MTANCT03491527
Influence of Resin Cement Composition on the Longevity of Intraradicular Post of Endodontically Treated Teeth
A study testing Absolute isolation, Manipulation of the resin cement with MTA and Manipulation of the resin cement without MTA in people with MTA and Endodontically Treated Teeth, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MTA, Endodontically Treated Teeth, Resin Cement
- What is being tested?
- Absolute isolation, Manipulation of the resin cement with MTA and Manipulation of the resin cement without MTA
- 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 Jul 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;
- Presence of at least two teeth with endodontc treatment;
- Presence of at least two teeth with indication of total crowns;
- Good oral hygiene.
Who cannot join
- Dentures or orthodontics;
- Presence of periodontal disease
- Presence of parafunctional habits
- Presence of systemic disease
- 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
About this study
Official title: Influence of Resin Cement Composition on the Longevity of Intraradicular Post in the Rehabilitation of Endodontically Treated Teeth - Randomized Clinical Trials
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.
Read the detailed description
Endodontically treated teeth present an increased risk of fracture and are usually related to extensive carious processes or trauma that promote major coronary destruction. In such situations, it may be necessary to indicate intra-radicular retainers, such as fiberglass pins, to retain the restorative material. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. Twenty participants with at least two teeth with endodontic treatment with need intraradicular post cementation and confection of indirect dental crown (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to resin cement composition (with and without mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.
- Conditions
- MTA, Endodontically Treated Teeth, Resin Cement
- Being tested
- Absolute isolation, Manipulation of the resin cement with MTA, Manipulation of the resin cement without MTA, Fiber Post cimentation, Dental Prepare
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absolute isolationProcedure or surgery
Absolute isolation with rubber dam
Manipulation of the resin cement with MTAProcedure or surgery
Manipulation of the resin cement with MTA according to the manufacturer's recommendations.
Manipulation of the resin cement without MTAProcedure or surgery
Manipulation of the resin cement without MTA according to the manufacturer's recommendations.
Fiber Post cimentationProcedure or surgery
Insertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface.
Dental PrepareProcedure or surgery
Confection of a indirect crown prepare with diamand burs.
Dental impressionProcedure or surgery
Dental impression whith silicone.
Crown cimentationProcedure or surgery
Insertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface.
Occlusal adjustmentProcedure or surgery
Analysis of the occlusion with carbon paper.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Resin Cement | Active comparator | Resin cement without MTA Receives: Procedure: Absolute isolation; Procedure: Manipulation of the resin cement without MTA; Procedure: Fiber Post cimentation; Procedure: Dental Prepare; Procedure: Dental impression; Procedure: Crown cimentation; Procedure: Occlusal adjustment |
| MTA Resin Cement | Active comparator | Resin cement with MTA Receives: Procedure: Absolute isolation; Procedure: Manipulation of the resin cement with MTA; Procedure: Fiber Post cimentation; Procedure: Dental Prepare; Procedure: Dental impression; Procedure: Crown cimentation; Procedure: Occlusal adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns 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.
- First posted9 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MTAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PAULO VINICIUS SOARES, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491527
- Sponsor's protocol ID
- 2.570.182
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Assif D, Gorfil C. Biomechanical considerations in restoring endodontically treated teeth. J Prosthet Dent. 1994 Jun;71(6):565-7. doi: 10.1016/0022-3913(94)90438-3.
PubMed 8040817Bahari M, Savadi Oskoee S, Kimyai S, Mohammadi N, Saati Khosroshahi E. Effect of Light Intensity on the Degree of Conversion of Dual-cured Resin Cement at Different Depths with the use of Translucent Fiber Posts. J Dent (Tehran). 2014 May;11(3):248-55. Epub 2014 May 31.
PubMed 25628659Camilleri 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 15766576Christensen GJ. Post concepts are changing. J Am Dent Assoc. 2004 Sep;135(9):1308-10. doi: 10.14219/jada.archive.2004.0406.
PubMed 15493395Duarte MA, De Oliveira Demarchi AC, Yamashita JC, Kuga MC, De Campos Fraga S. Arsenic release provided by MTA and Portland cement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 May;99(5):648-50. doi: 10.1016/j.tripleo.2004.09.015.
PubMed 15829892Lee SJ, Monsef M, Torabinejad M. Sealing ability of a mineral trioxide aggregate for repair of lateral root perforations. J Endod. 1993 Nov;19(11):541-4. doi: 10.1016/S0099-2399(06)81282-3.
PubMed 8151240Santos-Filho PC, Castro CG, Silva GR, Campos RE, Soares CJ. Effects of post system and length on the strain and fracture resistance of root filled bovine teeth. Int Endod J. 2008 Jun;41(6):493-501. doi: 10.1111/j.1365-2591.2008.01383.x. Epub 2008 Apr 12.
