Tooth DiscolorationNCT04346849
Tooth Discoloration Induced by Pulpotomy Materials
A study testing Pulpotomy in people with Tooth Discoloration, run by Jordan University of Science and Technology at 2 sites in Jordan.
Trial summary
Vital pulp therapy including pulpotomy is commonly used for managing teeth with carious pulp exposure instead of performing root canal therapy. The gold standard materials used in this procedure are the calcium silicate based materials, however recent case reports have shown tooth discoloration caused by these… Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesJordan
- Study dates
- 2 Sep 2017to 2 May 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Vital tooth with carious pulp exposure to be treated by full pulpotomy
- Fully erupted upper or lower molar tooth with fully formed apex
- Tooth should have intact buccal wall (no caries or restoration)
- Tooth should be restorable by direct composite restoration
Who cannot join
- Partially erupted tooth
- Tooth has caries on the buccal surface
- Tooth has restoration on buccal surface
- Tooth has preoperative coronal staining compared to adjacent teeth
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Dental teaching centre Faculty Of Dentistry
Irbid, 21110
Jordan University of science and technology
Irbid, 22110
About this study
Official title: Tooth Discoloration Induced by Different Calcium Silicate Based Materials: in Vivo Study
Vital pulp therapy including pulpotomy is commonly used for managing teeth with carious pulp exposure instead of performing root canal therapy. The gold standard materials used in this procedure are the calcium silicate based materials, however recent case reports have shown tooth discoloration caused by these materials especially MTA which is of concern to the patients. The aim of this study is to compare tooth color changes and discoloration induced by 3 calcium silicate based materials used in pulpotomy over 6 months, 12 months and yearly up to 5 years.
Read the detailed description
Pulpotomy procedure involves removal of the coronal portion of the dental pulp followed by placement of a compatible material and subsequent coronal restoration of the tooth. Mineral trioxide aggregate is the gold standard material used in pulpotomy; however it has been implicated in tooth discoloration due to it radioopacifier. newer calcium silicate based materials including Biodentine and bioceramic have different opacifier and claimed not to cause tooth discoloration in laboratory studies.
In this clinical study tooth color measurement of teeth treated by pulpotomy using these 3 materials will be taken using vita easy shade device immediately after placement of the materials, 6 months and 12 months after the treatment then yearly up to 5 years. The discoloration potential of these 3 materials will be compared. Factors that may influence tooth discoloration will be also measured and analyzed including buccal wall thickness and time of bleeding control after pulpotomy.
- Conditions
- Tooth Discoloration
- Being tested
- Pulpotomy
- Keywords
- Pulpotomy, MTA, Biodentine, Bioceramic, discoloration
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration
| Study group | Role | What they receive |
|---|---|---|
| MTA pulpotomy | Experimental | Teeth receiving pulpotomy using MTA Receives: Procedure: Pulpotomy |
| Biodentine pulpotomy | Experimental | Teeth receiving pulpotomy using Biodentine Receives: Procedure: Pulpotomy |
| Bioceramic pulpotomy | Experimental | Teeth receiving pulpotomy using Bioceramic Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth color change
Darkening in tooth color shade after placement of the calcium silicate based material
Measured: Immediate, 6 months, 1 year and yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start2 Sep 2017
- Primary completion2 May 2018
- Study completion2 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies 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
- Three groups will receive the same treatment procedure but randomly assigned to one of three different materials, tooth color changes will be measured at certain time points and will be compared between the 3 groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nessrin Taha, Jordan University of Science and Technology
- Investigators
- Nessrin Taha, DCD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346849
- Sponsor's protocol ID
- 5/2018
- Status last verified
- May 2024
- First submitted
- 12 Apr 2020
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared in the publication of the 1 year results of the study. If furthers details or data required the study chair can be contacted by email
Publications
Taha NA, Hamdan AM, Al-Hiyasat AS. Coronal discoloration induced by calcium silicate-based cements used in full pulpotomy in mature permanent molars: a randomized clinical trial. Clin Oral Investig. 2023 Apr;27(4):1723-1730. doi: 10.1007/s00784-022-04799-x. Epub 2022 Nov 29.
