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Adhesives procedures in paediatric dentistry

Randomized clinical trial of three adhesives in primary molars restoration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11458186
Enrollment
34
Registered
2019-11-25
Start date
2016-09-01
Completion date
Unknown
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral health, paediatric dentistry Oral Health

Interventions

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-et
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
light-cure for 10 s 2. Clearfil™ SE Protect Bond: Apply primer and leave undisturbed for 20 s
apply bonding agente for 10 s
light-cure for 10 s 3. Prime&Bond® XP: Apply etchant for 15 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

Sponsors

University of Coimbra (Portugal)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Fracture of material and retention measured using the FDI evaluation criteria at baseline, 6 and 12 months

Secondary

MeasureTime frame
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)

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026