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An Alksite Composite material to Restore Endodontically Treated Teeth: A randomized control trial study

Evaluation of a Bioactive Composite for the Restoration of Endodontically Treated Teeth: A Prospective Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-97kx5jv
Enrollment
Unknown
Registered
2023-01-19
Start date
2021-10-01
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

Dental Restoration Wear

Interventions

This is a parallel randomized controlled clinical trial, Unicego. Patients are assigned to intervention groups using a table of random numbers in an excel spreadsheet. The sample will be composed of p

Sponsors

Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo - FORP USP
Lead Sponsor
Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo - FORP USP
Collaborator

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Both genders; Presence of 1 lower molar (First or Second) treated endodontically requiring direct restoration; Endodontic treatment performed for a maximum of 6 months; Presence of antagonist tooth in the dental arch; No parafunctional habits; No temporomandibular disorder; age 18 to 40 years

Exclusion criteria

Exclusion criteria: Teeth with extensive loss with indication of indirect restorations were excluded from the study; teeth with root involvement such as fractures or cracks, patients with poor oral hygiene, patients with chronic or aggressive periodontitis, teeth that were endodontically treated for more than 6 months and teeth without provisional cavity sealing

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: It is expected that the use of the bioactive composite does not influence the restorative treatment of endodontically treated teeth, presenting results similar to composite resins in the criteria of Retention, marginal discoloration, caries recurrence, restoration color, marginal pigmentation, anatomical shape , and similarity in radiographic success (adequate contact point, absence of radiolucent line, absence of lacks and excesses);Outcome found 1: Greater wear of the anatomical shape and color difference was observed in the period of 6 months for the group that received the bioactive composite, compared to the material used for the control group (Composite Resin) verified by means of the modified USPHS criteria, between the pre and post-intervention periods. The other criteria such as retention, marginal discoloration, caries recurrence, marginal pigmentation, and radiographic success, both materials showed the same results by the evaluation

Secondary

MeasureTime frame
Secondary endpoints are not expected

Countries

Brazil

Contacts

Public ContactSilmara Corona

Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo - FORP USP

silmaracorona@forp.usp.br+55 (16) 3315-3955

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026