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Paste based on Zinc Oxide, Iodoform and Calcium Hydroxide Manipulated for filling root canals of primary teeth: double-blind randomized controlled clinical study

Paste based on Zinc Oxide, Iodoform, and Calcium Hydroxide Manipulated for root canal filling of deciduous teeth: a double-blind randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2r72f8v
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-10-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis

Interventions

This is a double-blind, randomized controlled clinical study. A total of 45 children who meet the eligibility criteria will be probabilistically allocated to one or another intervention group using an

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: Children of both sexes; aged between 3 and 8 years; who have at least one deciduous lower molar diagnosed with irreversible pulpitis or pulp necrosis resulting from deep caries lesions with indication for radical endodontic treatment (pulpectomy)

Exclusion criteria

Exclusion criteria: Children with systemic involvement; who have a history of allergy to local anesthesia or any component present in the materials to be used; the deciduous lower molar presents radiographic signs of involvement of the crypt of the permanent successor tooth germ; the deciduous lower molar presents extensive coronal destruction that cannot be restored; the deciduous lower molar presents extensive coronal destruction that cannot be isolated; the deciduous lower molar presents pathological mobility; the deciduous lower molar presents root resorption greater than one third of the root; the deciduous lower molar presents a perforated pulp floor; the deciduous lower molar presents radiographic evidence of excessive internal or external root resorption; the deciduous lower molar presents excessive bone loss in the bifurcation area involving the underlying permanent successor tooth germ; the deciduous lower molar presents some of the root canals obliterated; the deciduous lower molar has undergone previous endodontic treatment

Design outcomes

Primary

MeasureTime frame
To evaluate the properties and clinical and radiographic success rates of root canal filling of endodontically treated deciduous teeth by comparing a compounded paste containing zinc oxide, iodoform and calcium hydroxide with eugenol as a vehicle with the Endoflas F.S. paste and a paste based on zinc oxide and eugenol (OZE), through a randomized non-inferiority clinical trial

Secondary

MeasureTime frame
To monitor the clinical and radiographic evolution of deciduous teeth treated endodontically with the Manipulated Paste containing Zinc Oxide, Iodoform and Calcium Hydroxide with Eugenol as vehicle, comparing with Endoflas F.S. and OZE at times of 7 days, 3, 6, 12, 18 and 24 months;To verify the reabsorption rate (similar to rhizolysis or when extravasated beyond the apex) of the Manipulated Paste containing Zinc Oxide, Iodoform and Calcium Hydroxide with Eugenol as a vehicle as a root canal filling cement for deciduous teeth, comparing it with Endoflas F.S. and OZE

Countries

Brazil

Contacts

Public ContactPriscilla Campos

Universidade Federal de Minas Gerais

priscillasenasouza@hotmail.com+55-31-994050524

Outcome results

None listed

Source: REBEC (via WHO ICTRP)