PulpotomyNCT05792748
Comparison of Zinc Oxide Eugenol to Ferric Sulphate Pulpotomy in Primary Teeth
A study testing Pulp hemostasis with a dry cotton pellet, Pulp hemostasis with a wet cotton pellet impregnated with FS and Stainless steel crown in people with Pulpotomy, run by King Abdullah University Hospital at 1 site in Jordan.
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… Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- Pulp hemostasis with a dry cotton pellet, Pulp hemostasis with a wet cotton pellet impregnated with FS and Stainless steel crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteJordan
- Study dates
- 2 Jan 2013to 1 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial Comparing Reinforced Zinc Oxide Eugenol to Ferric Sulphate as a Pulpotomy Agent in Primary Teeth
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.
Read the detailed 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.
- Conditions
- Pulpotomy
- Being tested
- Pulp hemostasis with a dry cotton pellet, Pulp hemostasis with a wet cotton pellet impregnated with FS, Stainless steel crown
- Keywords
- Ferric sulphate, Zinc Oxide Eugenol, Pulpotomy, Primary dentition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulp hemostasis with a dry cotton pelletProcedure or surgery
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 FSProcedure or surgery
Application of a a wet cotton pellet impregnated with FS, then the chamber was filled with ZOE directly over the pulp
Stainless steel crownProcedure or surgery
Stainless steel crown placed as a final restoration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS; Procedure: Stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth which are asymptomatic without clinical signs of disease
including percussion sensitivity, spontaneous pain, mobility, or abscess (Clinical)
Measured: 24 months
Number of teeth with no pathological changes present
including radiolucency, root or bone resorption (Radiographic)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start2 Jan 2013
- Primary completion2 Jan 2014
- Study completion1 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PulpotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Ola B. Al-Batayneh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792748
- Sponsor's protocol ID
- 19/2013
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17119704Casas 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.
PubMed 12723832Casas 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.
PubMed 15080357Chien 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.
PubMed 16894712Fei 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.
PubMed 1843987Hansen 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.
PubMed 5292960Hui-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.
PubMed 23635897Huth 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.
PubMed 16304444Huth 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.
PubMed 21842145Ibricevic 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.
PubMed 11314410Markovic D, Zivojinovic V, Vucetic M. Evaluation of three pulpotomy medicaments in primary teeth. Eur J Paediatr Dent. 2005 Sep;6(3):133-8.
PubMed 16216093Oliveira 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.
PubMed 23549993Papagiannoulis L. Clinical studies on ferric sulphate as a pulpotomy medicament in primary teeth. Eur J Paediatr Dent. 2002 Sep;3(3):126-32.
PubMed 12871001Waterhouse 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.
PubMed 11310245Zurn 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.
PubMed 18402097
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Comparing Reinforced Zinc Oxide Eugenol to Ferric Sulphate as a Pulpotomy Agent in Primary Teeth
- ClinicalTrials.gov ID
- NCT05792748
- Acronym / sponsor ID
- 19/2013
- Conditions
- Pulpotomy
- Keywords
- Ferric sulphate, Zinc Oxide Eugenol, Pulpotomy, Primary dentition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 2 Jan 2013 (actual)
- Primary completion
- 2 Jan 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZOE group | Active comparator | Procedure: Pulp hemostasis with a dry cotton pellet, Procedure: Stainless steel crownPulp 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. |
| FS group | Active comparator | Procedure: Pulp hemostasis with a wet cotton pellet impregnated with FS, Procedure: Stainless steel crownPulp 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulp hemostasis with a dry cotton pelletApplication of a dry cotton pellet, then the chamber was filled with ZOE directly over the pulp | Procedure or surgery | ZOE group |
| Pulp hemostasis with a wet cotton pellet impregnated with FSApplication of a a wet cotton pellet impregnated with FS, then the chamber was filled with ZOE directly over the pulp | Procedure or surgery | FS group |
| Stainless steel crownStainless steel crown placed as a final restoration | Procedure or surgery | FS group, ZOE group |
Primary outcome
Number of teeth which are asymptomatic without clinical signs of disease
Time frame: 24 months
including percussion sensitivity, spontaneous pain, mobility, or abscess (Clinical)
Number of teeth with no pathological changes present
Time frame: 24 months
including radiolucency, root or bone resorption (Radiographic)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 17119704Briso 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.
- Background: PubMed 12723832Casas 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.
- Background: PubMed 15080357Casas 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.
- Background: PubMed 16894712Chien 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.
- Background: PubMed 1843987Fei 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.
- Background: PubMed 5292960Hansen 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.
- Background: PubMed 23635897Hui-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.
- Background: PubMed 16304444Huth 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.
- Background: PubMed 21842145Huth 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.
- Background: PubMed 11314410Ibricevic 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.
- Background: PubMed 16216093Markovic D, Zivojinovic V, Vucetic M. Evaluation of three pulpotomy medicaments in primary teeth. Eur J Paediatr Dent. 2005 Sep;6(3):133-8.
- Background: PubMed 23549993Oliveira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola B. Al-Batayneh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulp hemostasis with a dry cotton pellet, Pulp hemostasis with a wet cotton pellet impregnated with FS and Stainless steel crown in people with Pulpotomy, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of teeth which are asymptomatic without clinical signs of disease (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792748, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.