Demineralization, Fissure, Demineralization, Tooth, Non-Cavitated Caries
Conditions
Brief summary
The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.
Detailed description
Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers. The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.
Interventions
OTHERFissure sealing
The materials will be applied to the demineralized fissures as stated in manufacturer's instructions
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with good oral hygiene * Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible
Exclusion criteria
* Medical Problems or Pregnancy * Lack of patient's approval and compliance * Presence of abnormal oral, medical, or mental condition * Known allergy of resin-based materials * Previous placements of sealants or restorations * Bruxism or mal-occlusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 18 months | The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal integrity | 18 months | The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed |
| Caries progression | 18 months | The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline. |
Outcome results
None listed