FS with ZOE Materials for Toothache

Overseen By Jayakumar Jayaraman, BDS MDS PhD

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Virginia Commonwealth University

Disqualifiers: Pulp degeneration, Excessive bleeding, Pathologic mobility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

19 Participants Needed

Trial Summary

What is the purpose of this trial?

Internal resorption in the most common cause of failure in FS pulpotomies in primary molars. This has been attributed to the release of free eugenol from the zinc and eugenol mixture of the base material over the pulp tissue. Zinc oxide-eugenol (ZOE) paste is the most common base material placed over the infected pulp tissues during pulpotomies of primary molars, however the evidence suggests that the eugenol component has been associated with the failure of the vital pulp treatment in primary molars. Cavit (3M, US) is another base material that contains Zinc-oxide, zinc sulphate, and calcium salts without eugenol. The effectiveness of non-eugenol based Zinc oxide as a base material over ferric sulphate treated pulp has not been explored. The hypothesis is that the non-eugenol based ZOE could be used as an alternate to eugenol based ZOE and thereby avoid the radiological failures. Therefore, this randomized controlled clinical split-mouth trial aimed to evaluate and compare the effect of eugenol and non-eugenol based ZOE on the success of primary tooth pulpotomies where FS is used as a medicament.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that FS with ZOE Materials for Toothache is an effective treatment?

The available research shows that FS with ZOE materials is effective for treating toothaches, especially in primary molars. One study compared FS to root canal therapy and found it to be a viable option for long-term outcomes. Another study showed that FS had similar success rates to mineral trioxide aggregate, another treatment option. Additionally, FS was compared to sodium hypochlorite and found to be effective when used with ZOE as a base material. Overall, FS is shown to be a successful treatment for managing toothaches in primary teeth. ^{1 2 3 4 5}

What safety data exists for FS with ZOE materials for toothache treatment?

The safety data for FS (Ferric Sulphate) and ZOE (Zinc Oxide-Eugenol) materials in dental treatments primarily comes from studies on their use in pulpotomies, particularly in primary molars. Research indicates that FS is used as a pulpotomy medicament and has been compared to other agents like formocresol and mineral trioxide aggregate. Studies have evaluated the clinical and radiographic success, as well as the pulpal tissue reaction, showing varying degrees of inflammation and healing. While FS is considered an alternative to formocresol, it did not show improved pulpal response in some studies. Overall, FS and ZOE have been used in dental practice, but the safety data suggests mixed results regarding inflammation and healing outcomes. ^{2 3 4 5 6}

Is FS with ZOE Materials a promising treatment for toothache?

Yes, FS (Ferric Sulphate) is a promising treatment for toothache, especially in primary molars. Studies show it works well compared to other treatments, helping to manage tooth decay effectively. ^{1 4 5 7 8}

Research Team

Jayakumar Jayaraman, BDS MDS PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for children aged 3 to 7 with toothache due to reversible pulpitis in primary molars, which are not overly resorbed and can be restored with a crown. Kids mustn't have spontaneous pain, signs of advanced pulp issues, excessive bleeding, swelling or fistulae, nor any root resorption seen on x-rays.

Inclusion Criteria

Restorable with stainless steel crown

Only teeth having no more than one third of their roots undergoing physiologic resorption were included

I have a toothache caused by a cavity that can be treated.

Exclusion Criteria

Inter radicular or periapical radiolucency.

Clinical or radiographic evidence of pulp degeneration

I experience sudden and nighttime pain.

Treatment Details

Interventions

• FS
• Non-eugenol based ZOE
• Pulpotomy
• ZOE

Trial Overview The study compares two base materials used in pulpotomies: one eugenol based (traditional ZOE) and one non-eugenol based (Cavit), both combined with Ferric Sulfate. It's designed to see if the non-eugenol option reduces failures like internal resorption.

Participant Groups

Group I: non-eugenol based ZOE and Ferric Sulfate Experimental Treatment 1 Intervention

non-eugenol based ZOE and Ferric Sulfate in primary molar pulpotomy procedures.

Group II: eugenol based zinc oxide and Ferric Sulfate Experimental Treatment 1 Intervention

eugenol based zinc oxide and Ferric Sulfate in primary molars pulpotomies procedures.

FS is already approved in United States, European Union for the following indications:

Approved in United States as Ferric Sulphate for:

• Primary tooth pulpotomies

Approved in European Union as Ferric Sulphate for:

• Primary tooth pulpotomies

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

In a study involving 291 deciduous molars treated in 130 children, root canal therapy (RCT) showed a significantly higher 3-year survival probability (92%) compared to ferric sulfate pulpotomy (FS) (62%).

No significant differences in radiographic outcomes were found between the two treatments, but RCT was associated with better long-term survival, indicating it may be the more effective option for treating carious lesions in vital pulps of primary molars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of primary molar ferric sulfate pulpotomy and root canal therapy. Casas, MJ., Kenny, DJ., Johnston, DH., et al.[2016]

In a study of 179 patients undergoing pulpotomy in primary molars, ferric sulfate (FS) showed greater therapeutic success compared to formocresol (FC), especially in a two-appointment treatment (90.6% success) versus one-appointment (77.1%).

