Home » Trials » SLCTR/2022/017
Effectiveness of immediate dentin sealing in the clinical performance of indirect restorations. Clinical Trial
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SLCTR Registration Number
SLCTR/2022/017
Date of Registration
The date of last modification
Jul 01, 2022
Scientific Title of Trial
Effectiveness of immediate dentin sealing in the clinical performance of indirect restorations. Clinical Trial
Public Title of Trial
Comparison of the clinical performance of immediate dentin sealant versus delayed dentin sealant in the cementation of adhesive partial restorations: Randomized Controlled Clinical Trial
Disease or Health Condition(s) Studied
Dental Caries
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1276-4585
Any other number(s) assigned to the trial and issuing authority
058/2022 /2022: Mexico
What is the research question being addressed?
Is the clinical performance of immediate dentin sealant better than using delayed dentin sealant in the cementation of adhesive partial restorations?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Dentistry Academic Area of Dentistry, Health Sciences Institute, Autonomous University of Hidalgo State. Pachuca, Mexico.
Sampling method: Convenience sampling
Intervention: Conventional indirect restoration involves a series of complicated procedural steps. These restorations are laboratory fabricated and require at least two appointments: One for preparation and impression/model fabrications, and one for luting
Control group (delayed dentin sealing): In the first appointment, an impression is immediately taken after tooth preparation, followed by luting a temporary restoration. In the second appointment, once the indirect restoration is fabricated, the temporary restoration is removed, then a bonding agent is applied to the dental substrate; next, for the adhesive luting procedure, a resin luting agent is applied
Intervention Group (immediate dentin sealing): in this procedure, an adhesive system is applied directly to the fresh cut dentin preceding the placement of the provisional phase. Immediate Dentin Sealing demands hybridization of the freshly dentinal surface closely after preparing the tooth and before the luting processes.
Inclusion criteria
• Men and women * Over the age of 18 * Patients who have at least one tooth with extensive caries involving at least two tooth surfaces. • That they provide contact details for follow-up. • That the dental organ to intervene present vitality. • Absence of periodontal disease. • That has no symptoms to percussion tests. • Patients with type II cavities at least 3mm deep
Exclusion criteria
• That the patient presents root canal treatment in the dental organ to be intervened. • That presents exposure of the pulp chamber partially or totally during the procedure. • That during the radiographic evaluation there is some type of anomaly that indicates suspicion of pulpal injury.
Primary outcome(s)
|
1.
1.To evaluate of postoperative sensitivity after cementation of the restoration in the group with dentin sealant and without immediate dentin sealant using a visual analog scale |
[ One day after cementation restauration ] |
Secondary outcome(s)
|
1.
To evaluate the state of the cemented restoration after the procedure in the group with and without dentin sealing using the Veneres evaluation criteria six month after intervention(Gresnigt MM, Kalk W, Ozcan M. Randomized clinical trial of indirect resin composite and ceramic veneers: up to 3-year follow-up. J Adhes Dent. 2013 Apr;15(2):181-90. doi: 10.3290/j.jad.a28883. PMID: 23534025) |
[ Six month after the intervention ] |
Target number/sample size
60 (30 in each group)
Countries of recruitment
Mexico
Anticipated start date
2022-07-15
Anticipated end date
2024-04-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Universidad Autónoma del Estado de Hidalgo
Regulatory approvals
Not relevant
Status
Approved
Date of Approval
2022-03-18
Approval number
058/2022 /2022
Details of Ethics Review Committee
| Name: | Committee of Ethics and Research, Department of Research, , School of Health Sciences, Universidad Autónoma del Estado de Hidalgo, Mexico |
| Institutional Address: | Circuito Ex Hacienda La Concepcion S/N Carretera Tlaxiaca, Hidalgo. Mexico. C.P 421 |
| Telephone: | 52(771)71 720-00 Ext. 5104 |
| Email: | investigacion_icsa@uaeh.edu.mx |
Contact person for Scientific Queries/Principal Investigator
Miguel Angel Fernández Barrera
Professor
Circuito Ex Hacienda La Concepcion S/N Carretera Tlaxiaca, Hidalgo. Mexico. C.P 421
52(771)71 720-00 Ext. 5104
+52 7711276265
mafba.mafb@gmail.com
Contact Person for Public Queries
Miguel Angel Fernández Barrera
Professor
Circuito Ex Hacienda La Concepcion S/N Carretera Tlaxiaca, Hidalgo. Mexico. C.P 421
52(771)71 720-00 Ext. 5104
+52 7711276265
mafba.mafb@gmail.com
Primary study sponsor/organization
Universidad Autónoma del Estado de Hidalgo
Circuito Ex Hacienda La Concepción S/N Carretera Pachuca Actopan, San Agustín Tlaxiaca, Hidalgo
(771) 71 720 00 Ext. 4301
mafba.mafb@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data collected during the trial, after de-identification will be shared. Study protocol, statistical analysis plan will also be available. Data will be available immediately following publication, no end date. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose for individual participant data meta analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available at the University data warehouse but without investigator support other than deposited meta-data. Information regarding submitting proposals and accessing data may be found at (mafba.mafb@gmail.com)
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
