Carious ExposureNCT01224925
RCT of Pulp Capping Over Carious Exposure in Adults
A study testing Direct pulp capping with Dycal and Direct pulp capping in people with Carious Exposure and Human Permanent First and Second Molars, run by University of Tromso at 4 sites in 2 countries.
Trial summary
This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner (Dycal®) as a direct pulp capping… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Carious Exposure, Human Permanent First and Second Molars, Mature Teeth
- What is being tested?
- Direct pulp capping with Dycal and Direct pulp capping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 18 Oct 2010to 10 Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years
- 1st and 2nd permanent molars
- Proximal caries to inner 1/3 of dentin (bite-wing)
- Apex closed, no periapical changes (apical radiograph)
- No periodontal pockets deeper than 4mm
- Medical history non-contributory (incl.pregnancy)
Show all 10Show fewer
- No medication (no antibiotics during last month)
- No signs or symptoms more severe than reversible pulpitis
- Positive response to electrical pulp test(EPT) or cold test
- Written consent Inclusion requires compliance with all the criteria listed
Who cannot join
- During the treatment there will be no pulpal exposure
- The bleeding of the exposed pulp cannot be controled in 10 minutes
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Norway3 sites
Alta Dental Clinic
Alta, 9510
Sandessjoen Dental Clinic
Sandnessjøen, 8800
Tromso University Dental Clinic
Tromsø, 9037
About this study
Official title: Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal
This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with a carious pulpal exposure.
Read the detailed description
Calcium hydroxide (CH) is considered the standard material for pulp capping with good results in cases with pulpal exposure as a result of dental trauma both in animal and clinical studies. However, in carious exposures, follow-up studies of direct pulp capping performed with CH based materials have shown increasing failure rates and the outcome has been considered uncertain. Direct capping of carious exposures still remains a controversial treatment for mature teeth.
A new material, mineral trioxide aggregate (MTA) was introduced for root end filling material almost two decades ago. It is also suggested for pulp capping. MTA cement has showed good sealing ability and bio-compatibility in animal studies. Results from studies in humans corroborate the results from animal studies.
Although the overall results of pulp capping in human studies using MTA are very positive, well designed and controlled clinical studies, especially involving carious exposures on adult teeth are lacking.At the time the present study was launched, there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth, thus undermining the generalizability of the results to adult patients with carious exposures.
- Conditions
- Carious Exposure, Human Permanent First and Second Molars, Mature Teeth, Proximal Caries, Healthy Pulp, Reversible Pulpitis
- Being tested
- Direct pulp capping with Dycal, Direct pulp capping
- Keywords
- carious exposure, pulp capping, MTA, Dycal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct pulp capping with DycalProcedure or surgery
Also called (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany
Capping over carious exposure with Dycal. Dycal: covered with Fuji IX. After one week, part of the temporary filling was left under the permanent filling
Direct pulp cappingProcedure or surgery
Also called WMTA - White Mineral Trioxide Aggregate
WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic.
| Study group | Role | What they receive |
|---|---|---|
| Capping over carious exposure with Dycal | Active comparator | Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany) Receives: Procedure: Direct pulp capping with Dycal |
| Capping over carious exposure with WMTA | Experimental | Total caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA) Receives: Procedure: Direct pulp capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of Capped Pulps
Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study.
Measured: 44 month
Secondary outcomes (1)
Postoperative Pain 1 Week After Treatment.
Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study start18 Oct 2010
- Primary completion10 Dec 2015
- Study completion10 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Carious ExposureStudies 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
- Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Public dental health service
- Responsible party
- Principal investigator, Rita Kundzina, University of Tromso
- Investigators
- Rita Kundzina, DDS, PhD, Principal investigator, University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224925
- Sponsor's protocol ID
- UiT-IKO-MTA-001
- Status last verified
- Dec 2018
- First submitted
- 18 Oct 2010
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zander HA. Reaction of the pulp to calcium hydroxide. J Dent Res 1939;18:373-9
Hørsted-Bindslev P, Bergenholtz G. Vital pulp therapies. In: Bergenholtz G,Hørsted-Bindslev P, Reit C. Textbook of endodontology. Blackwell Munksgaard,Oxford;2003:66-91
Baume LJ, Holz J. Long term clinical assessment of direct pulp capping. Int Dent J. 1981 Dec;31(4):251-60.
PubMed 7030965Tronstad L. Reaction of the exposed pulp to Dycal treatment. Oral Surg Oral Med Oral Pathol. 1974 Dec;38(6):945-53. doi: 10.1016/0030-4220(74)90348-x. No abstract available.
PubMed 4216870Horsted P, Sandergaard B, Thylstrup A, El Attar K, Fejerskov O. A retrospective study of direct pulp capping with calcium hydroxide compounds. Endod Dent Traumatol. 1985 Feb;1(1):29-34. doi: 10.1111/j.1600-9657.1985.tb00555.x. No abstract available.
