RCT of Pulp Capping Over Carious Exposure in Adults

NCT01224925 | Completed Results

• 1 other identifier: UiT-IKO-MTA-001
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 4

Brief 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 material in mature molar teeth with a carious pulpal exposure.

Conditions

Carious Exposure; Human Permanent First and Second Molars; Mature Teeth; Proximal Caries; Healthy Pulp; Reversible Pulpitis

Keywords

carious exposure; pulp capping; MTA; Dycal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative Pain 1 Week After Treatment.

  one week

Study Arms (2)

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)

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)

Procedure: Direct pulp capping

Interventions

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

Also known as: (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany

Capping over carious exposure with Dycal

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.

Also known as: WMTA - White Mineral Trioxide Aggregate

Capping over carious exposure with WMTA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-55 years
• st 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)
• 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

You may not qualify if:

• During the treatment there will be no pulpal exposure
• The bleeding of the exposed pulp cannot be controled in 10 minutes

Sponsors & Collaborators

• University of Tromso: lead
• Norwegian Public dental health service: collaborator

Study Sites (4)

Avimeda Dental Clinic

Klaipėda, 91210, Lithuania

Location

Alta Dental Clinic

Alta, 9510, Norway

Location

Sandessjoen Dental Clinic

Sandnessjøen, 8800, Norway

Location

Tromso University Dental Clinic

Tromsø, 9037, Norway

Location

Related Publications (26)

• 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

  BACKGROUND

• Baume LJ, Holz J. Long term clinical assessment of direct pulp capping. Int Dent J. 1981 Dec;31(4):251-60.

  PMID: 7030965 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.

  PMID: 4216870 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.

  PMID: 3858095 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.

  PMID: 11199794 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.

  PMID: 12360679 BACKGROUND

• Stanley HR. Criteria for standardizing and increasing credibility of direct pulp capping studies. Am J Dent. 1998 Jan;11 Spec No:S17-34.

  PMID: 9760878 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.

  PMID: 8151252 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.

  PMID: 8908918 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.

  PMID: 10726538 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.

  PMID: 11985676 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.

  PMID: 16603042 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.

  PMID: 15022999 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.

  PMID: 17315797 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.

  PMID: 12657149 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.

  PMID: 17256303 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.

  PMID: 16683667 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.

  PMID: 16764130 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.

  PMID: 17956562 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.

  PMID: 18310735 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.

  PMID: 17586038 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.

  PMID: 17443547 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.

  PMID: 21226799 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.

  PMID: 22078824 BACKGROUND

• 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.

  PMID: 27891629 DERIVED

MeSH Terms

Interventions

Dycal

Limitations and Caveats

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.

Results Point of Contact

• Title: Associate professor Rita Kundzina
• Organization: UiT The Arctic University of Norway (Tromsø university)

rita.kundzina@uit.no

+4777649118

Study Officials

• Rita Kundzina, DDS, PhD

  University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient -blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS,PhD (Associate professor (endodontics)

Model Details: Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 20, 2010
• Study Start: October 18, 2010
• Primary Completion: December 10, 2015
• Study Completion: December 10, 2015
• Last Updated: March 18, 2019
• Results First Posted: March 18, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); NO (3)