Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars (GIOMER-RCT)
24. april 2026 opdateret af: Nadine elsayed Elshayal, Cairo University
Clinical Evaluation of Injectable Bioactive Composites Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Tria
This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using revised FDI criteria.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dental caries remains the most prevalent chronic disease in children. The choice of restorative material for primary teeth significantly impacts treatment outcomes and longevity. This study compares two fluoride-releasing restorative materials in proximal cavities of primary molars.
Eligible children aged 3-8 years with ICDAS 3 or 4 proximal carious lesions in primary molars will be randomly allocated into two equal groups (24 teeth each):
Group I (Intervention): Restoration with injectable bioactive giomer (Beautifil Flow Plus X F00, Shofu) using BeautiBond Xtreme adhesive Group II (Control): Restoration with Resin Modified Glass Ionomer (RMGI)
Restorations will be clinically evaluated at baseline, 3, 6, and 12 months using revised FDI criteria assessing biological properties (secondary caries, sensitivity, tooth integrity), functional properties (marginal adaptation, proximal contact, occlusal wear, fracture/retention), and aesthetic properties.
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
- Navn: Nadine Elsayed Ahmed Elshayal
- Telefonnummer: 01069995861
- E-mail: nadine.elshayal@dentistry.cu.edu.eg
Undersøgelse Kontakt Backup
- Navn: Dina Mohamed
- E-mail: dina.ezz@dentistry.cu.edu.eg
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
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Children aged 3-8 years of both genders
- Cooperative behavior manageable by operators
- Willing to sign informed consent
- Accepts the follow-up period
- Moderate to low caries risk according to Cariogram application
- Posterior primary molar with proximal carious lesion (ICDAS 3 or 4) with no signs or symptoms of pulpal involvement
- Radiographically extending to outer 1/3 of dentin
Exclusion Criteria:
- Allergy to any restorative materials
- Patients undergoing orthodontic treatment with fixed appliances
- Patients with debilitating systemic diseases
- Children with special needs
- Teeth with previous restorations
- Periapical radiolucencies or sensitivity to percussion
- Mobile teeth
- External or internal resorption
- Cervical carious lesions
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: RMGIC
cavity restorations in primary molars using a resin-modified glass ionomer cement.
Following standard cavity preparation, the RMGI material will be placed according to the manufacturer's instructions.
Clinical performance will be evaluated over the follow-up period in terms of restoration retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall clinical success.
|
genopbygning af proximale kaviteter i primære molarer ved hjælp af et injicerbart bioaktivt komposit (Giomer) materiale.
Kaviteterne vil blive præpareret efter minimalt invasive principper, isoleret korrekt og genopbygget i henhold til producentens anvisninger ved brug af adhæsiv binding.
Den kliniske præstation vil blive evalueret med hensyn til retention, marginal tilpasning, sekundær caries, postoperativ sensitivitet og den samlede restorationssucces i opfølgningsperioden.
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Eksperimentel: giomer
restoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material.
Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding.
Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period.
|
Resin-Modified Glass Ionomer (RMGI) is a fluoride-releasing restorative material used for the restoration of carious primary teeth.
It combines the properties of conventional glass ionomer cement with resin components to improve mechanical strength, adhesion, and moisture tolerance.
In this study, RMGI will be used for restoring cavitated carious lesions in primary teeth following caries removal according to minimally invasive dentistry principles.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Secondary Caries
Tidsramme: Baseline, 3, 6, and 12 months
|
Assessed using revised FDI criteria (B1: caries at restoration margin).
Evaluated by visual examination and short air drying.
Scored on ordinal scale 1-5.
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Baseline, 3, 6, and 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative sensitivity / pulp status
Tidsramme: Baseline, 3, 6, and 12 months
|
Presence of caries at restoration margin assessed by visual examination using revised FDI criteria (B1), scored 1-5.
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Baseline, 3, 6, and 12 months
|
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Marginal Adaptation
Tidsramme: Baseline, 3, 6, and 12 months
|
Quality of marginal seal between restoration and tooth structure assessed using revised FDI criteria (F2), scored 1-5.
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Baseline, 3, 6, and 12 months
|
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Proximal Contact Point
Tidsramme: Baseline, 3, 6, and 12 months
|
Presence and quality of proximal contact between restored tooth and adjacent tooth assessed using revised FDI criteria (F3), scored 1-5
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Baseline, 3, 6, and 12 months
|
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Occlusal Wear
Tidsramme: Baseline, 3, 6, and 12 months
|
Degree of wear of restoration surface under occlusal loading assessed using revised FDI criteria (F5), scored 1-5
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Baseline, 3, 6, and 12 months
|
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Fracture and Retention
Tidsramme: Baseline, 3, 6, and 12 months
|
Presence of cracks, fractures, or loss of restoration assessed using revised FDI criteria (F1), scored 1-5
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Baseline, 3, 6, and 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Nadine Elshayal, Cairo University
- Ledende efterforsker: Dina Ez Mohamed, Cairo University
- Studieleder: Osama Elshahawy, 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. maj 2026
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. september 2027
Datoer for studieregistrering
Først indsendt
18. februar 2026
Først indsendt, der opfyldte QC-kriterier
24. april 2026
Først opslået (Faktiske)
1. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CairoU-Injectable VS RMGI
Plan for individuelle deltagerdata (IPD)
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