Reversible PulpitisNCT03071588
Assessment of a New Protocol for Indirect Pulp Capping Procedures
A study testing Mechanical rotary burs and Carisolv gel in people with Reversible Pulpitis, run by King's College London.
Trial summary
The aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- Mechanical rotary burs and Carisolv gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of reversible pulpitis with positive response to cold pulp test.
Who cannot join
- Clinical diagnosis of irreversible pulpitis, Pregnant women, mobile teeth and teeth with tenderness to percussion.
About this study
The aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. It was postulated that there is no difference between both protocols in terms clinical, radiographical and microbial outcome measure after one year of follow up in painful teeth.
Read the detailed description
Indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth / pulp while relieving pain, This study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries. One group of patients will be treated with a standard clinical procedure which involve mechanical rotary burs with no magnification for caries removal, the other group will be treated with a more conservative clinical procedure using CarisolvTM gel with the aid of an operating microscope for caries removal. The study also involves taking of samples from the tooth decay for microbiological / biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition. The study also compare the radiographical findings of 3D cone beam computed tomography (CBCT) scans with that of normal Xrays in detecting the presence of early bone changes associated with the roots of these teeth.
The study carried out at King's College London/ Dental Institute at Guy's Hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans. Volunteers given written information about the process and given time to consider participation. Once any questions have been answered, fully informed written consent obtained if they are interested in taking part. At least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and Xray dental assessment. The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturer's instructions and the definitive filling will be placed, follow up will at 12 months. Radiographic assessment including cone beam computed tomography (CBCT) will be done at baseline and 12 months. It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure.
- Conditions
- Reversible Pulpitis
- Being tested
- Mechanical rotary burs, Carisolv gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical rotary bursDevice
A rotary drill made of steel or diamond impregnated materials attached to a steel shank, available in varying degree of sharpness, lengths and sizes used conventionally in preparation of teeth to receive a dental restoration.
Carisolv gelDevice
A chemical gel made of a combination of amino acids and sodium hypochlorite used with hand instruments to soften and remove the decay to prepare the tooth to receive a dental restoration.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | the conventional protocol in indirect pulp capping include the use of mechanical rotary burs for caries removal in teeth with reversible pulpitis. Receives: Device: Mechanical rotary burs |
| Conservative | Experimental | the conservative protocol of indirect pulp capping include the use of Carisolv gel for caries removal in teeth with reversible pulpitis. Receives: Device: Carisolv gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
cold pulp test (signalling the nerve of the pulp of the tooth by cold application)
Binary variable outcome measure whether the nerve is positively or negatively responsive to the cold test.
Measured: One year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startJul 2014
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients, each group received the investigated intervention at baseline and being followed up in parallel for one year.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Mannocci, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071588
- Sponsor's protocol ID
- 14/LO/0880
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali AH, Thani FB, Foschi F, Banerjee A, Mannocci F. Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results. J Clin Med. 2020 Aug 25;9(9):2738. doi: 10.3390/jcm9092738.
PubMed 32854206Ali AH, Koller G, Foschi F, Andiappan M, Bruce KD, Banerjee A, Mannocci F. Self-Limiting versus Conventional Caries Removal: A Randomized Clinical Trial. J Dent Res. 2018 Oct;97(11):1207-1213. doi: 10.1177/0022034518769255. Epub 2018 May 8.
PubMed 29738286
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Protocol for Indirect Pulp Capping Procedures
- ClinicalTrials.gov ID
- NCT03071588
- Acronym / sponsor ID
- 14/LO/0880
- Conditions
- Reversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 7 Mar 2017 (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.
The aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. It was postulated that there is no difference between both protocols in terms clinical, radiographical and microbial outcome measure after one year of follow up in painful teeth.
Detailed description
Indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth / pulp while relieving pain, This study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries. One group of patients will be treated with a standard clinical procedure which involve mechanical rotary burs with no magnification for caries removal, the other group will be treated with a more conservative clinical procedure using CarisolvTM gel with the aid of an operating microscope for caries removal. The study also involves taking of samples from the tooth decay for microbiological / biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition. The study also compare the radiographical findings of 3D cone beam computed tomography (CBCT) scans with that of normal Xrays in detecting the presence of early bone changes associated with the roots of these teeth.
The study carried out at King's College London/ Dental Institute at Guy's Hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans. Volunteers given written information about the process and given time to consider participation. Once any questions have been answered, fully informed written consent obtained if they are interested in taking part. At least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and Xray dental assessment. The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturer's instructions and the definitive filling will be placed, follow up will at 12 months. Radiographic assessment including cone beam computed tomography (CBCT) will be done at baseline and 12 months. It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of patients, each group received the investigated intervention at baseline and being followed up in parallel for one year.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Mechanical rotary bursthe conventional protocol in indirect pulp capping include the use of mechanical rotary burs for caries removal in teeth with reversible pulpitis. |
| Conservative | Experimental | Device: Carisolv gelthe conservative protocol of indirect pulp capping include the use of Carisolv gel for caries removal in teeth with reversible pulpitis. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of reversible pulpitis with positive response to cold pulp test.
Key exclusion criteria (1 listed)
- Clinical diagnosis of irreversible pulpitis, Pregnant women, mobile teeth and teeth with tenderness to percussion.
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 |
|---|---|---|
| Mechanical rotary bursA rotary drill made of steel or diamond impregnated materials attached to a steel shank, available in varying degree of sharpness, lengths and sizes used conventionally in preparation of teeth to receive a dental restoration. | Device | Control |
| Carisolv gelA chemical gel made of a combination of amino acids and sodium hypochlorite used with hand instruments to soften and remove the decay to prepare the tooth to receive a dental restoration. | Device | Conservative |
Primary outcome
cold pulp test (signalling the nerve of the pulp of the tooth by cold application)
Time frame: One year follow up
Binary variable outcome measure whether the nerve is positively or negatively responsive to the cold test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 32854206Ali AH, Thani FB, Foschi F, Banerjee A, Mannocci F. Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results. J Clin Med. 2020 Aug 25;9(9):2738. doi: 10.3390/jcm9092738.
- Derived from this study: PubMed 29738286Ali AH, Koller G, Foschi F, Andiappan M, Bruce KD, Banerjee A, Mannocci F. Self-Limiting versus Conventional Caries Removal: A Randomized Clinical Trial. J Dent Res. 2018 Oct;97(11):1207-1213. doi: 10.1177/0022034518769255. Epub 2018 May 8.
- Individual participant dataSharing planned: No
Related trials for Reversible Pulpitis
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Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
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Pulp Inflammatory Markers and Outcome of Pulpotomy
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Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .
Reversible Pulpitis, Deep Caries
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.
Francesco Mannocci principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical rotary burs and Carisolv gel in people with Reversible Pulpitis, run by King's College London.
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 1 inclusion and 1 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
cold pulp test (signalling the nerve of the pulp of the tooth by cold application) (time frame: One year follow up). 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 NCT03071588, 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 7 Mar 2018.