Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03214445
Other study ID # 2012/10
Secondary ID
Status Completed
Phase N/A
First received May 18, 2017
Last updated July 10, 2017
Start date March 1, 2015
Est. completion date May 1, 2017

Study information

Verified date July 2017
Source University of Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention , and then assessed by the FDI criteria for clinical performance and longevity of restorations


Description:

This is a prospective, double-blind randomized clinical trial under the recommendations of CONSORT. The statistical unit was considered the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention.

Inclusion criteria:

- Age 18 or older

- High risk of caries.

- With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.

Exclusion criteria:

- Patients with the impossibility of mouth opening or dental treatments.

- Patients with allergies to any of the materials used.

- The presence of adjacent to the restoration or secondary caries.

- Patients with prior sealed of their restorations.

The volunteers were informed of the objectives and risks of treatment, as well as the freedom to leave the study. It explained in detail the clinical procedure which was submitted and proceeded to sign the informed consent according to the rules of the Ethics Committee of the Faculty of Dentistry of the University of Chile.

Then were assigned the sample within 3 groups of randomly with software Eclipse SDK 4.2.1: (1) sealing with fluid composite resin restorations with nano filled and universal adhesive, (2) sealant adhesive based on resin composite resin with universal adhesive and (3) group control or untreated.

Initial examination Examination of patients was performed independently by two calibrated evaluators, in case of disagreement operators were consulted with a third operator, this in a clinical field well lit, with the tooth surface clean with brush of prophylaxis and water, for the clinical examination was used to mirror No 5 (Hu-Friedy Mfg. Co. Inc., Chicago, IL, USA), probe of caries straight with active diameter of 150 μm portion (Deppeler, Swiss Dental) and caries probe straight with active portion of diameter 250 μm (Deppeler, Swiss Dental), both indicated by the FDI. For an optimal value in the parameter of marginal adaptation, the gap should be a size less than or equal to the diameter of the active portion of the probes.

Procedure

Once selected patients and their restorations, were polished using aluminum oxide disks with complete series (Sof-Lex. 3M ESPE) and polished tips (Diacomp, Brasseler).

Each restoration to seal received an identification code, which was awarded randomly belong to an experimental group, as described previously. The tabulation and data of each treatment were conducted in the program Microsoft Excel 2011.

Software Cariogram was used to assess the parameters for the analysis of risk cariogenic: the experience of caries, diseases related, content diet, the frequency of diet, the quantity of plaque, fluor exposition , salivary secretion, capacity buffer and clinical judgment.

Treatment and clinical intervention groups

Group 1::Sealed with fluid resin composite with nanofiller.

Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the protocol of conditionate surface with orthophosphoric acid 35%, for 15 seconds, washed ( abundant water by 30 s) and dried with compressed air from the syringe for 15 s. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, dried for 5 seconds for evaporation of the solvent remaining and photopolymerized for 10 seconds, using light curing (2500 Curing light, 3M ESPE).

Applied in marginal defects of nanoparticle flowable composite resin (Filtek Flow Z350XT, 3M ESPE) with instrument for cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), it is polymerized for 20 seconds (2500 Curing light, 3 M ESPE).

The occlusal checked was controlled with paper articulate with 200 microns of width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with a stone No. 3 high speed (SSWhite, USA).

Group 2: Sealed with sealant based on resin. Once cleaned the restoration with prophylaxis hard brush and water, at low speed. The procedure was performed under absolute isolation with a rubber dam and using ejector to remove saliva and excess water. Following the same Protocol of conditioning, this was done with orthophosphoric acid 35%, for 15 seconds, wash by 30 seconds and dried with compressed air from the syringe for 15 seconds. Then proceeded with the application of adhesive (Single Bond Universal, 3M ESPE) with brush (Microbrush International, Grafton, USA) and friction against the surface for 20 seconds, flow of air for 5 seconds for evaporation of the solvent remaining and polymerizing for 10 seconds, using light curing (2500 Curing light, 3M ESPE).

Applied in marginal defects sealant of pits and fissures based on composite resin (Clinpro Sealant, 3 M ESPE) instrument of cement application of calcium hydroxide (PICH, Hu Friedy Mfg. Co Inc., Chicago, IL, USA), polymerized for 20 seconds (2500 Curing light, 3 M ESPE).

The occlusal checked was controlled with paper articulate 200 microns width (Bausch Articulating Papers, Inc., USA), occlusal adjustments and wear were carried out with stone No. 3 high speed (SSWhite, USA).

Group 3: control. The restorations were evaluated without treatment about defective restoration that was considered clinically acceptable.

Evaluation of treatments

Clinical assessments were made at 6 and 12 months in the parameters marginal adaptation, marginal staining and secondary caries and sealant retention.

Examination was performed independently by two calibrated operators, in case of disagreement were consulted with a third operator, this in a clinical field well lit, with the clean tooth surface with brush of prophylaxis and water, for the clinical examination was used the same methodology and instrumentation that examination.

Analysis of the clinical performance of the treatment groups

To evaluate the behavior of these treatments, after 6 and 12 months, was made the comparison versus baseline, whose valuation assigned to the subsequent application of seal evaluation was 1 (FDI), with the current state of the restoration.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 1, 2017
Est. primary completion date December 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or older

- High risk of caries.

- With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria.

Exclusion Criteria:

- Patients with impossibility of mouth opening or dental treatments.

- Patients with allergies to any of the materials used.

- Presence of adjacent to the restoration or secondary caries.

- Patients with prior sealed of their restorations.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sealing margins with flow composite
Seal the margin of restoration with Composite flow with nanofiller
Sealing margins with seal
Seal the margin of restoration with sealant without filler

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Chile

References & Publications (1)

Fernández E, Martin J, Vildósola P, Estay J, de Oliveira Júnior OB, Gordan V, Mjor I, Gonzalez J, Loguercio AD, Moncada G. Sealing composite with defective margins, good care or over treatment? Results of a 10-year clinical trial. Oper Dent. 2015 Mar-Apr;40(2):144-52. doi: 10.2341/14-143-C. Epub 2014 Dec 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Marginal adaptation ( mm of bridge between tooth and restorations ) 6 month
Primary Marginal staining, ( + >50% diameter / - <50% diameter) 4 years
Primary Retention of seal ( is present + / was loose -) Loss of restoration 4 years
See also
  Status Clinical Trial Phase
Completed NCT04127929 - Investigation of Glass Carbomer Performance N/A
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Active, not recruiting NCT04475679 - Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy N/A
Completed NCT05438381 - Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars N/A
Not yet recruiting NCT03037814 - Clinical Performance of Restorative Materials in Primary Teeth N/A
Active, not recruiting NCT05202665 - Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion N/A
Terminated NCT01147835 - Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers N/A
Not yet recruiting NCT04033263 - Maintaining Oral Health With Bio-products N/A
Enrolling by invitation NCT04438252 - Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions N/A
Not yet recruiting NCT03609034 - Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02473107 - Impact of Detecting Initial and Active Caries Lesions in Primary Teeth N/A
Active, not recruiting NCT02537184 - Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children N/A
Completed NCT01950546 - Nanosilver Fluoride to Prevent Dental Biofilms Growth Phase 1
Recruiting NCT02734420 - Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial Phase 1
Completed NCT02020681 - Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions N/A
Completed NCT02426619 - Arresting Active Dental Caries in Preschool Children by Topical Fluorides Phase 2/Phase 3
Completed NCT02234609 - Effectiveness of Modified Class IV Atraumatic Restorative Treatment N/A
Completed NCT01268605 - Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial Phase 3