Plain English Summary
Background and study aims
A dental restoration or filling is a treatment to restore missing parts of the tooth resulting for example from cavities. Postoperative sensitivity is an issue after adhesive restorations. The aim of this study is to assess short- and long-term postoperative sensitivity after dental restorations using six different adhesive treatments.
Who can participate?
Patients aged 18 to 50 with at least one large, deep cavity in the molars or premolars
What does the study involve?
Participants are randomly allocated to one of six different adhesive treatments. Sensitivity is assessed before treatment and after 48 hours, 7 days and 6 months.
What are the possible benefits and risks of participating?
All planned clinical procedures are regularly used in daily practice. Experienced operators were involved in all clinical steps. Therefore, the risks and benefits of participating in this study are those normally present in any clinical procedures. Patients who need further assistance are immediately directed to the corresponding sector in the Dental School.
Where is the study run from?
Federal University of Pará (Brazil)
When is the study starting and how long is it expected to run for?
January 2009 to August 2011
Who is funding the study?
1. National Council for Research Development (Science and Technology Ministry) (Brazil)
2. Federal University of Para (Brazil)
Who is the main contact?
Prof. Mário H. Silva e Souza
honorato@ufpa.br
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 (0)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
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.
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)
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
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
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 (if study stopped)
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 (0)91 3201 7563
mestradodonto@ufpa.br
Sponsor type
University/education
Website
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
Universidade Federal do Pará
Alternative name(s)
Federal University of Pará, UFPA
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Brazil
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
Basic results (scientific)
Publication list