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

NCT05792748 | Completed

• 1 other identifier: 19/2013
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulpotomy

Keywords

Ferric sulphate; Zinc Oxide Eugenol; Pulpotomy; Primary dentition

Outcome Measures

Primary Outcomes (2)

• Number of teeth which are asymptomatic without clinical signs of disease

  including percussion sensitivity, spontaneous pain, mobility, or abscess (Clinical)

  24 months

• Number of teeth with no pathological changes present

  including radiolucency, root or bone resorption (Radiographic)

  24 months

Study Arms (2)

ZOE group

ACTIVE COMPARATOR

Pulp hemostasis achieved by a dry cotton pellet applied on the pulp, then the chamber was filled with reinforced zinc oxide eugenol (ZOE) directly over the pulp.

Procedure: Pulp hemostasis with a dry cotton pellet; Procedure: Stainless steel crown

FS group

ACTIVE COMPARATOR

Pulp hemostasis achieved by a wet cotton pellet impregnated with ferric sulphate (FS) applied on the pulp, then the chamber was filled with (ZOE) directly over the pulp.

Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS; Procedure: Stainless steel crown

Interventions

Pulp hemostasis with a dry cotton pellet PROCEDURE

Application of a dry cotton pellet, then the chamber was filled with ZOE directly over the pulp

ZOE group

Pulp hemostasis with a wet cotton pellet impregnated with FS PROCEDURE

Application of a a wet cotton pellet impregnated with FS, then the chamber was filled with ZOE directly over the pulp

FS group

Stainless steel crown PROCEDURE

Stainless steel crown placed as a final restoration

FS group; ZOE group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related 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.

  PMID: 17119704 BACKGROUND

• 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.

  PMID: 12723832 BACKGROUND

• 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.

  PMID: 15080357 BACKGROUND

• 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.

  PMID: 16894712 BACKGROUND

• 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.

  PMID: 1843987 BACKGROUND

• 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.

  PMID: 5292960 BACKGROUND

• 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.

  PMID: 23635897 BACKGROUND

• 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.

  PMID: 16304444 BACKGROUND

• 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.

  PMID: 21842145 BACKGROUND

• 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.

  PMID: 11314410 BACKGROUND

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

  PMID: 16216093 BACKGROUND

• 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.

  PMID: 23549993 BACKGROUND

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

  PMID: 12871001 BACKGROUND

• 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.

  PMID: 11310245 BACKGROUND

• 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.

  PMID: 18402097 BACKGROUND

Study Officials

• Ola B. Al-Batayneh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 31, 2023
• Study Start: January 2, 2013
• Primary Completion: January 2, 2014
• Study Completion: April 1, 2014
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)