When restoring teeth, glass-ionomer cements (GIC) were associated with a lower risk of complications compared to composite materials, suggesting GIC is a safer option when stainless steel crowns are not used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric Sulfate and Formocresol pulpotomies in paediatric dental practice. A prospective-retrospective study. Olczak-Kowalczyk, D., Samul, M., Góra, J., et al.[2019]

In a study involving 93 children aged 5 to 10, mineral trioxide aggregate (MTA) showed higher clinical success rates (94.7%) compared to ferric sulphate (FS) (84.7%) for vital pulpotomy in primary molars, indicating MTA may be a more effective option.

Both MTA and FS demonstrated similar safety profiles, with no significant differences in clinical and radiographic outcomes, suggesting that either material can be effectively used for pulpotomies in primary teeth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic success rates of mineral trioxide aggregate and ferric sulphate pulpotomies performed by dental students. Odabaş, ME., Alaçam, A., Sillelioğlu, H., et al.[2019]

In a study involving 29 healthy children and 80 primary molars, both 15.5% ferric sulfate and 1.25% sodium hypochlorite were effective for hemostasis in pulpotomies, with high clinical success rates of 95% to 100% across different treatment groups after 12 months.

Zinc oxide-eugenol and calcium hydroxide were both effective as base materials post-hemostasis, showing no significant difference in clinical or radiographic success rates, indicating flexibility in treatment options for primary tooth pulpotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary molar pulpotomies with different hemorrhage control agents and base materials: A randomized clinical trial. Atasever, G., Keceli, TI., Uysal, S., et al.[2022]

A systematic review of 1371 studies found only two high-quality studies on the efficacy of ferric sulphate (FS) as a pulpotomy medicament in primary molars, indicating a lack of robust evidence for its effectiveness.

While four randomized clinical trials reported high success rates with FS, the majority of studies (14 out of 20) showed lower success rates compared to other pulpotomy materials, suggesting that more rigorous research is needed to validate FS's use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ferric sulphate as a pulpotomy medicament in primary molars: an evidence based approach. Nuvvula, S., Bandi, M., Mallineni, SK.[2019]

In a study involving 120 rats, the combination of 20% formocresol (FMC) with zinc oxide-eugenol paste (ZOE) resulted in the least amount of pulpal inflammation after pulpotomy, indicating it may be the most effective treatment option.

Ferric sulfate (FS) did not enhance the pulpal healing response compared to FMC, suggesting that it may not be a superior alternative for pulpotomies in terms of reducing inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulpal tissue reaction to formocresol vs. ferric sulfate in pulpotomized rat teeth. Cotes, O., Boj, JR., Canalda, C., et al.[2012]

In a study involving 76 children aged 5-10, pulpotomy treatments using ferric sulfate (FS) and electrosurgery (ES) showed comparable success rates to the traditional formocresol (FC) method, with overall success rates of 82.1% and 83.3% respectively, compared to 87.5% for FC.

Both FS and ES are effective alternatives for treating cariously exposed pulps in primary molars, suggesting they can be safely used in clinical practice alongside the conventional method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three pulpotomy agents in primary molars: a randomised clinical trial. Farrokh Gisoure, E.[2022]

In a study involving 291 primary molars treated in 130 children, ferric sulfate pulpotomy (FS) showed poorer outcomes compared to primary tooth root canal therapy (RCT) at the 2-year follow-up, with more FS-treated molars classified as needing immediate extraction due to pathologic changes.

Despite the poorer outcomes for FS, both treatment methods demonstrated similar survival rates over the 2-year period, indicating that while FS may not be as effective, it does not lead to a higher risk of tooth loss compared to RCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes of primary molar ferric sulfate pulpotomy and root canal therapy. Casas, MJ., Layug, MA., Kenny, DJ., et al.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes of primary molar ferric sulfate pulpotomy and root canal therapy. [2016]

2. Italy pubmed.ncbi.nlm.nih.gov

Ferric Sulfate and Formocresol pulpotomies in paediatric dental practice. A prospective-retrospective study. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

Clinical and radiographic success rates of mineral trioxide aggregate and ferric sulphate pulpotomies performed by dental students. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Primary molar pulpotomies with different hemorrhage control agents and base materials: A randomized clinical trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of ferric sulphate as a pulpotomy medicament in primary molars: an evidence based approach. [2019]

6. Singapore pubmed.ncbi.nlm.nih.gov

Pulpal tissue reaction to formocresol vs. ferric sulfate in pulpotomized rat teeth. [2012]

7. Iran pubmed.ncbi.nlm.nih.gov

Comparison of three pulpotomy agents in primary molars: a randomised clinical trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Two-year outcomes of primary molar ferric sulfate pulpotomy and root canal therapy. [2012]