Condition category
Oral Health
Date applied
27/01/2012
Date assigned
14/02/2012
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mário Honorato Silva e Souza Jr.

ORCID ID

Contact details

Tv. Dom Romualdo de Seixas
156
apt. 501
Belém
PA
66050-110
Brazil
+55 91 3229 7337
honorato@ufpa.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized, split-month clinical study comparing the short and long-term postoperative sensitivity in composite resin restoration using etch-and-rinse and self-etching adhesive systems placed in large and deep class I and II cavities in molars and pre-molars

Acronym

Study hypothesis

This study aims to compare the short and long-term postoperative sensitivity associated with resin restorations of large and deep cavities using the following process:
1. Etch-and-rinse followed by two and three step adhesives (XP Bond, Single Bond, SBMP and All Bond 3+liner)
2. 'Mild’ two-step self-etching adhesives with a hydrophobic coat (All Bond SE+ Liner) and
3. Strong’ two-step self-etching adhesive (Adper SE Plus)

Ethics approval

Research Ethics Committee of the Federal University of Pará (Brazil), July, 2009, ref:181/08 CEP-ICS-IFPA

Study design

Single-center randomised interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Professor Mário Honorato Silva e Souza Jr. (mario-honorato@hotmail.com) to request patient in formation sheet

Condition

Postoperative sensitivity may occur after adhesive restorative procedures. Several reasons could be related to this phenomenon, and the hydrophilic and permeable characteristics of some dental adhesives are one of them, which can be in part controlled by the operator. For instance, the use of a hydrophobic coat after the use the hydrophilic components of dental adhesives may help to control the postoperative discomfort.

Intervention

Cavity preparation and restorative procedures: Class I and II cavities were prepared involving at least half of the distance between cusp tips and the pulpal or axial walls were determined 1 – 1.5mm far from the pulp chamber. Cylindrical carbide burs, selected according to the size of each cavity, were used attached to high- and low-speed hand-pieces.

The adhesive treatments were randomly assigned among patients, tooth types (molars and premolars), and initial tooth condition (decayed or previously restored); the treatments were used according to the manufacturers’ directions. Two previously trained, graduated students prepared and restored the cavities. Eventually, 120 molars and premolars were prepared and restored (one by appointment) using rubber dam isolation and the incremental placement technique. For all six groups, the treated cavities were obliquely layered with A3 Filtek Z-350 nanoparticle composite resin (3M ESPE, St Paul, MN, USA). Each increment of 2 mm thickness was cured for 20 seconds using a LED source, Flash Lite 1410 (Discus Dental, Culver City, CA, USA) and its output energy constantly monitored (± 800mW/cm2).

Materials used in the study
Groups: Materials Manufacturer
1. Adper SBMP/3M ESPE - St Paul, MN, USA
2. Adper Single Bond 2/ 3M ESPE - St Paul, MN, USA
3. XP Bond / Dentsply - Milford - DE, USA
4. All Bond III Bisco Inc, Schaumburg, IL, USA
5. Adper SE Plus / 3M ESPE - St Paul, MN, USA
6. All Bond SE Bisco, Inc. Schaumburg, IL, USA

Pre and postoperative sensitivity evaluation (Initial-T0, 48 hours-T1, seven days-T2, 180 days-T3): This part of the study was conducted blind by one previously trained examiner who did not participate in the restorative procedures and was unable to detect the system used. The initial evaluation (T0) was done immediately before the cavity preparation. Tetrafluorethane spray (Endo-Ice Hygienic, Akron, OH, USA) was applied with a cotton pellet on the middle of the bucal surface for up to 5 seconds. During the tests, the patients were asked to register their discomfort using a visual analogue scale (VAS) according to the following parameters: 0, no discomfort; 1 to 3, light discomfort; 4 to 6, mild discomfort; 7 to 9, intense discomfort (pain); 10, unbearable discomfort (excruciating pain).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Non-parametric Kruskall-Wallis analysis was applied to the verified sensitivity results for all adhesive systems within each evaluation period (independent sample), including T0 (the preoperative evaluation), and no significant differences were detected. According to the p-values observed (p=0,53) at each evaluation period, no significant differences could be found.

Secondary outcome measures

Friedman non-parametric analysis was also applied to the results obtained for each adhesive system at all the evaluation periods (dependent sample), and the p-values (P>0.05) again showed no significant differences

Overall trial start date

10/01/2009

Overall trial end date

20/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 to 50 years and good health
2. The teeth to be restored had to present opposing and adjacent contacts and not exhibit primary or secondary trauma, excessive clenching, or bruxism
3. Low caries risk and good periodontal health were also necessary

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The final distribution of the sample was: 40 teeth restored in male and 80 in female; 24 in premolars and 96 in molars; 46 restorations were made in class I preparations, while 74 in class II

Participant exclusion criteria

1. Continuous use of analgesic and anti-inflammatory drugs
2. Patients under orthodontic treatment
3. Using of total or partial removable prosthodontics

Recruitment start date

10/01/2009

Recruitment end date

20/08/2011

Locations

Countries of recruitment

Brazil

Trial participating centre

Tv. Dom Romualdo de Seixas
Belém, PA
66050-110
Brazil

Sponsor information

Organisation

Federal University of Pará (Brazil)

Sponsor details

School of Dentistry
No. 1
Rua Augusto Corrêa
Campus Universitário do Pará
Faculdade de Odontologia
Programa de Pós-graduação
Belém / PA
66000-000
Brazil
+55 91 3201 7563
mestradodonto@ufpa.br

Sponsor type

University/education

Website

http://www.ufpa.br/posodonto

Funders

Funder type

Government

Funder name

National Council for Research Development (CNPq) - Science and Technology Ministry (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal University of Para (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes