Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Norwegian Public dental health service | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct pulp capping with Dycal | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 44 month |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain 1 Week After Treatment. | Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded. | one week |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rita Kundzina, DDS, PhD | University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avimeda Dental Clinic | KlaipÄ—da | 91210 | Lithuania | |||
| Alta Dental Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Zander HA. Reaction of the pulp to calcium hydroxide. J Dent Res 1939;18:373-9 | ||
| Background | 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 | ||
| 7030965 | Background | Baume LJ, Holz J. Long term clinical assessment of direct pulp capping. Int Dent J. 1981 Dec;31(4):251-60. | |
| 4216870 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ten subjects were excluded due to a lack of pulpal exposure after the complete removal of caries before assignment to groups
Four Dental Clinics
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dycal - Calcium Hydroxide Material | Pulp capping with Dycal Direct pulp capping over carious exposure: Dycal: covered with Fuji IX. After one week,part of the temporary filling was left under the permanent filling |
| FG001 | WMTA - White Mineral Trioxide Aggregate | Pulp capping with Mineral Trioxide Aggregate Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX. After one week, the entire temporary filling was removed the cavity was permanently restored with a composite resin material used at the study clinic |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We did not recorded patients sex and gender
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dycal - Calcium Hydroxide Material | Pulp capping with Dycal Direct pulp capping over carious exposure: Dycal: covered with Fuji IX. After one week,part of the temporary filling was left under the permanent filling |
| BG001 | WMTA - White Mineral Trioxide Aggregate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Three patients were lost from follow-up in Dycal group, two patients in WMTA group. Intention to treat principle (ITT) was applied; the analysis comprised all allocated cases | Posted | Mean | 95% Confidence Interval | Survival days | 44 month | Tooth | Tooth |
|
36 month
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capping Over Carious Exposure With Dycal | Direct pulp capping over carious exposure: Dycal: covered with Fuji IX |
Not provided
Not provided
The power calculation was not performed separately for the secondary outcome, thus the analysis was underpowered and it may hide the existing differences in the occurrence of pain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate professor Rita Kundzina | UiT The Arctic University of Norway (Tromsø university) | +4777649118 | rita.kundzina@uit.no |
Not provided
| ID | Term |
|---|---|
| C025702 | Dycal |
Not provided
Not provided
Not provided
Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
Not provided
Not provided
Patient -blinded
|
| Direct pulp capping | Procedure | 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. |
|
|
| Alta |
| 9510 |
| Norway |
| Sandessjoen Dental Clinic | Sandnessjøen | 8800 | Norway |
| Tromso University Dental Clinic | Tromsø | 9037 | Norway |
| Background |
| Tronstad 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. |
| 3858095 | Background | Horsted 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. |
| 11199794 | Background | Barthel 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. |
| 12360679 | Background | Ward 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. |
| 9760878 | Background | Stanley HR. Criteria for standardizing and increasing credibility of direct pulp capping studies. Am J Dent. 1998 Jan;11 Spec No:S17-34. |
| 8151252 | Background | Torabinejad 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. |
| 8908918 | Background | Ford 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. |
| 10726538 | Background | Holland 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. |
| 11985676 | Background | Tziafas 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. |
