Postoperative sensitivity evaluation after placement of dental resin restoration when different types of adhesives are used
| ISRCTN | ISRCTN10075349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10075349 |
| Protocol serial number | N/A |
| Sponsor | Federal University of Pará (Brazil) |
| Funders | National Council for Research Development (CNPq) - Science and Technology Ministry (Brazil), Universidade Federal do Pará |
- Submission date
- 27/01/2012
- Registration date
- 14/02/2012
- Last edited
- 09/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Tv. Dom Romualdo de Seixas
156, apt. 501
Belém, PA
66050-110
Brazil
| Phone | +55 (0)91 3229 7337 |
|---|---|
| honorato@ufpa.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center randomised interventional study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Research Ethics Committee of the Federal University of Pará (Brazil), July 2009, ref: 181/08 CEP-ICS-IFPA |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 20/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key 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 |
| Key exclusion criteria | 1. Continuous use of analgesic and anti-inflammatory drugs 2. Patients under orthodontic treatment 3. Using of total or partial removable prosthodontics |
| Date of first enrolment | 10/01/2009 |
| Date of final enrolment | 20/08/2011 |
Locations
Countries of recruitment
- Brazil
Study participating centre
66050-110
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/11/2017: Plain English summary added.
