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

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two materials used in dental procedures for treating toothaches in young children. It aims to determine if a non-eugenol material (without a certain oil that might cause issues) is more effective than the traditional eugenol-based material. The study focuses on children ages 3 to 7 with cavities and signs of reversible pulpitis (an early stage of tooth nerve inflammation) but no severe tooth damage. The goal is to find a better way to treat primary teeth and prevent future problems. As an Early Phase 1 trial, this research seeks to understand how the treatment works in young children, offering a chance to be among the first to benefit from new dental care advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies tested a material called eugenol-based zinc oxide (ZOE) for dental treatments like pulpotomies, which address tooth decay. These studies found that eugenol-based ZOE alone had a low success rate over 24 months. For example, one study showed that out of 60 procedures, only 51 were successful, indicating some reliability issues.

In contrast, the non-eugenol based ZOE is newer and less studied. Researchers are exploring whether it might avoid problems associated with eugenol, such as treatment failure. This trial is in the early stages of research (Early Phase 1), focusing on testing the safety of non-eugenol based ZOE combined with ferric sulfate. This phase typically checks for safety and any side effects, but detailed information from human studies might not yet be available. Participating in such early trials often means the treatment is being tested in people for the first time, so the complete safety profile remains unknown. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for toothache in primary molars because they explore the use of zinc oxide eugenol (ZOE) materials in a new way. One treatment uses non-eugenol based ZOE combined with Ferric Sulfate, while the other uses eugenol based ZOE with Ferric Sulfate. Unlike the traditional use of formocresol in pulpotomy procedures, these treatments aim to reduce potential irritation and improve biocompatibility. The unique combination of materials may enhance healing and provide effective pain relief, making them promising alternatives to current options.

What evidence suggests that this trial's treatments could be effective for toothache?

Research has shown that using zinc oxide without eugenol in pulpotomies might help avoid problems linked to eugenol. Eugenol-based materials have been associated with issues seen in X-rays when treating children's molars. This trial will compare two treatment arms: one using non-eugenol-based zinc oxide with Ferric Sulfate, and another using eugenol-based zinc oxide with Ferric Sulfate, to evaluate their effectiveness in primary molar pulpotomy procedures. Although eugenol-based zinc oxide has been used for a long time, some studies have shown mixed results, especially over the long term. By avoiding eugenol, the researchers aim to improve the success of these treatments in children's teeth. ^{1 2 4 6 7}

Who Is on the Research Team?

Jayakumar Jayaraman, BDS MDS PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulpotomy procedures using either non-eugenol based ZOE and Ferric Sulfate or eugenol based zinc oxide and Ferric Sulfate

1-2 weeks

Follow-up

Participants are monitored for radiographic and clinical success of the pulpotomy procedures

36 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8469668/

Zinc Oxide Zinc Sulfate versus Zinc Oxide Eugenol as Pulp ... This study compared the success rates of Zinc oxide zinc sulfate and zinc oxide eugenol as coronal dressing materials post radicular pulp amputation in primary ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05792748

Comparison of Zinc Oxide Eugenol to Ferric Sulphate ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38449041/

Use of Vital Pulp Therapies in Primary Teeth 2024 The purpose of this study was to present an evidence-based guideline for primary teeth with deep caries or trauma requiring vital pulp therapies (VPT).

4. jocpd.com jocpd.com/articles/10.17796/1053-4628-40.2.107

Zinc Oxide−Eugenol Pulpotomy in Primary Teeth Results: After a 24-month follow-up, we considered 51 procedures to be successful and 9 failures using clinical and radiographic criteria; most ...

5. clinicaltrial.be clinicaltrial.be/fr/details/191446?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Clinical Trial Comparing FS With ZOE and Non-eugenol ... 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 ...

6. aapd.org aapd.org/globalassets/media/policies_guidelines/g_vpt-2024.pdf

Use of Vital Pulp Therapies in Primary Teeth 2024 It was conditionally recommended against using zinc oxide eugenol (ZOE) as the sole pulpotomy medica- ment given its very low success at 24 months. Sodium hypo-.

7. mdpi.com mdpi.com/2077-0383/11/1/85

Vital and Nonvital Pulp Therapy in Primary Dentition Zinc oxide eugenol (ZOE) pulpectomies yielded similar outcome than Vitapex and Sealapex, with moderate methodological confidence [14]. A systematic review from ...