A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies

NCT05557812 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HM20024506
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (2)

• Clinical success rate

  The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility.

  36 months

• Radiographic success rate

  1. Normal periodontal ligament space 2. No inter-radicular or periapical radiolucency 3. No internal or external root resorption

  36 months

Study Arms (2)

non-eugenol based ZOE and Ferric Sulfate

EXPERIMENTAL

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

Drug: non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies

eugenol based zinc oxide and Ferric Sulfate

EXPERIMENTAL

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

Drug: eugenol based zinc oxide and Ferric Sulfate

Interventions

non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies DRUG

non-eugenol based ZOE base material placed over ferric sulphate, during vital pulp therapy (pulpotomy) in primary molars

Also known as: CAVIT

non-eugenol based ZOE and Ferric Sulfate

eugenol based zinc oxide and Ferric Sulfate DRUG

eugenol based zinc oxide base material placed over Ferric Sulfate medicament, during vital pulp therapy (pulpotomy) in primary molars

Also known as: Intermediate Restorative Material (IRM)

eugenol based zinc oxide and Ferric Sulfate

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 7 years old.
• Carious teeth with clinical and radiographic diagnosis of reversible pulpitis
• Only teeth having no more than one third of their roots undergoing physiologic resorption were included.
• Restorable with stainless steel crown

You may not qualify if:

• clinical or radiographic evidence of pulp degeneration
• excessive bleeding
• pathologic mobility
• swelling or fistula
• history of spontaneous and nocturnal pain
• tenderness to percussion or palpation
• external or internal root resorption : {The primary teeth undergo resorption due to developing permanent teeth which is considered normal. Presence of internal root resorption will be considered as a failure (pathological change). Alternatively external root resorption will not be considered as a failure (physiological change}
• inter radicular or periapical radiolucency.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pulpitis

Interventions

ferric sulfate; Cavit

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jayakumar Jayaraman, BDS MDS PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 28, 2022
• Study Start: February 2, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)