but leathery dentine towards the pulp

Intervention Type PROCEDURE

Non selective caries excavation

Complete excavation of caries regardless of the risk of pulp exposure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patient age (16-60) years old
* Non -contributory medical history
* Deep caries extending\>= 2/3 of dentine but not exposing the pulp on the radiograph
* The tooth should give positive response to cold testing
* Clinical diagnosis of reversible pulpitis
* The tooth is restorable, probing pocket depth and mobility are within normal limits
* No signs of pulpal necrosis including sinus tract or swelling
* No radiographic evidence of periapical changes indicative of apical periodontitis