Reversible PulpitisPhase 4NCT02201641
Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial
A Phase 4 study testing Cone Beam computed tomography (Morita Accuitomo), Periapical radiographs and calcium silicate cement (Biodentine™) in people with Reversible Pulpitis, run by King's College London at 1 site in United Kingdom.
Trial summary
This study aims to investigate the tooth nerve response to a recently introduced therapeutic filling material (calcium silicate cement) called Biodentine and to assess the quality of the overlying filling compared to another material (glass ionomer cement) called Fuji IX used more commonly. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- Cone Beam computed tomography (Morita Accuitomo), Periapical radiographs and calcium silicate cement (Biodentine™)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Jul 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients either male or female over the age of 16 (who can consent for themselves) in good general health
- A minimum of one carious lesion (occlusal, proximal, or MOD)
- Positive pulp response to electric pulp test and thermal stimulation.
Who cannot join
- Patients with clinical symptoms of irreversible pulpitis who need root canal treatment
- The presence of fistulas or swelling
- Anterior teeth with aesthetic concerns
- External or internal root resorption
- Multiple teeth with carious lesions in the same quadrant,
- Mobile teeth or tenderness to percussion.
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- Pregnant women, in view of requirements for radiographs.
- Patients younger than 16.
- Patients unable to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Dental Institute at Guy's Hospital
London, London, SE1 9RT
About this study
This study aims to investigate the tooth nerve response to a recently introduced therapeutic filling material (calcium silicate cement) called Biodentine and to assess the quality of the overlying filling compared to another material (glass ionomer cement) called Fuji IX used more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays compared to conventional periapical x-rays in detecting lesions around these teeth.
Read the detailed description
Tooth decay is one of the most widespread diseases in the world. Very often, a patient comes to the dental clinic when experiencing pain which commonly means the decay is deep and is very close to or has penetrated the nerve of the tooth. When the decay is very close to the pulp or nerve of the tooth, a procedure called pulp capping is done in an attempt to save the tooth and to prevent root canal treatment. A material has been introduced to the market for this purpose, called Biodentine. This study aims to investigate the nerve response to this material and to assess the quality of the overlying filling compared to another material (glass ionomer cement) used more commonly. Also, X-rays are a routine procedure used to assess how close the decay is to the nerve and to see if there are abnormalities around the tooth. However conventional X-rays may not be accurate. A new technique called Cone Beam Computed Tomography (CBCT) has been developed which shows a 3-D image of the tooth and may be more accurate. We aim to compare the images gained from conventional X-rays and CBCT to help improve diagnosis and care planning for patients.
- Conditions
- Reversible Pulpitis
- Being tested
- Cone Beam computed tomography (Morita Accuitomo), Periapical radiographs, calcium silicate cement (Biodentine™), glass ionomer cement ( Fuji IX™)
- Keywords
- Indirect pulp capping, reversible pulpitis, periapical radiolucency, periapical radiographs, cone beam computed tomography, calcium silicate cements, glass ionomer cements, caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam computed tomography (Morita Accuitomo)Radiation
CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
Periapical radiographsRadiation
Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
calcium silicate cement (Biodentine™)Device
calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
glass ionomer cement ( Fuji IX™)Device
glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp.
| Study group | Role | What they receive |
|---|---|---|
| calcium silicate cement (Biodentine™) | Experimental | calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps. Receives: Device: calcium silicate cement (Biodentine™) |
| Cone Beam computed tomography (CBCT) | Experimental | CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions. Receives: Radiation: Cone Beam computed tomography (Morita Accuitomo) |
| Periapical radiographs | Active comparator | Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions. Receives: Radiation: Periapical radiographs |
| Glass ionomer cement ( Fuji IX™) | Active comparator | Glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps. Receives: Device: glass ionomer cement ( Fuji IX™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination.
The vitality of the restored tooth (whether the nerve of the tooth is alive or dead) is determined clinically by a positive response to cold test, absence of spontaneous pain, negative sensitivity to percussion, absence of sinus/fistula/swelling and abnormal mobility, and absence/reduction of periapical radiolucencies as determined by PA radiographs.
Measured: up to 2 years
Secondary outcomes (2)
The integrity of the composite restoration overlying the test or control material is either acceptable or not.
As assessed clinically by USPHS criteria and Hickel's criteria for the assessment of dental restorations.
Measured: up to 2 years
The CBCT scans of the teeth restored with the test or control material are either more effective or are comparable to conventional radiographs in detecting the presence of early peri-radicular lesions associated with the restored teeth.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJul 2012
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (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 Reversible PulpitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy F Watson, BDS,MSc,PhD, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201641
- Sponsor's protocol ID
- 11-LO-1893
- Status last verified
- Feb 2017
- First submitted
- 23 Jul 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hashem D, Mannocci F, Patel S, Manoharan A, Watson TF, Banerjee A. Evaluation of the efficacy of calcium silicate vs. glass ionomer cement indirect pulp capping and restoration assessment criteria: a randomised controlled clinical trial-2-year results. Clin Oral Investig. 2019 Apr;23(4):1931-1939. doi: 10.1007/s00784-018-2638-0. Epub 2018 Sep 19.