PubMed 36445467
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Discoloration Induced by Different Calcium Silicate Based Materials: in Vivo Study
- ClinicalTrials.gov ID
- NCT04346849
- Acronym / sponsor ID
- 5/2018
- Conditions
- Tooth Discoloration
- Keywords
- Pulpotomy, MTA, Biodentine, Bioceramic, discoloration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Sep 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2025 (estimated)
- First posted
- 15 Apr 2020 (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.
Vital pulp therapy including pulpotomy is commonly used for managing teeth with carious pulp exposure instead of performing root canal therapy. The gold standard materials used in this procedure are the calcium silicate based materials, however recent case reports have shown tooth discoloration caused by these materials especially MTA which is of concern to the patients. The aim of this study is to compare tooth color changes and discoloration induced by 3 calcium silicate based materials used in pulpotomy over 6 months, 12 months and yearly up to 5 years.
Detailed description
Pulpotomy procedure involves removal of the coronal portion of the dental pulp followed by placement of a compatible material and subsequent coronal restoration of the tooth. Mineral trioxide aggregate is the gold standard material used in pulpotomy; however it has been implicated in tooth discoloration due to it radioopacifier. newer calcium silicate based materials including Biodentine and bioceramic have different opacifier and claimed not to cause tooth discoloration in laboratory studies.
In this clinical study tooth color measurement of teeth treated by pulpotomy using these 3 materials will be taken using vita easy shade device immediately after placement of the materials, 6 months and 12 months after the treatment then yearly up to 5 years. The discoloration potential of these 3 materials will be compared. Factors that may influence tooth discoloration will be also measured and analyzed including buccal wall thickness and time of bleeding control after pulpotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups will receive the same treatment procedure but randomly assigned to one of three different materials, tooth color changes will be measured at certain time points and will be compared between the 3 groups.
| Arm | Type | Receives |
|---|---|---|
| MTA pulpotomy | Experimental | Procedure: PulpotomyTeeth receiving pulpotomy using MTA |
| Biodentine pulpotomy | Experimental | Procedure: PulpotomyTeeth receiving pulpotomy using Biodentine |
| Bioceramic pulpotomy | Experimental | Procedure: PulpotomyTeeth receiving pulpotomy using Bioceramic |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Vital tooth with carious pulp exposure to be treated by full pulpotomy
- Fully erupted upper or lower molar tooth with fully formed apex
- Tooth should have intact buccal wall (no caries or restoration)
- Tooth should be restorable by direct composite restoration
Key exclusion criteria (4 listed)
- Partially erupted tooth
- Tooth has caries on the buccal surface
- Tooth has restoration on buccal surface
- Tooth has preoperative coronal staining compared to adjacent teeth
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 |
|---|---|---|
| PulpotomyCutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration | Procedure or surgery | Bioceramic pulpotomy, Biodentine pulpotomy, MTA pulpotomy |
Primary outcome
Tooth color change
Time frame: Immediate, 6 months, 1 year and yearly up to 5 years
Darkening in tooth color shade after placement of the calcium silicate based material
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Derived from this study: PubMed 36445467Taha NA, Hamdan AM, Al-Hiyasat AS. Coronal discoloration induced by calcium silicate-based cements used in full pulpotomy in mature permanent molars: a randomized clinical trial. Clin Oral Investig. 2023 Apr;27(4):1723-1730. doi: 10.1007/s00784-022-04799-x. Epub 2022 Nov 29.
- Individual participant dataSharing planned: No. The data will be shared in the publication of the 1 year results of the study. If furthers details or data required the study chair can be contacted by email
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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, DCD study chair
Jordan University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy in people with Tooth Discoloration, run by Jordan University of Science and Technology at 2 sites 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 4 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 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Tooth color change (time frame: Immediate, 6 months, 1 year and yearly up to 5 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 NCT04346849, which also lists 1 linked publication.
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 2 May 2024.