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Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT

1. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia)
Stela primer will be applied first after cavity preparation then Stela self-cure composite without curing.
Procedure: Class V Restoration
A class V cavity will be prepared after administering local anesthesia. Rubber dam isolation will be done followed by placement of the restorative material according to the randomization sequence.
Aktiv komparator: Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany)
After total etching of the cavity and bonding, the highly filled flowable composite will be applied in increments then cured.
Procedure: Class V Restoration
A class V cavity will be prepared after administering local anesthesia. Rubber dam isolation will be done followed by placement of the restorative material according to the randomization sequence.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Retention
Tidsramme: 18 Months
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.
18 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Marginal Adaptation
Tidsramme: 18 months
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.
18 months
Marginal Discoloration
Tidsramme: 18 months
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.
18 months
Post-operative Sensitivity
Tidsramme: 18 months
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.
18 months
Recurrent Caries
Tidsramme: 18 months
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.
18 months
Surface Roughness
Tidsramme: 18 months
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.
18 months
Color Match
Tidsramme: 18 months
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.
18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Self-cure Bulk fill Resin

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Carious Cervical Lesions

Kliniske forsøg med Class V Restoration

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uzbekistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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