| 16603042 | Background | Asgary 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. |
| 15022999 | Background | Salako 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. |
| 17315797 | Background | Farsi 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. |
| 12657149 | Background | Aeinehchi M, Eslami B, Ghanbariha M, Saffar AS. Mineral trioxide aggregate (MTA) and calcium hydroxide as pulp-capping agents in human teeth: a preliminary report. Int Endod J. 2003 Mar;36(3):225-31. doi: 10.1046/j.1365-2591.2003.00652.x. |
| 17256303 | Background | Caicedo R, Abbott PV, Alongi DJ, Alarcon MY. Clinical, radiographic and histological analysis of the effects of mineral trioxide aggregate used in direct pulp capping and pulpotomies of primary teeth. Aust Dent J. 2006 Dec;51(4):297-305. doi: 10.1111/j.1834-7819.2006.tb00447.x. |
| 16683667 | Background | Chacko V, Kurikose S. Human pulpal response to mineral trioxide aggregate (MTA): a histologic study. J Clin Pediatr Dent. 2006 Spring;30(3):203-9. doi: 10.17796/jcpd.30.3.38h13g5p84651652. |
| 16764130 | Background | Iwamoto CE, Adachi E, Pameijer CH, Barnes D, Romberg EE, Jefferies S. Clinical and histological evaluation of white ProRoot MTA in direct pulp capping. Am J Dent. 2006 Apr;19(2):85-90. |
| 17956562 | Background | Nair PN, Duncan HF, Pitt Ford TR, Luder HU. Histological, ultrastructural and quantitative investigations on the response of healthy human pulps to experimental capping with mineral trioxide aggregate: a randomized controlled trial. Int Endod J. 2008 Feb;41(2):128-50. doi: 10.1111/j.1365-2591.2007.01329.x. Epub 2007 Oct 23. |
| 18310735 | Background | Bogen G, Kim JS, Bakland LK. Direct pulp capping with mineral trioxide aggregate: an observational study. J Am Dent Assoc. 2008 Mar;139(3):305-15; quiz 305-15. doi: 10.14219/jada.archive.2008.0160. |
| 17586038 | Background | Roberts HW, Toth JM, Berzins DW, Charlton DG. Mineral trioxide aggregate material use in endodontic treatment: a review of the literature. Dent Mater. 2008 Feb;24(2):149-64. doi: 10.1016/j.dental.2007.04.007. Epub 2007 Jun 21. |
| 17443547 | Background | Miyashita H, Worthington HV, Qualtrough A, Plasschaert A. Pulp management for caries in adults: maintaining pulp vitality. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004484. doi: 10.1002/14651858.CD004484.pub2. |
| 21226799 | Background | Eriksen HM, Bergdahl M, Byrkjeflot LI, Crossner CG, Widstrom E, Tillberg A. Evaluation of a dental outreach teaching programme. Eur J Dent Educ. 2011 Feb;15(1):3-7. doi: 10.1111/j.1600-0579.2010.00636.x. |
| 22078824 | Background | Bjorndal L. Stepwise excavation may enhance pulp preservation in permanent teeth affected by dental caries. J Evid Based Dent Pract. 2011 Dec;11(4):175-7. doi: 10.1016/j.jebdp.2011.09.005. |
| 27891629 | Derived | Kundzina R, Stangvaltaite L, Eriksen HM, Kerosuo E. Capping carious exposures in adults: a randomized controlled trial investigating mineral trioxide aggregate versus calcium hydroxide. Int Endod J. 2017 Oct;50(10):924-932. doi: 10.1111/iej.12719. Epub 2016 Nov 28. |
Pulp capping with Mineral Trioxide Aggregate Direct pulp capping: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Gender was not recorded | Number | participants |
|
| Tooth number Upper first molar | Number | participants |
|
| Upper second molar | Number | participants |
|
| Lower first molar | Number | participants |
|
| Lower second molar | Number | participants |
|
| Cavity type Occlusial | Number | participants |
|
| Mesial-occlusial | Number | participants |
|
| Distal-occlusial | Number | participants |
|
| Mesial-oclusial-distal | Number | participants |
|
| Caries depth 2/3 into the dentine | Number | participants |
|
| Caries depth >2/3 into the dentine | Number | participants |
|
| Into the pulp | Number | participants |
|
| Preoperative pain | Number | participants |
|
Pulp capping with Mineral Trioxide Aggregate Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX |
|
|
|
| Secondary | Postoperative Pain 1 Week After Treatment. | Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded. | Postoperative pain 1 week after treatment | Posted | Number | participants | one week |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Capping Over Carious Exposure With WMTA | Direct pulp capping: WMTA capping over exposed pulp, wet pellet, FujiIX | 0 | 33 | 0 | 33 | 0 | 33 |
Not provided
Not provided
Not provided