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.
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.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of science and technology
Irbid, 21110
Nessrin Taha, PhD, (62776566110, n.taha@just.edu.jo
+962776566110, nessrin_taha@yahoo.com
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.
- Conditions
- Caries, Reversible Pulpitis
- 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 group | Role | What they receive |
|---|---|---|
| Selective excavation | Active comparator | 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. Receives: Procedure: Selective caries excavation |
| Non selective excavation | Active comparator | Caries 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.
Absence of clinical symptoms
Relief of pain after the procedure
Measured: 48 hours
Secondary outcomes (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.
- First posted3 Dec 2021
- Study start3 Oct 2021
- Primary completion20 Oct 2022 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nessrin Taha, PhD, Principal investigator, Jordan University of Science and Technology
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 32950193Taha 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Versus Nonselective Caries Excavation in Adults: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05144711
- Acronym / sponsor ID
- 528/2021
- Conditions
- Caries, Reversible Pulpitis
- Keywords
- Deep caries, Reversible pulpitis, Selective excavation, Nonselective excavation, Biodentine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cases randomly assigned into the two groups using a block method
| Arm | Type | Receives |
|---|---|---|
| Selective excavation | Active comparator | Procedure: Selective caries excavationCries 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. |
| Non selective excavation | Active comparator | Procedure: Non selective caries excavationCaries will be cleaned form all cavity peripheries and floor. Biodentine will be placed and the toothy will be restored. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Immature roots
- caries exposing the pulp on radiograph
- symptoms of irreversible pulpits
- In ability to control bleeding after pulp exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective caries excavationSelective caries excavation leaving stained but leathery dentine towards the pulp | Procedure or surgery | Selective excavation |
| Non selective caries excavationComplete excavation of caries regardless of the risk of pulp exposure | Procedure or surgery | Non selective excavation |
Primary outcome
Absence of clinical symptoms
Time frame: 48 hours
Relief of pain after the procedure
1 secondary outcome
Pulp vitality
Time frame: 6, 12, 24, 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Results publication: PubMed 32950193Taha 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.
- Derived from this study: PubMed 39442480Taha 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.
- Individual participant dataSharing planned: No. When recruitment is completed and the data is analyzed and submitted for publication. Data may be provided for the benefit of other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nessrin Taha, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
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.