Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions
One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.
- This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
- The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.
- Examination and selection of all patients will be done according to inclusion and exclusion criteria.
- A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
- For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
- For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nourhan K Mohamed, B.D.S
- Telefonnummer: 01003787886
- E-post: nourhankhaled@dentistry.cu.edu.eg
Studiesteder
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Maadi
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Cairo, Maadi, Egypt, 11728
- Nourhan Khaled Mohamed Samir
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Ta kontakt med:
- Nourhan K Mohamed, B.D.S.
- Telefonnummer: 002 01003787886
- E-post: Nourhankhaled@dentistry.cu.edu.eg
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Hovedetterforsker:
- Nourhan K Mohamed, B.D.S
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
a)Inclusion Criteria of participants:
- Male or female gender.
- Only co-operative patients will be approved to participate in the trial.
- Medically free adult patients.
- The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
- Small to moderate cervical lesion.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.
Exclusion Criteria:
a)Exclusion criteria of participants:
- Allergic history concerning methacrylates
- Pregnancy
- Heavy smoking; xerostomia
- Lack of compliance
- Patients with disabilities.
- Patients having systemic diseases or severe medically compromised.
Patients with severe bruxism, clenching, or temporomandibular joint disorders.
b)Exclusion criteria of the teeth:
- Deep defects (close to the pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Pulpitis, non-vital or endodontically treated teeth.
- Sever periodontal affection.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA).
ACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions.
It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives.
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A class v cavity will be prepared after local anesthesia has been given as required.
Rubber dam isolation will be done.
Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces.
Followed by, placement of restorative material according to the randomization sequence.
Finally, restoration finishing and polishing will be done.
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Aktiv komparator: Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan).
Giomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer.
S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries.
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A class v cavity will be prepared after local anesthesia has been given as required.
Rubber dam isolation will be done.
Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces.
Followed by, placement of restorative material according to the randomization sequence.
Finally, restoration finishing and polishing will be done.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Marginal adaptation
Tidsramme: one year
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The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria: Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed |
one year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Marginal Discoloration
Tidsramme: one year
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Clinical evaluation by visual inspection and mirror if needed using modified USPHS criteria. Restorations will be given the score: Alfa if No discoloration Bravo if Non penetrating marginal discoloration which can be polished away Charlie if Discoloration with penetration in pulpal direction. |
one year
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Retention
Tidsramme: one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria : Alfa if restoration is retained and there is no loss of restoration. Charlie if loss of restoration. |
one year
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Secondary caries
Tidsramme: one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if no recurrent caries is detected, charlie if recurrent caries is detected. . |
one year
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surface texture
Tidsramme: one year
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Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if restoration is enamel-like surface Bravo if Surface rougher than enamel, clinically acceptable Charlie if Surface is unacceptably rough. |
one year
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postoperative sensitivity
Tidsramme: one year
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Verbal evaluation by asking the patient. Restorations will be given a score according to modified USPHS criteria: Alfa if not present Bravo if sensitive but diminishing in intensity Charlie if constant sensitivity not diminishing. |
one year
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
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
- cons2021
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
- Full protocol will be published online in Clinicaltrials.gov to avoid repetition, and keep the integrity of the research work.
- Thesis will be discussed and defended in front of a judging committee.
- The study will be published to report the results of this clinical trial.
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- Studieprotokoll
- Statistisk analyseplan (SAP)
- Informert samtykkeskjema (ICF)
- Klinisk studierapport (CSR)
- Analytisk kode
Legemiddel- og utstyrsinformasjon, studiedokumenter
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