PubMed 3858095Barthel CR, Rosenkranz B, Leuenberg A, Roulet JF. Pulp capping of carious exposures: treatment outcome after 5 and 10 years: a retrospective study. J Endod. 2000 Sep;26(9):525-8. doi: 10.1097/00004770-200009000-00010.
PubMed 11199794Ward J. Vital pulp therapy in cariously exposed permanent teeth and its limitations. Aust Endod J. 2002 Apr;28(1):29-37. doi: 10.1111/j.1747-4477.2002.tb00364.x.
PubMed 12360679Stanley HR. Criteria for standardizing and increasing credibility of direct pulp capping studies. Am J Dent. 1998 Jan;11 Spec No:S17-34.
PubMed 9760878Torabinejad M, Watson TF, Pitt Ford TR. Sealing ability of a mineral trioxide aggregate when used as a root end filling material. J Endod. 1993 Dec;19(12):591-5. doi: 10.1016/S0099-2399(06)80271-2.
PubMed 8151252Ford TR, Torabinejad M, Abedi HR, Bakland LK, Kariyawasam SP. Using mineral trioxide aggregate as a pulp-capping material. J Am Dent Assoc. 1996 Oct;127(10):1491-4. doi: 10.14219/jada.archive.1996.0058.
PubMed 8908918Holland R, de Souza V, Nery MJ, Otoboni Filho JA, Bernabe PF, Dezan Junior E. Reaction of dogs' teeth to root canal filling with mineral trioxide aggregate or a glass ionomer sealer. J Endod. 1999 Nov;25(11):728-30. doi: 10.1016/s0099-2399(99)80118-6.
PubMed 10726538Tziafas D, Pantelidou O, Alvanou A, Belibasakis G, Papadimitriou S. The dentinogenic effect of mineral trioxide aggregate (MTA) in short-term capping experiments. Int Endod J. 2002 Mar;35(3):245-54. doi: 10.1046/j.1365-2591.2002.00471.x.
PubMed 11985676Asgary S, Parirokh M, Eghbal MJ, Ghoddusi J, Eskandarizadeh A. SEM evaluation of neodentinal bridging after direct pulp protection with mineral trioxide aggregate. Aust Endod J. 2006 Apr;32(1):26-30. doi: 10.1111/j.1747-4477.2006.00004.x.
PubMed 16603042Salako N, Joseph B, Ritwik P, Salonen J, John P, Junaid TA. Comparison of bioactive glass, mineral trioxide aggregate, ferric sulfate, and formocresol as pulpotomy agents in rat molar. Dent Traumatol. 2003 Dec;19(6):314-20. doi: 10.1046/j.1600-9657.2003.00204.x.
PubMed 15022999Farsi N, Alamoudi N, Balto K, Al Mushayt A. Clinical assessment of mineral trioxide aggregate (MTA) as direct pulp capping in young permanent teeth. J Clin Pediatr Dent. 2006 Winter;31(2):72-6. doi: 10.17796/jcpd.31.2.n462281458372u64.
PubMed 17315797
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal
- ClinicalTrials.gov ID
- NCT01224925
- Acronym / sponsor ID
- UiT-IKO-MTA-001
- Conditions
- Carious Exposure, Human Permanent First and Second Molars, Mature Teeth, Proximal Caries, Healthy Pulp, Reversible Pulpitis
- Keywords
- carious exposure, pulp capping, MTA, Dycal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- Norwegian Public dental health service
- Study start
- 18 Oct 2010 (actual)
- Primary completion
- 10 Dec 2015 (actual)
- Study completion
- 10 Dec 2015 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Posted 18 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with a carious pulpal exposure.
Detailed description
Calcium hydroxide (CH) is considered the standard material for pulp capping with good results in cases with pulpal exposure as a result of dental trauma both in animal and clinical studies. However, in carious exposures, follow-up studies of direct pulp capping performed with CH based materials have shown increasing failure rates and the outcome has been considered uncertain. Direct capping of carious exposures still remains a controversial treatment for mature teeth.
A new material, mineral trioxide aggregate (MTA) was introduced for root end filling material almost two decades ago. It is also suggested for pulp capping. MTA cement has showed good sealing ability and bio-compatibility in animal studies. Results from studies in humans corroborate the results from animal studies.
