RCT of Pulp Capping Over Carious Exposure in Adults

Reversible Pulpitis Clinical Trial

Official title:

Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224925
• Other study ID #: UiT-IKO-MTA-001
• Status: Completed
• Phase: N/A
• Start date: October 18, 2010
• Est. completion date: December 10, 2015

Study information

• Verified date: December 2018
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 10, 2015
• Est. primary completion date: December 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion criteria:

• 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)

• 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

Exclusion criteria:

• During the treatment there will be no pulpal exposure

• The bleeding of the exposed pulp cannot be controled in 10 minutes

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Direct pulp capping with Dycal
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 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.

Locations

Country	Name	City	State
Lithuania	Avimeda Dental Clinic	Klaipeda
Norway	Alta Dental Clinic	Alta
Norway	Sandessjoen Dental Clinic	Sandnessjoen
Norway	Tromso University Dental Clinic	Tromso

Sponsors (2)

Lead Sponsor	Collaborator
University of Tromso	Norwegian Public dental health service

Countries where clinical trial is conducted

Lithuania,  Norway, 

References & Publications (25)

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. — View Citation

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. — View Citation

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. — View Citation

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

Bjørndal 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. — View Citation

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. Erratum in: J Am Dent Assoc. 2008 May;139(5):541. — View Citation

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. — View Citation

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. — View Citation

Commentary by Ram Nair Nair PNR, Duncan HF, Pitt Ford TR, Luder HU (2008) Histological, ultrastructural and quantitative investigations on the response of healthy human pulps to experimental capping with Mineral Trioxide Aggregate: a randomized controlled trial. International Endodontic Journal 41, 128-50. Int Endod J. 2009 May;42(5):421. doi: 10.1111/j.1365-2591.2008.01526.x. — View Citation

Eriksen HM, Bergdahl M, Byrkjeflot L-I, Crossner C-G, Tillberg A Evaluation of a dental outreach teaching program. Eur J Dent Educ 2010;(in press)

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. — View Citation

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. — View Citation

Holland R, de Souza V, Nery MJ, Otoboni Filho JA, Bernabé PF, Dezan Júnior 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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2016 Nov 28;11:CD004484. — View Citation

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. Epub 2007 Jun 21. Review. — View Citation

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. — View Citation

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

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. — View Citation

Tronstad L. Reaction of the exposed pulp to Dycal treatment. Oral Surg Oral Med Oral Pathol. 1974 Dec;38(6):945-53. — View Citation

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. — View Citation

Ward J. Vital pulp therapy in cariously exposed permanent teeth and its limitations. Aust Endod J. 2002 Apr;28(1):29-37. Review. — View Citation

Zander HA. Reaction of the pulp to calcium hydroxide. J Dent Res 1939;18:373-9

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	44 month
Secondary	Postoperative Pain 1 Week After Treatment.	Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.	one week