Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
2. juli 2026 oppdatert av: Abdelrahman Hamza Halim Hamza, Cairo University
Clinical Performance of a Self-Cure Composite System Versus a Highly Filled Flowable Composite System in Carious Cervical Lesions: A Randomized 18 Months Clinical Trial
The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Examination and selection of patients will be done according to the inclusion and exclusion criteria. A class V cavity will be prepared after local anesthesia has been given. Followed by the placement of the restorative material according to the randomization sequence.
For the intervention: the primer will be applied first followed by filling of the cavity using self cure composite (Stella Automix or Stela Capsule, SDI Ltd, Australia). For the control group: etching of the cavity (Kulzer Gluma Etch, Kulzer GmbH, Germany) will be done followed by rinsing, drying, applying the bonding agent (Solobond M, Voco GmbH, Germany), curing, and lastly, applying the highly filled flowable composite (Polofil NHT flow, Voco Gmbh, Germany) and curing.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Abdelrahman Hamza, Bachelor of Science
- Telefonnummer: +20 1063330630
- E-post: abdelrahmanh.hamza@dentistry.cu.edu.eg
Studiesteder
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Cairo, Egypt
- Faculty of Dentistry, Cairo University
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Ta kontakt med:
- Abdelrahman Hamza, Bachelor of Science
- Telefonnummer: +20 1063330630
- E-post: abdelrahmanh.hamza@dentistry.cu.edu.eg
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Patient-related Criteria:
A) Inclusion Criteria:
- Patients consulting in the outpatient clinic with cervical carious lesion.
- Age between 21-45 years.
- Males and females.
B) Exclusion Criteria:
- Systemic disease or severe medical complication.
- Allergy to any of the restorative materials.
- Pregnancy.
- Disabilities.
- Heavy smoking; xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits.
Tooth-related Criteria:
A) Inclusion Criteria:
- Small to moderate class V carious lesion.
- Teeth are vital with no signs of irreversible pulpitis.
- Caries cervical margins above the CEJ.
- Well-formed and fully erupted in normal functional occlusion with natural antagonist.
B) Exclusion Criteria:
- Deciduous teeth; as the study is targeting only permanent teeth.
- Deep carious defects (close to the pulp, less than 1 mm distance).
- Tooth hypersensitivity.
- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- Heavy occlusion and occlusal contacts or history of bruxism.
- Endodontically treated teeth.
- Periapical pathology or signs of pulpal pathology.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia)
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A class V cavity with 1 mm occlusal bevel will be prepared after administrating local anesthesia followed by rubber dam isolation.
Stela Primer (SDI Limited, Australia.)
will be applied for 5 seconds on the cavity and the margins, then it will be gently dried with air for 2-3 seconds without light curing.
The self-cure bulk fill resin composite (Stela Automix or Stela Capsule, SDI Limited, Australia) will be applied then sculpted using a gold-plated composite applicator (Lascod, Italy).
Full polymerization will take place after 4 minutes.
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Aktiv komparator: Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany)
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A class V cavity with 1 mm occlusal bevel will be prepared after administering local anesthesia.
Rubber dam isolation will be done, , etching of the enamel (20-30 seconds) and dentin (15 seconds) using a 35% phosphoric acid etch (Kulzer Gluma Etch, Kulzer GmbH, Germany), then rinsing for 20 seconds followed by controlled drying of the cavity till it's slightly moist.
Application of the bonding agent (Solobond M, Voco GmbH, Germany) using a disposable brush and leaving it to act for 30 seconds then an air jet will be used to disperse the bonding agent.
Curing for 20 seconds will be done using a LED light curing unit with curing intensity 1200-3000 mw/cm2 (CuringPen-E, Changzhou Sifary Medical Technology Co., Ltd, China).
Flowable composite (Polofil NHT flow, Voco GmbH, Germany) will be placed, adapted by gold plated applicator then light polymerized for 20 seconds using light emitting diode (LED) light curing unit.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Retention
Tidsramme: 18 Months
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The restoration will be clinically assessed according to the modified USPHS criteria.
Restoration will be given Alpha score when there is no loss of restoration.
It will be given a Charlie score when there is loss of restoration and need for replacement.
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18 Months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Marginal Adaptation
Tidsramme: 18 months
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The restoration will be clinically assessed according to the modified USPHS criteria.
It will be give an Alpha score when the restoration is closely adapted with no detectable margin.
It will be given a Bravo score when there is a detectable marginal discrepancy, but it still clinically acceptable.
It will be given a Charlie score when there is a marginal crevice that is clinically unacceptable.
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18 months
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Marginal Discoloration
Tidsramme: 18 months
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The restoration will be clinically assessed according to the modified USPHS criteria.
It will be given an Alpha score when there is no discoloration between the tooth and the restoration.
It will be given a Bravo score when there is superficial discoloration which can be polished away.
It will be give a Charlie score when the discoloration has penetrated beyond the margin in pulpal direction.
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18 months
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Post-operative Sensitivity
Tidsramme: 18 months
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The restoration will be clinically assessed according to the modified USPHS criteria.
It will be give an Alpha score when there is no post-operative sensitivity and a Charlie score when there is post-operative sensitivity.
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18 months
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Recurrent Caries
Tidsramme: 18 months
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The restoration will be clinically assessed according to the modified USPHS criteria.
It will be given an Alpha score when there is no detectable recurrent caries and a Charlie score when recurrent caries is detected.
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18 months
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Surface Roughness
Tidsramme: 18 months
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The restoration will be clinically assessed according to the modified USPHS criteria.
It will be given an Alpha score when there is no surface defect.
It will be given a bravo score when there is minimal surface defect.
It will be given a charlie score when there is a severe surface defect.
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18 months
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Color Match
Tidsramme: 18 months
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The restoration will be clinically assessed according to the modified USPHS criteria.
It will be given an Alpha score when the restoration matches the color of the tooth.
It will be give a Bravo score when there is an acceptable mismatch.
It will be given a Charlie score when there is an unacceptable mismatch.
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18 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. februar 2027
Studiet fullført (Antatt)
1. april 2027
Datoer for studieregistrering
Først innsendt
1. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. mai 2026
Først lagt ut (Faktiske)
8. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Self-cure Bulk fill Resin
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