Comparison of Zinc Oxide Eugenol to Ferric Sulphate Pulpotomy in Primary Teeth

Pulpotomy Clinical Trial

Official title:

A Clinical Trial Comparing Reinforced Zinc Oxide Eugenol to Ferric Sulphate as a Pulpotomy Agent in Primary Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792748
• Other study ID #: 19/2013
• Status: Completed
• Phase: N/A
• Start date: January 2, 2013
• Est. completion date: April 1, 2014

Study information

• Verified date: March 2023
• Source: King Abdullah University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this prospective randomized, single blinded; split-mouth clinical trial the aim was to evaluate clinical and radiographic effects of placement of reinforced zinc oxide eugenol (ZOE) base directly over the amputated pulp stumps in pulpotomized primary molars, and to compare this technique to ferric sulphate (FS) in pulpotomized primary teeth. Included were 65 children using a split-mouth design, (130 teeth). All teeth were then restored with prefabricated stainless steel crowns (SSC). Patients were recalled for clinical and radiographical evaluation after 3, 6, 12 and 24 months. Two experienced and calibrated pediatric dentists who were not involved in the investigation blindly assessed the radiographs.

Description:

Purpose: The purpose of this study was to evaluate the clinical and radiographic effects of placement of reinforced zinc oxide eugenol (ZOE) base directly over the amputated pulp stumps in pulpotomized primary molars, and to compare the effects of this technique to ferric sulphate (FS) agent in pulpotomized primary teeth. Methods: A sample of 65 children with bilateral deep carious mandibular primary molars who attended the pediatric dental clinics, at Jordan University of Science and Technology (JUST) were selected for this prospective randomized, single blinded; split-mouth clinical trial. The teeth were randomly divided into 2 treatment groups: in the ZOE group (n=65 teeth) hemostasis was achieved by a dry cotton pellet, then the chamber was filled with zinc oxide eugenol (ZOE) directly over the pulp on one side. In the FS group (n=65 teeth) hemostasis was achieved by a wet cotton pellet, ferric sulphate (FS) was applied on the pulp, then the chamber was filled with (ZOE) on the contralateral side. All teeth were restored with prefabricated stainless steel crowns (SSC). Patients were recalled for evaluation clinically after 1month, then clinically and radiographically after 3, 6, 12 and 24 months. Two experienced and calibrated pediatric dentists who were not involved in the investigation blindly assessed the radiographs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 1, 2014
• Est. primary completion date: January 2, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• Healthy children
• Child has cooperative behaviour in the dental chair
• No history of spontaneous pain
• Deep caries in the tooth
• Carious exposure of a vital pulp
• A restorable tooth after completion of the pulp treatment
• Healthy periapical tissue on pre-operative periapical radiograph

Exclusion Criteria:

• Presence of tenderness to percussion and/or mobility
• Pathologic radiographic signs on pre-operative periapical radiograph including external or internal root resorption, calcification in the canal, periodontal membrane widening, periapical pathology, and furcation radiolucency.

Related Conditions & MeSH terms

• Pulpotomy

Intervention

Procedure:
• Pulp hemostasis with a dry cotton pellet
Application of a dry cotton pellet, then the chamber was filled with ZOE directly over the pulp
• Pulp hemostasis with a wet cotton pellet impregnated with FS
Application of a a wet cotton pellet impregnated with FS, then the chamber was filled with ZOE directly over the pulp
• Stainless steel crown
Stainless steel crown placed as a final restoration

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah University Hospital	Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (15)

Briso AL, Rahal V, Mestrener SR, Dezan Junior E. Biological response of pulps submitted to different capping materials. Braz Oral Res. 2006 Jul-Sep;20(3):219-25. doi: 10.1590/s1806-83242006000300007. — View Citation

Casas MJ, Kenny DJ, Johnston DH, Judd PL. Long-term outcomes of primary molar ferric sulfate pulpotomy and root canal therapy. Pediatr Dent. 2004 Jan-Feb;26(1):44-8. — View Citation

