Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations

NCT03514264 | Unknown

• 1 other identifier: PBS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, interventional, prospective, unicentric clinical study, 86 patients will be submitted to endodontic treatment of necrotic teeth. 43 patients will complete treatment with obturation with AHPlus cement and Gutta-Percha cones (group A) and 43 patients will complete treatment with PBS® CIMMO cement (single material) (group B). The primary outcome will be the repair of the periradicular lesion demonstrated by integrity of the hard blade throughout the perimeter of the root identified by Tomography Cone Beam, performed after 6 months of treatment. The secondary endpoint will be the absence of fistula after 6 months of treatment identified by clinical examination.

Conditions

Root Canal Therapy

Keywords

Endodontics; Biomaterials; Dental pulp cavity; Periapical abscess; Root canal therapy; Root canal obturation

Outcome Measures

Primary Outcomes (1)

• Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography

  The data will be aggregated by presence of hard blade that determines the phylogenetic parameter of success of the treatment. This physiological parameter is the presence of hard blade integrated in the tomography image, which will determine healthy periodontal ligament

  Patients will return six months after the procedure to undergo a exam cone Beam tomografy

Secondary Outcomes (1)

• Clinical examination of patients' treated teeth

  Patients will return six months after the procedure to undergo a clinical examination

Study Arms (2)

GUTTA PERCHA and AHPLUS cement (group A)

EXPERIMENTAL

43 patients will undergo endodontic treatment with obturation with AHPlus cement and Gutta-Percha cones. This treatment will be performed in 2 sessions. First intervention: endodontic instrumentation and introduction of intra-canal medication that will remain in the tooth for 4 weeks. Second intervention: removal of intracanal medication and filling with cement and gutta percha AHPlus.

Procedure: Gutta Percha and AHPLUS cement (group A)

PBS CIMMO cement (group B)

EXPERIMENTAL

43 patients will undergo endodontic treatment with PBS CIMMO® cement (single material).This treatment will be performed in 1 session.Single intervention: endodontic instrumentation and cement filling PBS CIMMO.

Procedure: PBS CIMMO cement (group B)

Interventions

Gutta Percha and AHPLUS cement (group A) PROCEDURE

First intervention: endodontic instrumentation and introduction of intact medication that will remain inside the tooth for 4 weeks. Second intervention: removal of intracanal medication and canal filling with cement AHPLUS and guttapercha

GUTTA PERCHA and AHPLUS cement (group A)

PBS CIMMO cement (group B) PROCEDURE

Single intervention: endodontic instrumentation and obturation with cement PBS CIMMO

PBS CIMMO cement (group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients presenting with a diagnosis of necrosis.

You may not qualify if:

• Patients who drop out during the study
• Patients who do not return to the final exam after 6 months.
• Patients who present more than one tooth in need of treatment will choose only one tooth, the others will be excluded.

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Rubia Moura Leite Boczar

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

MeSH Terms

Conditions

Dental Caries; Periapical Abscess

Interventions

Gutta-Percha

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Abscess; Suppuration; Infections; Periapical Periodontitis; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Plant Exudates; Biological Products; Complex Mixtures; Root Canal Filling Materials; Dental Materials; Biomedical and Dental Materials; Rubber; Elastomers; Polymers; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Rubia Boczar

  Univás-Universidade do Vale do Sapucaí- Pouso Alegre Minas Geraes

  PRINCIPAL INVESTIGATOR

• Taylor b Schnaider, MD,PhD

  Universidade Vale do Sapucaí

  STUDY DIRECTOR

• Daniela F Veiga, MD,PhD

  Universidade Vale do Sapucaí

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After 6 months the results will be evaluated by two independent professionals, who did not participate in the interventions and are not aware of the allocation. The evaluation will be performed by means of tomography and clinical examination
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A randomized, interventional, prospective, unicentric, double blind clinical trial.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: May 2, 2018
• Study Start: November 9, 2017
• Primary Completion: June 5, 2018
• Study Completion: February 26, 2019
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)