MTANCT03437655
Influence of the Composition of Temporary Restorative Material in Vital Teeth
A study testing Carie removal, Relative isolation and Manipulation of the temporary material based on Zinc Oxide and Eugenol in people with MTA and Dental Restoration, Temporary, 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 (retation rate and dental sensibility) of temporary direct restorations in vital teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MTA, Dental Restoration, Temporary
- What is being tested?
- Carie removal, Relative isolation and Manipulation of the temporary material based on Zinc Oxide and Eugenol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Mar 2018to 30 Oct 2018
- 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 direct restoration; good oral hygiene.
Who cannot join
- Dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or 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 the Composition of Temporary Restorative Material on the Retention Rate and Sensitivity for Provisional Direct Restorations in Vital Teeth - Clinical Study Randomized
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retation rate and dental sensibility) of temporary direct restorations in vital teeth. The composition of the temporary direct restoration (based on Zinc-Oxide with Eugenol; and mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.
Read the detailed description
The confection of temporary direct restoration is still verry commom in dental clinic routine, either by the time required or by biological requirements.The temporary restorations must have sufficient retention and solubility between the consultation intervals to avoid displacement and infiltration; besides being biocompatible to avoid sensitivity. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retention rate and dental sensibility) of temporary direct restoration on vital teeth. The composition of the temporary material (based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate) will be evaluated. Twenty-five participants with at least two vital teeth with the need to confection of direct restoration (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to the temporary material composition (Based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.
- Conditions
- MTA, Dental Restoration, Temporary
- Being tested
- Carie removal, Relative isolation, Manipulation of the temporary material based on Zinc Oxide and Eugenol, Manipulation of the temporary material based on Mineral trioxide aggregate, Material insertion on the cavity
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
Relative isolationProcedure or surgery
Relative isolation with cotton and gauze.
Manipulation of the temporary material based on Zinc Oxide and EugenolProcedure or surgery
Manipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations
Manipulation of the temporary material based on Mineral trioxide aggregateProcedure or surgery
Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations
Material insertion on the cavityProcedure or surgery
Material insertion on the cavity according to the manufacturer's recommendations
Finishing the temporary direct restorationProcedure or surgery
Excess cement removal; Occlusal Adjustment; Finishing and polishing.
| Study group | Role | What they receive |
|---|---|---|
| Zinc oxide and eugenol | Active comparator | Temporary direct restoration with zinc oxide and eugenol. Receives: Procedure: Carie removal; Procedure: Relative isolation; Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol; Procedure: Material insertion on the cavity; Procedure: Finishing the temporary direct restoration |
| Mineral trioxide aggregate | Active comparator | Temporary direct restoration with Mineral trioxide aggregate. Receives: Procedure: Carie removal; Procedure: Relative isolation; Procedure: Manipulation of the temporary material based on Mineral trioxide aggregate; Procedure: Material insertion on the cavity; Procedure: Finishing the temporary direct restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate (retention rate and absence of sensibility) of temporary direct restoration with diferents temporary materials with a 15 days of follow up
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start20 Mar 2018 (estimated)
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- 25 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
- NCT03437655
- Sponsor's protocol ID
- 2.358.776
- Status last verified
- Mar 2018
- First submitted
- 11 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Jabbari YS, Al-Rasheed A, Smith JW, Iacopino AM. An indirect technique for assuring simplicity and marginal integrity of provisional restorations during full mouth rehabilitation. Saudi Dent J. 2013 Jan;25(1):39-42. doi: 10.1016/j.sdentj.2012.10.003. Epub 2012 Nov 10.
PubMed 23960554Arora SJ, Arora A, Upadhyaya V, Jain S. Comparative evaluation of marginal leakage of provisional crowns cemented with different temporary luting cements: In vitro study. J Indian Prosthodont Soc. 2016 Jan-Mar;16(1):42-8. doi: 10.4103/0972-4052.164911.
PubMed 27134427Fonseca RB, Martins LR, Quagliatto PS, Soares CJ. Influence of provisional cements on ultimate bond strength of indirect composite restorations to dentin. J Adhes Dent. 2005 Autumn;7(3):225-30.
PubMed 16240963Hill EE, Lott J. A clinically focused discussion of luting materials. Aust Dent J. 2011 Jun;56 Suppl 1:67-76. doi: 10.1111/j.1834-7819.2010.01297.x.
PubMed 21564117Koumjian JH, Nimmo A. Evaluation of fracture resistance of resins used for provisional restorations. J Prosthet Dent. 1990 Dec;64(6):654-7. doi: 10.1016/0022-3913(90)90290-s.
PubMed 2079670Mahn E, Rousson V, Heintze S. Meta-Analysis of the Influence of Bonding Parameters on the Clinical Outcome of Tooth-colored Cervical Restorations. J Adhes Dent. 2015 Aug;17(5):391-403. doi: 10.3290/j.jad.a35008.
PubMed 26525003Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.
PubMed 26841969von 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 27377433Young HM, Smith CT, Morton D. Comparative in vitro evaluation of two provisional restorative materials. J Prosthet Dent. 2001 Feb;85(2):129-32. doi: 10.1067/mpr.2001.112797.