PubMed 18422584von 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Resin Cement Composition on the Longevity of Intraradicular Post in the Rehabilitation of Endodontically Treated Teeth - Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT03491527
- Acronym / sponsor ID
- 2.570.182
- Conditions
- MTA, Endodontically Treated Teeth, Resin Cement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.
Detailed description
Endodontically treated teeth present an increased risk of fracture and are usually related to extensive carious processes or trauma that promote major coronary destruction. In such situations, it may be necessary to indicate intra-radicular retainers, such as fiberglass pins, to retain the restorative material. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. Twenty participants with at least two teeth with endodontic treatment with need intraradicular post cementation and confection of indirect dental crown (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to resin cement composition (with and without mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Resin Cement | Active comparator | Procedure: Absolute isolation, Procedure: Manipulation of the resin cement without MTA, Procedure: Fiber Post cimentation, Procedure: Dental Prepare, Procedure: Dental impression, Procedure: Crown cimentation, Procedure: Occlusal adjustmentResin cement without MTA |
| MTA Resin Cement | Active comparator | Procedure: Absolute isolation, Procedure: Manipulation of the resin cement with MTA, Procedure: Fiber Post cimentation, Procedure: Dental Prepare, Procedure: Dental impression, Procedure: Crown cimentation, Procedure: Occlusal adjustmentResin cement with MTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers;
- Presence of at least two teeth with endodontc treatment;
- Presence of at least two teeth with indication of total crowns;
- Good oral hygiene.
Key exclusion criteria (6 listed)
- Dentures or orthodontics;
- Presence of periodontal disease
- Presence of parafunctional habits
- Presence of systemic disease
- Constant use of analgesic and or anti-inflammatory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absolute isolationAbsolute isolation with rubber dam | Procedure or surgery | Conventional Resin Cement, MTA Resin Cement |
| Manipulation of the resin cement with MTAManipulation of the resin cement with MTA according to the manufacturer's recommendations. | Procedure or surgery | MTA Resin Cement |
| Manipulation of the resin cement without MTAManipulation of the resin cement without MTA according to the manufacturer's recommendations. | Procedure or surgery | Conventional Resin Cement |
| Fiber Post cimentationInsertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface. | Procedure or surgery | Conventional Resin Cement, MTA Resin Cement |
| Dental PrepareConfection of a indirect crown prepare with diamand burs. | Procedure or surgery | Conventional Resin Cement, MTA Resin Cement |
| Dental impressionDental impression whith silicone. | Procedure or surgery | Conventional Resin Cement, MTA Resin Cement |
| Crown cimentationInsertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface. | Procedure or surgery | Conventional Resin Cement, MTA Resin Cement |
| Occlusal adjustmentAnalysis of the occlusion with carbon paper. | Procedure or surgery | Conventional Resin Cement, MTA Resin Cement |
Primary outcome
Success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns with a 1 year follow up.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Background: PubMed 8040817Assif D, Gorfil C. Biomechanical considerations in restoring endodontically treated teeth. J Prosthet Dent. 1994 Jun;71(6):565-7. doi: 10.1016/0022-3913(94)90438-3.
- Background: PubMed 25628659Bahari M, Savadi Oskoee S, Kimyai S, Mohammadi N, Saati Khosroshahi E. Effect of Light Intensity on the Degree of Conversion of Dual-cured Resin Cement at Different Depths with the use of Translucent Fiber Posts. J Dent (Tehran). 2014 May;11(3):248-55. Epub 2014 May 31.
- Background: PubMed 15766576Camilleri 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.
- Background: PubMed 15493395Christensen GJ. Post concepts are changing. J Am Dent Assoc. 2004 Sep;135(9):1308-10. doi: 10.14219/jada.archive.2004.0406.
- Background: PubMed 15829892Duarte MA, De Oliveira Demarchi AC, Yamashita JC, Kuga MC, De Campos Fraga S. Arsenic release provided by MTA and Portland cement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 May;99(5):648-50. doi: 10.1016/j.tripleo.2004.09.015.
- Background: PubMed 8151240Lee SJ, Monsef M, Torabinejad M. Sealing ability of a mineral trioxide aggregate for repair of lateral root perforations. J Endod. 1993 Nov;19(11):541-4. doi: 10.1016/S0099-2399(06)81282-3.
- Background: PubMed 18422584Santos-Filho PC, Castro CG, Silva GR, Campos RE, Soares CJ. Effects of post system and length on the strain and fracture resistance of root filled bovine teeth. Int Endod J. 2008 Jun;41(6):493-501. doi: 10.1111/j.1365-2591.2008.01383.x. Epub 2008 Apr 12.
- Background: PubMed 27377433von 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absolute isolation, Manipulation of the resin cement with MTA and Manipulation of the resin cement without MTA in people with MTA and Endodontically Treated Teeth, run by Federal University of Uberlandia 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 6 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 9 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?
Success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns with a 1 year follow up. (time frame: 1 year). 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 NCT03491527, which also lists 8 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 9 Apr 2018.