PubMed 30232625Hashem D, Mannocci F, Patel S, Manoharan A, Brown JE, Watson TF, Banerjee A. Clinical and radiographic assessment of the efficacy of calcium silicate indirect pulp capping: a randomized controlled clinical trial. J Dent Res. 2015 Apr;94(4):562-8. doi: 10.1177/0022034515571415. Epub 2015 Feb 20.
PubMed 25710953
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02201641
- Acronym / sponsor ID
- 11-LO-1893
- Conditions
- Reversible Pulpitis
- Keywords
- Indirect pulp capping, reversible pulpitis, periapical radiolucency, periapical radiographs, cone beam computed tomography, calcium silicate cements, glass ionomer cements, caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 28 Jul 2014 (estimated)
- 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.
This study aims to investigate the tooth nerve response to a recently introduced therapeutic filling material (calcium silicate cement) called Biodentine and to assess the quality of the overlying filling compared to another material (glass ionomer cement) called Fuji IX used more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays compared to conventional periapical x-rays in detecting lesions around these teeth.
Detailed description
Tooth decay is one of the most widespread diseases in the world. Very often, a patient comes to the dental clinic when experiencing pain which commonly means the decay is deep and is very close to or has penetrated the nerve of the tooth. When the decay is very close to the pulp or nerve of the tooth, a procedure called pulp capping is done in an attempt to save the tooth and to prevent root canal treatment. A material has been introduced to the market for this purpose, called Biodentine. This study aims to investigate the nerve response to this material and to assess the quality of the overlying filling compared to another material (glass ionomer cement) used more commonly. Also, X-rays are a routine procedure used to assess how close the decay is to the nerve and to see if there are abnormalities around the tooth. However conventional X-rays may not be accurate. A new technique called Cone Beam Computed Tomography (CBCT) has been developed which shows a 3-D image of the tooth and may be more accurate. We aim to compare the images gained from conventional X-rays and CBCT to help improve diagnosis and care planning for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| calcium silicate cement (Biodentine™) | Experimental | Device: calcium silicate cement (Biodentine™)calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps. |
| Cone Beam computed tomography (CBCT) | Experimental | Radiation: Cone Beam computed tomography (Morita Accuitomo)CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions. |
| Periapical radiographs | Active comparator | Radiation: Periapical radiographsPeriapical radiographs are taken as a control to detect the presence of early peri-radicular lesions. |
| Glass ionomer cement ( Fuji IX™) | Active comparator | Device: glass ionomer cement ( Fuji IX™)Glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients either male or female over the age of 16 (who can consent for themselves) in good general health
- A minimum of one carious lesion (occlusal, proximal, or MOD)
- Positive pulp response to electric pulp test and thermal stimulation.
Key exclusion criteria (9 listed)
- Patients with clinical symptoms of irreversible pulpitis who need root canal treatment
- The presence of fistulas or swelling
- Anterior teeth with aesthetic concerns
- External or internal root resorption
- Multiple teeth with carious lesions in the same quadrant,
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 |
|---|---|---|
| Cone Beam computed tomography (Morita Accuitomo)CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions. | Radiation | Cone Beam computed tomography (CBCT) |
| Periapical radiographsPeriapical radiographs are taken as a control to detect the presence of early peri-radicular lesions. | Radiation | Periapical radiographs |
| calcium silicate cement (Biodentine™)calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps. | Device | calcium silicate cement (Biodentine™) |
| glass ionomer cement ( Fuji IX™)glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp. | Device | Glass ionomer cement ( Fuji IX™) |
Primary outcome
The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination.
Time frame: up to 2 years
The vitality of the restored tooth (whether the nerve of the tooth is alive or dead) is determined clinically by a positive response to cold test, absence of spontaneous pain, negative sensitivity to percussion, absence of sinus/fistula/swelling and abnormal mobility, and absence/reduction of periapical radiolucencies as determined by PA radiographs.
2 secondary outcomes
The integrity of the composite restoration overlying the test or control material is either acceptable or not.
Time frame: up to 2 years
The CBCT scans of the teeth restored with the test or control material are either more effective or are comparable to conventional radiographs in detecting the presence of early peri-radicular lesions associated with the restored teeth.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 30232625Hashem D, Mannocci F, Patel S, Manoharan A, Watson TF, Banerjee A. Evaluation of the efficacy of calcium silicate vs. glass ionomer cement indirect pulp capping and restoration assessment criteria: a randomised controlled clinical trial-2-year results. Clin Oral Investig. 2019 Apr;23(4):1931-1939. doi: 10.1007/s00784-018-2638-0. Epub 2018 Sep 19.
- Derived from this study: PubMed 25710953Hashem D, Mannocci F, Patel S, Manoharan A, Brown JE, Watson TF, Banerjee A. Clinical and radiographic assessment of the efficacy of calcium silicate indirect pulp capping: a randomized controlled clinical trial. J Dent Res. 2015 Apr;94(4):562-8. doi: 10.1177/0022034515571415. Epub 2015 Feb 20.
- Individual participant dataSharing planned: No
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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.
Timothy F Watson, BDS,MSc,PhD study chair
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cone Beam computed tomography (Morita Accuitomo), Periapical radiographs and calcium silicate cement (Biodentine™) in people with Reversible Pulpitis, run by King's College London at 1 site in United Kingdom.
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 3 inclusion and 9 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 3 Mar 2017. 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 United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination. (time frame: up to 2 years). 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 NCT02201641, 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 3 Mar 2017.