MTANCT03437629
Influences of Different Temporary Cement on Retention Rate of Temporary Crowns
A study testing Temporary cement based on Calcium Hydroxide and MTA temporary cement in people with MTA and Calcium Hydroxide, 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, split-mouth, evaluate the success rate (retention rate and dental sensibility) of temporary dental crown cemented on vital teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MTA, Calcium Hydroxide, Dental Crown
- What is being tested?
- Temporary cement based on Calcium Hydroxide and MTA temporary cement
- 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
- 30 Mar 2018to 30 Dec 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 total crowns; 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, 1 recruiting
- Recruiting
Federal University of Uberlandia
Uberlândia, Minas Gerais, 381440617
Paulo V Soares, DDS, MS, PHD, +55 34 991615642, paulovsoares@yahoo.com.br
Alexandre C Machado, DDS, MS, +55 34 99133 5399, alexandrecoelhomachado@gmail.com
About this study
Official title: Influences of Different Temporary Cement on Retention Rate and Dental Sensitivity of Temporary Crown on Vital Teeth - Randomized Clinical Trial
The aim of this study is through a randomized clinical trial, double blind, split-mouth, evaluate the success rate (retention rate and dental sensibility) of temporary dental crown cemented on vital teeth. The composition of the 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 confecction of temporary prosthesis is a fundamental step in the prosthetic process of definitive total crowns. The temporary cementation should provide sufficient retention between the intervals of the consultations, be biocompatible and not present high solubility. 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 dental crown cemented on vital teeth. The composition of the cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two vital teeth with the need to confection of definitive total crowns (each participant) will be selected who present. The teeth will be randomly divided into 2 different groups according to the temporary cement composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis
- Conditions
- MTA, Calcium Hydroxide, Dental Crown
- Being tested
- Temporary cement based on Calcium Hydroxide, MTA temporary cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary cement based on Calcium HydroxideProcedure or surgery
Confection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Calcium Hydroxide; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment.
MTA temporary cementProcedure or surgery
Confection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Mineral trioxide aggregate; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide temporary cement | Active comparator | Cementation of a temporary crown with cement based on calcium hydroxide. Receives: Procedure: Temporary cement based on Calcium Hydroxide |
| MTA temporary cement | Active comparator | Cementation of a temporary crown with cement based on Mineral trioxide aggregate . Receives: Procedure: MTA temporary cement |
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 dental crown cemented with different temporary cement with a 6 months follow up
Measured: 6 mounths
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 start30 Mar 2018 (estimated)
- Primary completion30 Mar 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- NCT03437629
- Sponsor's protocol ID
- 2.294.913
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- 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 27134427da 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 28561919Hill 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 21564117Malkoc 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 25722833von 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Different Temporary Cement on Retention Rate and Dental Sensitivity of Temporary Crown on Vital Teeth - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03437629
- Acronym / sponsor ID
- 2.294.913
- Conditions
- MTA, Calcium Hydroxide, Dental Crown
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 30 Mar 2018 (estimated)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 Dec 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, split-mouth, evaluate the success rate (retention rate and dental sensibility) of temporary dental crown cemented on vital teeth. The composition of the 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
The confecction of temporary prosthesis is a fundamental step in the prosthetic process of definitive total crowns. The temporary cementation should provide sufficient retention between the intervals of the consultations, be biocompatible and not present high solubility. 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 dental crown cemented on vital teeth. The composition of the cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two vital teeth with the need to confection of definitive total crowns (each participant) will be selected who present. The teeth will be randomly divided into 2 different groups according to the temporary cement composition (Based on calcium hydroxide; 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 |
|---|---|---|
| Calcium Hydroxide temporary cement | Active comparator | Procedure: Temporary cement based on Calcium HydroxideCementation of a temporary crown with cement based on calcium hydroxide. |
| MTA temporary cement | Active comparator | Procedure: MTA temporary cementCementation of a temporary crown with cement based on 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 total crowns; 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 |
|---|---|---|
| Temporary cement based on Calcium HydroxideConfection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Calcium Hydroxide; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment. | Procedure or surgery | Calcium Hydroxide temporary cement |
| MTA temporary cementConfection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Mineral trioxide aggregate; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment. | Procedure or surgery | MTA temporary cement |
Primary outcome
Success rate (retention rate and absence of sensibility) of temporary dental crown cemented with different temporary cement with a 6 months follow up
Time frame: 6 mounths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 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 28561919da 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.
- 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 25722833Malkoc 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.
- 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
Related trials for MTA
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer
Not yet recruitingPhase 3
Evaluation of the Effect of Time of Administration on the Activity on First Line of Pembrolizumab in Association With Carboplatin-pemetrexed in Metastatic Non-squamous Lung Cancer. A Randomised Multicenter Phase III Trial
Metastasic NSCLC
RecruitingPhase 3
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary cement based on Calcium Hydroxide and MTA temporary cement in people with MTA and Calcium Hydroxide, 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 19 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (retention rate and absence of sensibility) of temporary dental crown cemented with different temporary cement with a 6 months follow up (time frame: 6 mounths). 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 NCT03437629, which also lists 6 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 19 Feb 2018.