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CariesNCT05144711

Management of Deep Carious Lesions in Adults

A study testing Selective caries excavation and Non selective caries excavation in people with Caries and Reversible Pulpitis, run by Jordan University of Science and Technology at 1 site in Jordan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Caries, Reversible Pulpitis
What is being tested?
Selective caries excavation and Non selective caries excavation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteJordan
Study dates
3 Oct 2021to Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • Immature roots
  • caries exposing the pulp on radiograph
  • symptoms of irreversible pulpits
  • In ability to control bleeding after pulp exposure

Trial locations and contacts

1 site in 1 country.

Nessrin Taha, PhD contact

962776566110

n.taha@just.edu.jo

Jordan1 site, 1 recruiting
  • Jordan University of science and technology

    Irbid, 21110

    Nessrin Taha, PhD, (62776566110, n.taha@just.edu.jo

    +962776566110, nessrin_taha@yahoo.com

    Recruiting

Other trials in Jordan

About this study

Official title: Selective Versus Nonselective Caries Excavation in Adults: Randomized Clinical Trial

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

Read the detailed description

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.

Being tested
Selective caries excavation, Non selective caries excavation
Keywords
Deep caries, Reversible pulpitis, Selective excavation, Nonselective excavation, Biodentine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selective caries excavationProcedure or surgery

    Selective caries excavation leaving stained but leathery dentine towards the pulp

  • Non selective caries excavationProcedure or surgery

    Complete excavation of caries regardless of the risk of pulp exposure

Study groups in NCT05144711
Study groupRoleWhat they receive
Selective excavationActive comparatorCries 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.
Receives: Procedure: Selective caries excavation
Non selective excavationActive comparatorCaries will be cleaned form all cavity peripheries and floor. Biodentine will be placed and the toothy will be restored.
Receives: Procedure: Non selective caries excavation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absence of clinical symptoms

    Relief of pain after the procedure

    Measured: 48 hours

Secondary outcomes (1)
  1. Pulp vitality

    Absence of clinical and radiographic signs of pulp pathosis, in addition to normal response to cold testing

    Measured: 6, 12, 24, 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start3 Oct 2021
  3. Primary completion20 Oct 2022 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cases randomly assigned into the two groups using a block method
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05144711
Sponsor's protocol ID
528/2021
Status last verified
Sep 2022
First submitted
22 Nov 2021
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: When recruitment is completed and the data is analyzed and submitted for publication. Data may be provided for the benefit of other researchers.

Publications

  • Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025.

    PubMed 32950193
  • Taha NA, Ali MM, Abidin IZ, Khader YS. Pulp survival and postoperative treatment needs following selective vs. total caries removal in mature permanent teeth with reversible pulpitis: A randomized clinical trial. J Dent. 2024 Dec;151:105408. doi: 10.1016/j.jdent.2024.105408. Epub 2024 Oct 22.

    PubMed 39442480

Questions about this trial

What is this clinical trial studying?

A study testing Selective caries excavation and Non selective caries excavation in people with Caries and Reversible Pulpitis, run by Jordan University of Science and Technology at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nessrin Taha, PhD (962776566110, n.taha@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of clinical symptoms (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05144711, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.

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