- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07705633
Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Resin Restorations
Clinical Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Preventive Resin Restorations
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Primary objectives:
Assessment of retention rate and marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria and Simonsen's criteria.
Secondary objectives:
Assessment of stability of results after 3, 6 and 9months.
Studieoversikt
Status
Intervensjon / Behandling
- Enhet: Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid
- Enhet: Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste
- Enhet: Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid
- Enhet: Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
Detaljert beskrivelse
Dental caries is one of the most common intraoral diseases, with serious consequences for both the individual patient and for the public in terms of medical, social, and economic concerns. The individual patient suffers from pain, dysfunction of the oral system, and reduced quality of life.
Caries predominantly attack the occlusal surfaces of premolars and molars during their eruption . On the other hand, smooth surface caries have shown a significant decline, likely a result of increased worldwide access to fluoride . In previous reports, an incomplete post-eruptive maturation , and the presence of narrow and deep fissures were blamed for the increased caries susceptibility of occlusal surfaces . It has been more than 40 years since the pit and fissure sealants were first used clinically. During this time, pit and fissure sealants have been shown to be effective in reducing the risk of occlusal caries . A study aimed to evaluate the effect of the previous application of a casein phosphopeptide-amorphous calcium phosphate paste (MI Paste, MI) and adhesive systems on the bond durability of a fissure sealant. Ninety-eight enamel blocks were obtained from proximal surfaces of erupted third molars.
Anthor study evaluated the effect of treating the enamel with topical fluoride gel prior to acid etching on sealant retention clinically (Part I) and in vitro (Part II). Results showed no statistically significant differences between the test and control groups either clinically or in vitro. It is concluded that topical fluoride application prior to acid etching does not have a deleterious effect on sealant retention .
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Suez, Egypt
- Suez Canal University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Absence of restorations or prior sealants on the teeth under study.
- Patients have simple occlusal spot caries lesions
- Age group 15 - 40 years.
- Ability to return for periodic follow-up
Exclusion Criteria:
- Patients with high DMFS.
- Any fixed orthodontic appliances.
- Smoking habit.
- Pregnant and lactating mothers
- Symptoms of dental pain
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
|
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
|
|
Eksperimentell: Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
|
Group 2 (G2): Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
|
|
Eksperimentell: prevent seal, Itena, North America after treating with Biflourid Group
Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
|
Enhet: Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid
Group 3 (G3): Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
|
|
Eksperimentell: prevent seal, Itena, North America after treating with MI Paste Group
Teeth treated with prevent seal, Itena, North America after treating with MI Paste, GC AmericaC America
|
Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Retention rate of two types of pit and fissure sealants
Tidsramme: After 3 months, 6 months and 9 months
|
Assessment of retention rate of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
|
After 3 months, 6 months and 9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
marginal integrity assessments
Tidsramme: After 3 months, 6 months and 9 months.
|
Assessment of marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
|
After 3 months, 6 months and 9 months.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 376/2021
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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