Randomized clinical trial of five adhesive systems in occlusal posterior restorations

ISRCTN	ISRCTN87835631
DOI	https://doi.org/10.1186/ISRCTN87835631
Secondary identifying numbers	N/A

Submission date: 14/07/2014
Registration date: 08/08/2014
Last edited: 08/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Direct adhesive restorations with composite resins (i.e. dental fillings where the dentist places a soft or malleable substance into the tooth and then shapes it before it sets hard) is the treatment of choice for cavities of posterior teeth (the pre-molars and molars found towards the back of the mouth). Nevertheless, the long-term durability of these fillings are hampered as the adhesive (or glue) holding the filling in place weakens over time. This can eventually lead to gaps forming between the filling and the tooth, tooth sensitivity, discolouration of the tooth, further cavities and, in the worse cases, inflammation of the pulp of the teeth. Evaluating the effects of the type of adhesive (adhesive system) used for fillings suffers from a lack of scientific evidence. Here, we aim to test five different adhesive systems as used for treating cavities in posterior teeth.

Who can participate?
Adults with good general and oral health needing restorations (fillings) in their molar or premolar teeth due to cavities

What does the study involve?
Each participant is randomly allocated into one of 5 different groups. Each group are given dental fillings using a different adhesive system. The performance of each of these adhesive systems are then evaluated over the course of a year, including how they look and how well they work.

What are the possible benefits and risks of participating?
The risks to participants are the same as for people treated for dental cavities in clinical practice.

Where is the study run from?
The Coimbra Medical University, School of Dentistry (Portugal)

When did the study start and how long is it expected to run for?
June 2011 to December 2017

Who is funding the study?
University of Coimbra (Portugal)

Who is the main contact?
Alexandra Vinagre
avinagre@fmed.uc.pt

Contact information

Dr Alexandra Vinagre
Scientific

R Adriano Correia de Oliveira, no. 3, R/C
Coimbra
3000-006
Portugal

Phone	+351 912 638 914
Email	vinagrealexandra@gmail.com

Study information

Study design	Single-center randomized interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomized double-blinded controlled clinical trial comparing the behaviour of one three-step etch-and-rinse (Optibond™FL), one two-step etch-and-rinse (Prime&Bond®NT™) and three self-etch adhesives systems; one two-step (Clearfil™SE Bond), one one-step/two-bottle (Xeno®III) and one one-step/one bottle (Xeno®V+) in the restoration of occlusal posterior cavities based on the FDI evaluation criteria and focusing marginal adaptation as the primary outcome.
Study objectives	The null hypothesis (H0) tested was that no significant differences would be detected among the clinical behavior of the five adhesive systems in any of the recall periods.
Ethics approval(s)	Ethics Committee of the Central Hospital of University of Coimbra (Ethics Committee of the Centro Hospitalar e Universitário de Coimbra) (CHUC); ref: HUC 15-09
Health condition(s) or problem(s) studied	Oral health
Intervention	Carious lesions removal was ensured with drilling and dentin spoon excavators. The restorative procedures were performed by one single operator. After application of the respective randomly assigned adhesive system under manufacturer´s directions a microhybrid composite resin (EsthetX® HD; A2) was placed incrementally and light-cured using a LED-curing unit (Bluephase®) in its low intensity mode emitting around 650 mW/cm2. Experimental groups: 1. Optibond® FL: Apply etchant for 15 s; rinse for 15 s; air-dry for 5 s; scrub surface for 15 s with primer; gentle air-blow for 5 s; apply bonding agent; gentle air-blow for 3 s; light-cure for 20 s. 2. Prime&Bond®NT™: Apply etchant for 15 s; rinse for 15 s; air-dry for 5 s; apply adhesive on surface and wait 20 s; gentle air-blow for 5 s; light-cure for 10 s; apply second coat; gentle air-blow for 5 s; light-cure for 10 s. 3. Clearfil™ SE Bond: Apply primer and leave undisturbed for 20 s; gentle air-blow for 5 s; apply bonding agent; gentle air-blow for 5 s; light-cure for 10 s. 4. Xeno® III: Mix liquids A and B for 5 s; apply adhesive on surface and leave undisturbed for 20 s; gentle air-blow for 5 s; light-cure for 10 s. 5. Xeno® V +: Apply adhesive on surface and scrub it in a rubbing motion for 20 s; gentle air-blow for 5 s; light-cure for 10 s.
Intervention type	Other
Primary outcome measure	The FDI evaluation criteria was applied in baseline, 6 months and one year. Marginal adaptation was considered for the primary outcome Score 1: Harmonious outline, no gaps Score 2: Marginal gaps (<150 μm); small marginal fractures Score 3: Marginal gaps (>150 μm and < 250 μm); several marginal fractures Score 4: Marginal gaps > 250 μm or dentin/base exposed; severe marginal fractures Score 5: Restoration lost but in situ; generalized major gaps
Secondary outcome measures	1. The FDI evaluation criteria was applied in baseline, 6 months and one year. 2. Esthetic Properties (surface lustre, marginal and surface staining, anatomical form), 3. Functional Properties (fracture of material and retention, radiographic examination), 4. Biological Properties (postoperative hypersensitivity and tooth vitality; recurrence of caries; tooth integrity; adjacent mucosa)
Overall study start date	24/06/2011
Completion date	24/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	70 participants with carious occlusal lesions were initially selected. 159 restorations (at least 30 for research group) in 54 patients were obtained.
Key inclusion criteria	1. Agreement to participate in the study 2. In good general and oral health 3. Require class I restorations in their molar or premolar teeth due to primary carious lesions 4. In permanent dentition
Key exclusion criteria	Patients with: 1. Systemic diseases, chronic use of anti-inflammatory, analgesic or psychotropic drugs 2. Xerostomy 3. Pregnancy or breastfeeding 4. Periodontal surgery within the previous three months 5. Orthodontic treatment within the previous three months 6. Uncontrolled periodontal disease 7. Bruxism 8. Allergies to specific compounds 9. Uncontrolled oral hygiene 10. Incapacity to undergo rubber dam isolation 11. Inability to attend recall appointments 12. Fewer than 20 teeth Teeth with: 1. Endodontic therapy 2. Function of abutment for fixed or removable prostheses 3. Previous restorations 4. Absence of occlusal contacts with antagonist tooth 5. Fixed or removable prosthetic tooth as antagonist 6. Attrition, abfraction or erosion 7. Fissures or fractures 8. Signs of previous pulp pathology 9. Pathologic mobility 10. Enamel and/or dentin dysplasia 11. Cavities that requires cuspid coverage 12. Cavities involving pulp exposure
Date of first enrolment	24/06/2011
Date of final enrolment	24/12/2017

Locations

Countries of recruitment

Portugal

Study participating centre

R Adriano Correia de Oliveira, no. 3, R/C

Coimbra
3000-006
Portugal

Sponsor information

University of Coimbra (Portugal)
University/education

c/o Alexandra Rosa Rodrigues Vinagre
Faculty of Medicine
Av. Bissaya Barreto, Blocos de Celas
Coimbra
3000-075
Portugal

Phone	+351 912 638 914
Email	avinagre@fmed.uc.pt
"ROR"	https://ror.org/04z8k9a98

Funders

Funder type

University/education

University of Coimbra (Portugal)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan