Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this study is through a randomized clinical trial, double blind, splitmouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedApril 10, 2018
April 1, 2018
2 months
March 6, 2018
April 6, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
1 year
Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
1 year
Presence of exudate between the treatment's sessions of endodontically treated teeth that required filling with temporary material with a 1 year follow up.
1 year
Study Arms (2)
Calcium Hydroxide temporary filling material
ACTIVE COMPARATORTemporary filling with Ca(OH)2
MTA temporary filling material
ACTIVE COMPARATORTemporary filling with MTA
Interventions
Carie removal with a low speed handpiece
Absolute isolation with rubber dam
Manipulation of the temporary material based on Calcium Hydroxide according to the manufacturer's recommendations.
Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations.
Material insertion on the root canal according to the manufacturer's recommendations
Material re-insertion on the root canal according to the manufacturer's recommendations
Definiteve canal root obturation with gutta-percha and definitive cement.
Definitve restoration confecction.
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Both genres
- Presence of at least two teeth with indication of endodontic treatment
- Good oral hygiene
You may not qualify if:
- Dentures or orthodontics
- Presence of periodontal disease
- Presence of parafunctional habits
- Presence of systemic disease
- Presence of severe psychological disturbe;
- Constant use of analgesic and, or anti-inflammatory
- Allergic response to dental products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Uberlandia
Uberlândia, Minas Gerais, 381440617, Brazil
Related Publications (9)
Barnett F. The role of endodontics in the treatment of luxated permanent teeth. Dent Traumatol. 2002 Apr;18(2):47-56. doi: 10.1034/j.1600-9657.2002.00098.x.
PMID: 12184211BACKGROUNDCamilleri J, Montesin FE, Brady K, Sweeney R, Curtis RV, Ford TR. The constitution of mineral trioxide aggregate. Dent Mater. 2005 Apr;21(4):297-303. doi: 10.1016/j.dental.2004.05.010.
PMID: 15766576BACKGROUNDda Rosa WLO, Cocco AR, Silva TMD, Mesquita LC, Galarca AD, Silva AFD, Piva E. Current trends and future perspectives of dental pulp capping materials: A systematic review. J Biomed Mater Res B Appl Biomater. 2018 Apr;106(3):1358-1368. doi: 10.1002/jbm.b.33934. Epub 2017 May 31.
PMID: 28561919BACKGROUNDLe Goff A, Bunetel L, Mouton C, Bonnaure-Mallet M. Evaluation of root canal bacteria and their antimicrobial susceptibility in teeth with necrotic pulp. Oral Microbiol Immunol. 1997 Oct;12(5):318-22. doi: 10.1111/j.1399-302x.1997.tb00397.x.
PMID: 9467386BACKGROUNDMalkoc MA, DemIr N, Sengun A, Bozkurt SB, Hakki SS. Cytotoxicity of temporary cements on bovine dental pulp-derived cells (bDPCs) using realtime cell analysis. J Adv Prosthodont. 2015 Feb;7(1):21-6. doi: 10.4047/jap.2015.7.1.21. Epub 2015 Feb 17.
PMID: 25722833BACKGROUNDSiqueira JF Jr, Rocas IN, Santos SR, Lima KC, Magalhaes FA, de Uzeda M. Efficacy of instrumentation techniques and irrigation regimens in reducing the bacterial population within root canals. J Endod. 2002 Mar;28(3):181-4. doi: 10.1097/00004770-200203000-00009.
PMID: 12017176BACKGROUNDSjogren U, Figdor D, Persson S, Sundqvist G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. Int Endod J. 1997 Sep;30(5):297-306. doi: 10.1046/j.1365-2591.1997.00092.x.
PMID: 9477818BACKGROUNDSundqvist G. Taxonomy, ecology, and pathogenicity of the root canal flora. Oral Surg Oral Med Oral Pathol. 1994 Oct;78(4):522-30. doi: 10.1016/0030-4220(94)90047-7.
PMID: 7800383BACKGROUNDvon Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. doi: 10.61872/sdj-2016-06-02. French, German.
PMID: 27377433BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of NCCL Research Group
Study Record Dates
First Submitted
March 6, 2018
First Posted
April 5, 2018
Study Start
May 1, 2018
Primary Completion
July 1, 2018
Study Completion
December 30, 2019
Last Updated
April 10, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share