AzTrials
AzTrials

MTANCT03488316

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

A study testing Carie removal, Absolute isolation and Manipulation of the temporary filling material based on Calcium Hydroxide in people with MTA and Calcium Hydroxide, run by PAULO VINICIUS SOARES at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MTA, Calcium Hydroxide, Endodontic Treatment
What is being tested?
Carie removal, Absolute isolation and Manipulation of the temporary filling material based on Calcium Hydroxide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
1 May 2018to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy volunteers
  • Both genres
  • Presence of at least two teeth with indication of endodontic treatment
  • Good oral hygiene

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of Uberlandia

    Uberlândia, Minas Gerais, 381440617

Other trials in Brazil

About this study

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

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.

Read the detailed 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.

Being tested
Carie removal, Absolute isolation, Manipulation of the temporary filling material based on Calcium Hydroxide, Manipulation of the temporary filling material based on Mineral trioxide aggregate, Material insertion on the root canal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carie removalProcedure or surgery

    Carie removal with a low speed handpiece

  • Absolute isolationProcedure or surgery

    Absolute isolation with rubber dam

  • Manipulation of the temporary filling material based on Calcium HydroxideDrug

    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 aggregateDrug

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

  • Material insertion on the root canalProcedure or surgery

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

  • Material re-insertion on the root canal accordging to the infection needs.Procedure or surgery

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

  • Definiteve canal root obturationProcedure or surgery

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

  • Definitve restorationProcedure or surgery

    Definitve restoration confecction.

Study groups in NCT03488316
Study groupRoleWhat they receive
Calcium Hydroxide temporary filling materialActive comparatorTemporary filling with Ca(OH)2
Receives: Procedure: Carie removal; Procedure: Absolute isolation; Drug: Manipulation of the temporary filling material based on Calcium Hydroxide; Procedure: Material insertion on the root canal; Procedure: Material re-insertion on the root canal accordging to the infection needs.; Procedure: Definiteve canal root obturation; Procedure: Definitve restoration
MTA temporary filling materialActive comparatorTemporary filling with MTA
Receives: Procedure: Carie removal; Procedure: Absolute isolation; Drug: Manipulation of the temporary filling material based on Mineral trioxide aggregate; Procedure: Material insertion on the root canal; Procedure: Material re-insertion on the root canal accordging to the infection needs.; Procedure: Definiteve canal root obturation; Procedure: Definitve restoration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

    Measured: 1 year

  2. Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

    Measured: 1 year

  3. Presence of exudate between the treatment's sessions of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start1 May 2018 (estimated)
  3. Primary completion1 Jul 2018 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488316
Sponsor's protocol ID
2.527.632
Status last verified
Apr 2018
First submitted
6 Mar 2018
Last updated
10 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12184211

  • 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.

    PubMed 15766576

  • 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.

    PubMed 28561919

  • 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.

    PubMed 9467386

  • 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.

    PubMed 25722833

  • 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.

    PubMed 12017176

  • 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.

    PubMed 9477818

  • 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.

    PubMed 7800383

  • 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.

    PubMed 27377433

Questions about this trial

What is this clinical trial studying?

A study testing Carie removal, Absolute isolation and Manipulation of the temporary filling material based on Calcium Hydroxide in people with MTA and Calcium Hydroxide, run by PAULO VINICIUS SOARES at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488316, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.

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