Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments

Calcium Hydroxide Clinical Trial

Official title:

Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments - Randomized Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03488316
• Other study ID #: 2.527.632
• Status: Not yet recruiting
• Phase: N/A
• First received: March 6, 2018
• Last updated: April 6, 2018
• Start date: May 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2018
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The need for endodontic treatment is still very common in the clinical routine, whether due to dento-alveolar trauma or caries. In some cases, the temporary filling procedure is required until the endodontic treatment is completed. The temporary filling material should be biocompatible and bacteriostatic. The aim of this study is through a randomized clinical trial, double blind, split-mouth, 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. Twenty participants with at least two teeth with the need of endodontic treatment will be selected. The teeth will be randomly divided into 2 different groups according to the temporary filling material composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Both genres

• Presence of at least two teeth with indication of endodontic treatment

• Good oral hygiene

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Calcium Hydroxide
• Endodontic Treatment
• MTA

Intervention

Procedure:
• Carie removal
Carie removal with a low speed handpiece
• Absolute isolation
Absolute isolation with rubber dam

Drug:
• Manipulation of the temporary filling material based on Calcium Hydroxide
Manipulation of the temporary material based on Calcium Hydroxide according to the manufacturer's recommendations.
• Manipulation of the temporary filling material based on Mineral trioxide aggregate
Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations.

Procedure:
• Material insertion on the root canal
Material insertion on the root canal according to the manufacturer's recommendations
• Material re-insertion on the root canal accordging to the infection needs.
Material re-insertion on the root canal according to the manufacturer's recommendations
• Definiteve canal root obturation
Definiteve canal root obturation with gutta-percha and definitive cement.
• Definitve restoration
Definitve restoration confecction.

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
PAULO VINICIUS SOARES

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Barnett F. The role of endodontics in the treatment of luxated permanent teeth. Dent Traumatol. 2002 Apr;18(2):47-56. Review. — View Citation

Camilleri 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. — View Citation

da Rosa WLO, Cocco AR, Silva TMD, Mesquita LC, Galarça 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. Review. — View Citation

Le 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. — View Citation

Malkoç MA, DemIr N, Sengün 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. — View Citation

Siqueira JF Jr, Rôças IN, Santos SR, Lima KC, Magalhães 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. — View Citation

Sjögren 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. Erratum in: Int Endod J 1998 Mar;31(2):148. — View Citation

Sundqvist G. Taxonomy, ecology, and pathogenicity of the root canal flora. Oral Surg Oral Med Oral Pathol. 1994 Oct;78(4):522-30. Review. — View Citation

von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. Review. French, German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.		1 year
Primary	Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.		1 year
Primary	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