Adhesives procedures in paediatric dentistry
| ISRCTN | ISRCTN11458186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11458186 |
- Submission date
- 22/10/2019
- Registration date
- 25/11/2019
- Last edited
- 17/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
In Pediatric Dentistry there is a growing interest in adhesive systems that allow consistent adhesion to enamel and dentin with a shorter working time possible. Self-etch adhesive systems are potential and particularly interesting for clinical practice with children as they can decrease the time of restorative protocol and/or the complexity of the technical steps.
During long, restorative treatments recommended for temporary and permanent teeth were similar because it was thought there were no significant differences both in composition and microstructure of the tissues that form these two types of teeth. However, nowadays these divergences are properly described in the literature and include several differences such as the amount of intertubular dentin, density of tubules and amount of microtubules transverse to dentinal tubules; primary dentin, according to some authors, also features a lower concentration of phosphate and calcium ions. All these facts might hinder or individualize the adhesion process in deciduous dentin and enamel, making it crucial to study and develop specific adhesive restorative strategies equally effective for temporary dentition.
Although all the materials in study are already legally approved for clinical use, does not exist, so far, any publications in indexed journal that embraces an assessment regarding prospective clinic efficacy of different types of adhesives in temporary teeth. Following a line of investigation already initiated that includes in vitro studies, it seems pertinent to analyse, compare and quantify the results obtained with an in vivo study.
Who can participate?
Patients aged 4-8 years with molar lesions
What does the study involve?
Our research group performed a prospective randomized clinical trial to evaluate the clinical effectiveness of three adhesive systems: a self-etch of two steps with selective enamel etching, a self-etch of one step, and an etch-and-rinse system in deciduous dentition at 6, and 12 months.
Participants had standard treatment of tooth lesions. Restoration of the tooth was carried out using one of three different adhesives assigned randomly to participants
What are the possible benefits and risks of participating?
The procedures allows that the existing caries injury is treated with materials that are already legally approved for clinical use, avoiding biological, functional and structural complications that could advise from the non-treatment. There is no increased risk with this clinical procedure since the restorative protocol used is the conventionally recommended and the teeth to be covered need treatment effectively
Where is the study run from?
School of Dentistry, Faculty of Medicine of the University of Coimbra, Portugal
When is the study starting and how long is it expected to run for?
September 2016 to August 2018
Who is funding the study?
University of Coimbra, Portugal
Who is the main contact?
Dr Ana Dani Soares
ana.dani.soares@gmail.com
Contact information
Scientific
Área de Medicina Dentária
Faculdade de Medicina
Universidade de Coimbra.
Av. Bissaya Barreto
Blocos de Celas
Coimbra
3000-075 Coimbra
Portugal
 ORCID ID |
0000-0002-6841-3990 |
|---|---|
| Phone | +351 239 484183 |
| ana.dani.soares@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 | No participant information sheet available |
| Scientific title | Randomized clinical trial of three adhesives in primary molars restoration |
| Study objectives | Significant differences would be detected among the clinical behavior of the three adhesive systems in primary molars in any of the recall periods (6 and 12 months) |
| Ethics approval(s) | 1. Approved 30/09/2015, Ethics Committee of the Central Hospital of University of Coimbra (Ethics Committee of the Centro Hospitalar e Universitário de Coimbra) (CHUC) (Praceta Prof. Mota Pinto, 3000-075 Coimbra, Portugal; +351 239400400; gai@huc.min-saude.pt), ref: CHUC 056-15 2. Approved 25/03/2015, Ethics Committee of Faculty of Medicine, University of Coimbra (FMUC) (Unidade Central, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, Celas, 3000-354 COIMBRA – PORTUGAL;+351 239857700; comissaoetica@fmed.uc.pt), ref: CE-010/2015 |
| Health condition(s) or problem(s) studied | Oral health, paediatric dentistry |