Although the overall results of pulp capping in human studies using MTA are very positive, well designed and controlled clinical studies, especially involving carious exposures on adult teeth are lacking.At the time the present study was launched, there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth, thus undermining the generalizability of the results to adult patients with carious exposures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Capping over carious exposure with Dycal | Active comparator | Procedure: Direct pulp capping with DycalTotal caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany) |
| Capping over carious exposure with WMTA | Experimental | Procedure: Direct pulp cappingTotal caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18-55 years
- 1st and 2nd permanent molars
- Proximal caries to inner 1/3 of dentin (bite-wing)
- Apex closed, no periapical changes (apical radiograph)
- No periodontal pockets deeper than 4mm
Key exclusion criteria (2 listed)
- During the treatment there will be no pulpal exposure
- The bleeding of the exposed pulp cannot be controled in 10 minutes
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 |
|---|---|---|
| Direct pulp capping with DycalAlso: (Dycal®, Dentsply DeTrey GmbH, Konstanz, GermanyCapping over carious exposure with Dycal. Dycal: covered with Fuji IX. After one week, part of the temporary filling was left under the permanent filling | Procedure or surgery | Capping over carious exposure with Dycal |
| Direct pulp cappingAlso: WMTA - White Mineral Trioxide AggregateWMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic. | Procedure or surgery | Capping over carious exposure with WMTA |
Primary outcome
Survival of Capped Pulps
Time frame: 44 month
Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study.
1 secondary outcome
Postoperative Pain 1 Week After Treatment.
Time frame: one week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundZander HA. Reaction of the pulp to calcium hydroxide. J Dent Res 1939;18:373-9
- BackgroundHørsted-Bindslev P, Bergenholtz G. Vital pulp therapies. In: Bergenholtz G,Hørsted-Bindslev P, Reit C. Textbook of endodontology. Blackwell Munksgaard,Oxford;2003:66-91
- Background: PubMed 7030965Baume LJ, Holz J. Long term clinical assessment of direct pulp capping. Int Dent J. 1981 Dec;31(4):251-60.
- Background: PubMed 4216870Tronstad L. Reaction of the exposed pulp to Dycal treatment. Oral Surg Oral Med Oral Pathol. 1974 Dec;38(6):945-53. doi: 10.1016/0030-4220(74)90348-x. No abstract available.
- Background: PubMed 3858095Horsted P, Sandergaard B, Thylstrup A, El Attar K, Fejerskov O. A retrospective study of direct pulp capping with calcium hydroxide compounds. Endod Dent Traumatol. 1985 Feb;1(1):29-34. doi: 10.1111/j.1600-9657.1985.tb00555.x. No abstract available.
- Background: PubMed 11199794Barthel CR, Rosenkranz B, Leuenberg A, Roulet JF. Pulp capping of carious exposures: treatment outcome after 5 and 10 years: a retrospective study. J Endod. 2000 Sep;26(9):525-8. doi: 10.1097/00004770-200009000-00010.
- Background: PubMed 12360679Ward J. Vital pulp therapy in cariously exposed permanent teeth and its limitations. Aust Endod J. 2002 Apr;28(1):29-37. doi: 10.1111/j.1747-4477.2002.tb00364.x.
- Background: PubMed 9760878Stanley HR. Criteria for standardizing and increasing credibility of direct pulp capping studies. Am J Dent. 1998 Jan;11 Spec No:S17-34.
- Background: PubMed 8151252Torabinejad M, Watson TF, Pitt Ford TR. Sealing ability of a mineral trioxide aggregate when used as a root end filling material. J Endod. 1993 Dec;19(12):591-5. doi: 10.1016/S0099-2399(06)80271-2.
- Background: PubMed 8908918Ford TR, Torabinejad M, Abedi HR, Bakland LK, Kariyawasam SP. Using mineral trioxide aggregate as a pulp-capping material. J Am Dent Assoc. 1996 Oct;127(10):1491-4. doi: 10.14219/jada.archive.1996.0058.
- Background: PubMed 10726538Holland R, de Souza V, Nery MJ, Otoboni Filho JA, Bernabe PF, Dezan Junior E. Reaction of dogs' teeth to root canal filling with mineral trioxide aggregate or a glass ionomer sealer. J Endod. 1999 Nov;25(11):728-30. doi: 10.1016/s0099-2399(99)80118-6.
- Background: PubMed 11985676Tziafas D, Pantelidou O, Alvanou A, Belibasakis G, Papadimitriou S. The dentinogenic effect of mineral trioxide aggregate (MTA) in short-term capping experiments. Int Endod J. 2002 Mar;35(3):245-54. doi: 10.1046/j.1365-2591.2002.00471.x.
- 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.
Rita Kundzina, DDS, PhD principal investigator
University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct pulp capping with Dycal and Direct pulp capping in people with Carious Exposure and Human Permanent First and Second Molars, run by University of Tromso at 4 sites in 2 countries.
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 10 inclusion and 2 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: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway, Lithuania. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival of Capped Pulps (time frame: 44 month). 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 NCT01224925, which also lists 26 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 18 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.