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

NCT ID: NCT03488316

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

MTA Calcium Hydroxide Endodontic Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Calcium Hydroxide temporary filling material

Temporary filling with Ca(OH)2

Group Type ACTIVE_COMPARATOR

Carie removal

Intervention Type PROCEDURE

Carie removal with a low speed handpiece

Absolute isolation

Intervention Type PROCEDURE

Absolute isolation with rubber dam

Manipulation of the temporary filling material based on Calcium Hydroxide

Intervention Type DRUG

Manipulation of the temporary material based on Calcium Hydroxide according to the manufacturer's recommendations.

Material insertion on the root canal

Intervention Type PROCEDURE

Material insertion on the root canal according to the manufacturer's recommendations

Material re-insertion on the root canal accordging to the infection needs.

Intervention Type PROCEDURE

Material re-insertion on the root canal according to the manufacturer's recommendations

Definiteve canal root obturation

Intervention Type PROCEDURE

Definiteve canal root obturation with gutta-percha and definitive cement.

Definitve restoration

Intervention Type PROCEDURE

Definitve restoration confecction.

MTA temporary filling material

Temporary filling with MTA

Group Type ACTIVE_COMPARATOR

Carie removal

Intervention Type PROCEDURE

Carie removal with a low speed handpiece

Absolute isolation

Intervention Type PROCEDURE

Absolute isolation with rubber dam

Manipulation of the temporary filling material based on Mineral trioxide aggregate

Intervention Type DRUG

Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations.

Material insertion on the root canal

Intervention Type PROCEDURE

Material insertion on the root canal according to the manufacturer's recommendations

Material re-insertion on the root canal accordging to the infection needs.

Intervention Type PROCEDURE

Material re-insertion on the root canal according to the manufacturer's recommendations

Definiteve canal root obturation

Intervention Type PROCEDURE

Definiteve canal root obturation with gutta-percha and definitive cement.

Definitve restoration

Intervention Type PROCEDURE

Definitve restoration confecction.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carie removal

Carie removal with a low speed handpiece

Intervention Type PROCEDURE

Absolute isolation

Absolute isolation with rubber dam

Intervention Type PROCEDURE

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Material insertion on the root canal

Material insertion on the root canal according to the manufacturer's recommendations

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Definiteve canal root obturation

Definiteve canal root obturation with gutta-percha and definitive cement.

Intervention Type PROCEDURE

Definitve restoration

Definitve restoration confecction.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PAULO VINICIUS SOARES

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PAULO VINICIUS SOARES

Director of NCCL Research Group

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12184211 (View on PubMed)

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. doi: 10.1016/j.dental.2004.05.010.

Reference Type BACKGROUND
PMID: 15766576 (View on PubMed)

da 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.

Reference Type BACKGROUND
PMID: 28561919 (View on PubMed)

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. doi: 10.1111/j.1399-302x.1997.tb00397.x.

Reference Type BACKGROUND
PMID: 9467386 (View on PubMed)

Malkoc 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.

Reference Type BACKGROUND
PMID: 25722833 (View on PubMed)

Siqueira 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.

Reference Type BACKGROUND
PMID: 12017176 (View on PubMed)

Sjogren 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.

Reference Type BACKGROUND
PMID: 9477818 (View on PubMed)

Sundqvist 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.

Reference Type BACKGROUND
PMID: 7800383 (View on PubMed)

von 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.

Reference Type BACKGROUND
PMID: 27377433 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2.527.632

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biodentine Versus White MTA Pulpotomy
NCT01733420 COMPLETED PHASE3