| Intervention | Our research group performed a prospective randomized clinical trial to evaluate the clinical effectiveness of three adhesive systems: a self-etch of two steps with selective enamel etching, a self-etch of one step, and an etch-and-rinse system in deciduous dentition at 6, and 12 months. 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 composite resin (Ceram.X® Universal; A3) was placed incrementally and light-cured using a LED-curing unit (S.P.E.C.®3) Experimental groups: 1. Clearfil™ S3 Bond : Apply adhesive on surface and scrub it in a rubbing motion for 10 s; gentle air-blow for 5 s; light-cure for 10 s 2. Clearfil™ SE Protect Bond: Apply primer and leave undisturbed for 20 s; gentle air-blow for 5 s; apply bonding agente for 10 s; gentle air-blow for 5 s; light-cure for 10 s 3. Prime&Bond® XP: 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 20 s One single experienced and calibrated operator performed all restorative treatments. In all cases was made a prior polishing of the tooth with a prophylactic brush and water to remove plaque and salivary film remaining. Was then administered local anesthesia. Isolation with rubber-dam was done in all procedures. After cavity preparation a collaborator selected randomly the adhesive system (Prime&Bond active TM, ClearfilTM S3 Bond Plus and ClearfilTM SE Protect), which was applied according to the manufacturer's instructions. The restorations were made with a light-cured nano hybrid composite resin (Ceram.X®) and with the support of a sectional matrix system (Palodent®Plus) and, applied according to the incremental technique and the manufacturer's indications. Finishing and polishing were made using diamond drills, cups and brushes (Enhance® and Ceram.X® gloss). All the restorations were recorded using digital photography and analyzed by two blinded calibrated evaluators (calibration model approved by the FDI – World Dental Federation) in two different moments: on the day of execution and after 6 months. The evaluation was based on aesthetic, functional and biological factors adapted to the specificity of this study. Randomisation was performed using a sealed envelope technique |
| Intervention type | Other |
| Primary outcome measure | Fracture of material and retention measured using the FDI evaluation criteria at baseline, 6 and 12 months |
| Secondary outcome measures | Using FDI evaluation criteria applied at baseline, 6 and 12 months: 1. Esthetic Properties (surface lustre, marginal and surface staining, anatomical form) 2. Biological Properties (postoperative hypersensitivity and tooth vitality; recurrence of caries; tooth integrity; adjacent mucosa) |
| Overall study start date | 01/09/2016 |
| Completion date | 31/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 34 participants with carious proximal lesions were initially selected. 101 restorations (at least 33 for research group) in 34 patients were obtained |
| Total final enrolment | 34 |
| Key inclusion criteria | 1. Deciduous molars with caries lesion on the interproximal face with dentinal involvement, without pulp pathology 2. Caries lesion with margins entirely in enamel 3. Presence of antagonistic tooth with occlusal contact 4. Collaborating patients 5. Aged 4 to 8 years 6. Available for compliance with control appointments |
| Key exclusion criteria | 1. Teeth with structural changes (such as hypoplasia or hypomineralization) 2. Teeth with mobility 3. Systemic pathology that conditioned oral health (oncological pathology, asthmatics, diabetics, etc.) 4. Taking medicines with recognized oral repercussions 5. Inability of the child and/or parents to ensure proper oral hygiene 6. Presence of periodontitis and/or gingivitis 7. Impossibility of adequate isolation 8. Refusal by parents/legal guardians and/or child (if applicable) to sign informed consent |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 23/12/2016 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Blocos de Celas
Coimbra
3000-075
Portugal
Sponsor information
University/education
c/o Ana Daniela dos Santos Soares
Faculty of Medicine
Av. Bissaya Barreto
Blocos de Celas
Coimbra
3000-075
Portugal
| Phone | +351 964313543 |
|---|---|
| ana.dani.soares@gmail.com | |
"ROR" |
https://ror.org/04z8k9a98 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | primary outcome results | 13/09/2022 | 17/10/2022 | Yes | No |
Editorial Notes
17/10/2022: Publication reference added
04/11/2019: Trial’s existence confirmed by Ethics Committee of the Central Hospital of University of Coimbra
