Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations (PBSCIMMO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03514264|
Recruitment Status : Unknown
Verified June 2018 by Rubia Moura Leite Boczar, Universidade do Vale do Sapucai.
Recruitment status was: Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Root Canal Therapy||Procedure: Gutta Percha and AHPLUS cement (group A) Procedure: PBS CIMMO cement (group B)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, interventional, prospective, unicentric, double blind clinical trial.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||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|
|Official Title:||Clinical Applicability of PBSCIMMO as a Single Material in Endodontic Obturations|
|Actual Study Start Date :||November 9, 2017|
|Estimated Primary Completion Date :||June 5, 2018|
|Estimated Study Completion Date :||February 26, 2019|
Experimental: GUTTA PERCHA and AHPLUS cement (group A)
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)
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
Experimental: PBS CIMMO cement (group B)
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)
Single intervention: endodontic instrumentation and obturation with cement PBS CIMMO
- Patients with necrotic teeth and periradicular lesion evaluated by cone beam tomography [ Time Frame: Patients will return six months after the procedure to undergo a exam cone Beam tomografy ]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
- Clinical examination of patients' treated teeth [ Time Frame: Patients will return six months after the procedure to undergo a clinical examination ]The physiological parameter for this examination will be the absence of fistula that will determine treatment success
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514264
|Rubia Moura Leite Boczar|
|Pouso Alegre, MG, Brazil, 37550000|
|Principal Investigator:||Rubia Boczar||Univás-Universidade do Vale do Sapucaí- Pouso Alegre Minas Geraes|
|Study Director:||Taylor b Schnaider, MD,PhD||Universidade Vale do Sapucaí|
|Study Chair:||Daniela F Veiga, MD,PhD||Universidade Vale do Sapucaí|