Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03437629
Other study ID # 2.294.913
Secondary ID
Status Recruiting
Phase N/A
First received February 11, 2018
Last updated February 16, 2018
Start date March 30, 2018
Est. completion date December 30, 2018

Study information

Verified date February 2018
Source Federal University of Uberlandia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy volunteers; both genres; presence of at least two teeth with indication of total crowns; good oral hygiene.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Temporary cement based on Calcium Hydroxide
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 cement
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.

Locations

Country Name City State
Brazil Federal University of Uberlandia Uberlandia Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

Arora 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. — View Citation

da Rosa WLO, Cocco AR, Silva TMD, Mesquita LC, Galarça 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. 2017 May 31. doi: 10.1002/jbm.b.33934. [Epub ahead of print] Review. — View Citation

Hill 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. Review. — View Citation

Malkoç MA, DemIr N, Sengün 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. — View Citation

von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. Review. French, German. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate (retention rate and absence of sensibility) of temporary dental crown cemented with different temporary cement with a 6 months follow up 6 mounths
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06447519 - Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not? N/A
Not yet recruiting NCT03488316 - Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments N/A
Completed NCT04213716 - Comparison of the Efficacy of Calcium Hydroxide With Silver Nanoparticle and Conventional Calcium Hydroxide Intra Canal Medications on Post-Operative Pain in Symptomatic Root Canal Treatment Failure Cases: Phase 2
Active, not recruiting NCT04018716 - Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions N/A
Not yet recruiting NCT05687760 - Effect of Bromelain Versus Calcium Hydroxide as an Intracanal Medication on the Intensity of Postoperative Pain and Bacterial Load Reduction in Necrotic Single Rooted Lower Premolars Early Phase 1
Not yet recruiting NCT05666089 - Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp Early Phase 1