PubMed 11208201
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Composition of Temporary Restorative Material on the Retention Rate and Sensitivity for Provisional Direct Restorations in Vital Teeth - Clinical Study Randomized
- ClinicalTrials.gov ID
- NCT03437655
- Acronym / sponsor ID
- 2.358.776
- Conditions
- MTA, Dental Restoration, Temporary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 20 Mar 2018 (estimated)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 19 Feb 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 (retation rate and dental sensibility) of temporary direct restorations in vital teeth. The composition of the temporary direct restoration (based on Zinc-Oxide with Eugenol; and mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.
Detailed description
The confection of temporary direct restoration is still verry commom in dental clinic routine, either by the time required or by biological requirements.The temporary restorations must have sufficient retention and solubility between the consultation intervals to avoid displacement and infiltration; besides being biocompatible to avoid sensitivity. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retention rate and dental sensibility) of temporary direct restoration on vital teeth. The composition of the temporary material (based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate) will be evaluated. Twenty-five participants with at least two vital teeth with the need to confection of direct restoration (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to the temporary material composition (Based on Zinc-Oxide with Eugenol; and based on 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 |
|---|---|---|
| Zinc oxide and eugenol | Active comparator | Procedure: Carie removal, Procedure: Relative isolation, Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol, Procedure: Material insertion on the cavity, Procedure: Finishing the temporary direct restorationTemporary direct restoration with zinc oxide and eugenol. |
| Mineral trioxide aggregate | Active comparator | Procedure: Carie removal, Procedure: Relative isolation, Procedure: Manipulation of the temporary material based on Mineral trioxide aggregate, Procedure: Material insertion on the cavity, Procedure: Finishing the temporary direct restorationTemporary direct restoration with Mineral trioxide aggregate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers; both genres; presence of at least two teeth with indication of direct restoration; good oral hygiene.
Key exclusion criteria (1 listed)
- Dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.
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 |
|---|---|---|
| Carie removalCarie removal with a low speed handpiece | Procedure or surgery | Mineral trioxide aggregate, Zinc oxide and eugenol |
| Relative isolationRelative isolation with cotton and gauze. | Procedure or surgery | Mineral trioxide aggregate, Zinc oxide and eugenol |
| Manipulation of the temporary material based on Zinc Oxide and EugenolManipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations | Procedure or surgery | Zinc oxide and eugenol |
| Manipulation of the temporary material based on Mineral trioxide aggregateManipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations | Procedure or surgery | Mineral trioxide aggregate |
| Material insertion on the cavityMaterial insertion on the cavity according to the manufacturer's recommendations | Procedure or surgery | Mineral trioxide aggregate, Zinc oxide and eugenol |
| Finishing the temporary direct restorationExcess cement removal; Occlusal Adjustment; Finishing and polishing. | Procedure or surgery | Mineral trioxide aggregate, Zinc oxide and eugenol |
Primary outcome
Success rate (retention rate and absence of sensibility) of temporary direct restoration with diferents temporary materials with a 15 days of follow up
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Background: PubMed 23960554Al Jabbari YS, Al-Rasheed A, Smith JW, Iacopino AM. An indirect technique for assuring simplicity and marginal integrity of provisional restorations during full mouth rehabilitation. Saudi Dent J. 2013 Jan;25(1):39-42. doi: 10.1016/j.sdentj.2012.10.003. Epub 2012 Nov 10.
- Background: PubMed 27134427Arora SJ, Arora A, Upadhyaya V, Jain S. Comparative evaluation of marginal leakage of provisional crowns cemented with different temporary luting cements: In vitro study. J Indian Prosthodont Soc. 2016 Jan-Mar;16(1):42-8. doi: 10.4103/0972-4052.164911.
- Background: PubMed 16240963Fonseca RB, Martins LR, Quagliatto PS, Soares CJ. Influence of provisional cements on ultimate bond strength of indirect composite restorations to dentin. J Adhes Dent. 2005 Autumn;7(3):225-30.
- Background: PubMed 21564117Hill EE, Lott J. A clinically focused discussion of luting materials. Aust Dent J. 2011 Jun;56 Suppl 1:67-76. doi: 10.1111/j.1834-7819.2010.01297.x.
- Background: PubMed 2079670Koumjian JH, Nimmo A. Evaluation of fracture resistance of resins used for provisional restorations. J Prosthet Dent. 1990 Dec;64(6):654-7. doi: 10.1016/0022-3913(90)90290-s.
- Background: PubMed 26525003Mahn E, Rousson V, Heintze S. Meta-Analysis of the Influence of Bonding Parameters on the Clinical Outcome of Tooth-colored Cervical Restorations. J Adhes Dent. 2015 Aug;17(5):391-403. doi: 10.3290/j.jad.a35008.
- Background: PubMed 26841969Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.
- 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.
- Background: PubMed 11208201Young HM, Smith CT, Morton D. Comparative in vitro evaluation of two provisional restorative materials. J Prosthet Dent. 2001 Feb;85(2):129-32. doi: 10.1067/mpr.2001.112797.
- 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 Carie removal, Relative isolation and Manipulation of the temporary material based on Zinc Oxide and Eugenol in people with MTA and Dental Restoration, Temporary, 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 1 inclusion and 1 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 7 Mar 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 (retention rate and absence of sensibility) of temporary direct restoration with diferents temporary materials with a 15 days of follow up (time frame: 15 days). 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 NCT03437655, 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 7 Mar 2018.