A Comparative Assessment Clinical Trial Comparing Ferric Sulfate With Zinc-oxide Eugenol and Non-eugenol Based Materials for Pulpotomy in Primary Molar Teeth

HM20024506

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.

2023-02-02

2024-07-01

2025-05-01

Recruiting

Early phase I

150

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-06-11