Casas MJ, Layug MA, Kenny DJ, Johnston DH, Judd PL. Two-year outcomes of primary molar ferric sulfate pulpotomy and root canal therapy. Pediatr Dent. 2003 Mar-Apr;25(2):97-102. — View Citation

Chien MM, Setzer S, Cleaton-Jones P. How does zinc oxide-eugenol compare to ferric sulphate as a pulpotomy material? SADJ. 2001 Mar;56(3):130-5. — View Citation

Fei AL, Udin RD, Johnson R. A clinical study of ferric sulfate as a pulpotomy agent in primary teeth. Pediatr Dent. 1991 Nov-Dec;13(6):327-32. — View Citation

Hansen HP, Ravn JJ, Ulrich D. Vital pulpotomy in primary molars. A clinical and histologic investigation of the effect of zinc oxide-eugenol cement and Ledermix. Scand J Dent Res. 1971;79(1):13-25. No abstract available. — View Citation

Hui-Derksen EK, Chen CF, Majewski R, Tootla RG, Boynton JR. Retrospective record review: reinforced zinc oxide-eugenol pulpotomy: a retrospective study. Pediatr Dent. 2013 Jan-Feb;35(1):43-6. — View Citation

Huth KC, Hajek-Al-Khatar N, Wolf P, Ilie N, Hickel R, Paschos E. Long-term effectiveness of four pulpotomy techniques: 3-year randomised controlled trial. Clin Oral Investig. 2012 Aug;16(4):1243-50. doi: 10.1007/s00784-011-0602-3. Epub 2011 Aug 13. — View Citation

Huth KC, Paschos E, Hajek-Al-Khatar N, Hollweck R, Crispin A, Hickel R, Folwaczny M. Effectiveness of 4 pulpotomy techniques--randomized controlled trial. J Dent Res. 2005 Dec;84(12):1144-8. doi: 10.1177/154405910508401210. — View Citation

Ibricevic H, al-Jame Q. Ferric sulfate as pulpotomy agent in primary teeth: twenty month clinical follow-up. J Clin Pediatr Dent. 2000 Summer;24(4):269-72. doi: 10.17796/jcpd.24.4.d7u6405nw1132705. — View Citation

Markovic D, Zivojinovic V, Vucetic M. Evaluation of three pulpotomy medicaments in primary teeth. Eur J Paediatr Dent. 2005 Sep;6(3):133-8. — View Citation

Oliveira TM, Moretti AB, Sakai VT, Lourenco Neto N, Santos CF, Machado MA, Abdo RC. Clinical, radiographic and histologic analysis of the effects of pulp capping materials used in pulpotomies of human primary teeth. Eur Arch Paediatr Dent. 2013 Apr;14(2):65-71. doi: 10.1007/s40368-013-0015-x. Epub 2013 Apr 3. — View Citation

Papagiannoulis L. Clinical studies on ferric sulphate as a pulpotomy medicament in primary teeth. Eur J Paediatr Dent. 2002 Sep;3(3):126-32. — View Citation

Waterhouse PJ, Nunn JH, Whitworth JM, Soames JV. Primary molar pulp therapy--histological evaluation of failure. Int J Paediatr Dent. 2000 Dec;10(4):313-21. doi: 10.1046/j.1365-263x.2000.00211.x. — View Citation

Zurn D, Seale NS. Light-cured calcium hydroxide vs formocresol in human primary molar pulpotomies: a randomized controlled trial. Pediatr Dent. 2008 Jan-Feb;30(1):34-41. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of teeth which are asymptomatic without clinical signs of disease	including percussion sensitivity, spontaneous pain, mobility, or abscess (Clinical)	24 months
Primary	Number of teeth with no pathological changes present	including radiolucency, root or bone resorption (Radiographic)	24 months