Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
2 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Geschat)
50
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Abdelrahman Hamza, Bachelor of Science
- Telefoonnummer: +20 1063330630
- E-mail: abdelrahmanh.hamza@dentistry.cu.edu.eg
Studie Locaties
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Cairo, Egypte
- Faculty of Dentistry, Cairo University
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Contact:
- Abdelrahman Hamza, Bachelor of Science
- Telefoonnummer: +20 1063330630
- E-mail: abdelrahmanh.hamza@dentistry.cu.edu.eg
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Retention
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Marginal Adaptation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 februari 2027
Studie voltooiing (Geschat)
1 april 2027
Studieregistratiedata
Eerst ingediend
1 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 mei 2026
Eerst geplaatst (Werkelijk)
8 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
2 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Self-cure Bulk fill Resin
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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