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Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars

18. maj 2026 opdateret af: Maram malik osman alabd, Cairo University

The goal of this clinical trial is to compare pain Perception, patient acceptability, and cavity preparation time between chemo-mechanical caries removal and Atraumatic restorative treatment Method in Primary Molars.

The main questions it aims to answer: "Does chemo-mechanical caries removal show similar results compared to Atraumatic restorative treatment Method in terms of pain perception in Primary Molars?

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques "high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia

Atraumatic Restorative Treatment (ART) is one of the approaches based on this philosophy. It involves the manual removal of carious tissue without the use of local anesthesia or rotary instruments, followed by restoration with glass ionomer cement, an adhesive material that chemically bonds to tooth structure and releases fluoride, promoting remineralization.

Chemo mechanical caries removal (CMCR) is another minimally invasive technique that utilizes chemical agents with proteolytic action to degrade denatured collagen within carious dentin, facilitating its removal without the need for rotary instruments. This technique reduces pain, discomfort, and anxiety, making it particularly suitable for pediatric patients. Additionally, CMCR minimizes the risk of unnecessary removal of healthy tooth structure and may reduce the need for local anesthesia, thereby improving patient cooperation and the overall treatment experience.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Manal Ahmed Elsheikh, prof, PhD

Studiesteder

  • Egypten
      • Cairo, Egypten, 12613
        • Faulty of Dentistry Cairo University
        • Kontakt:

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

Ja

Beskrivelse

Inclusion Criteria:

  1. Healthy children aged between 5 and 9 years.
  2. Children presenting with occlusal caries in mandibular and/or maxillary primary molars Carious lesions without any pulpal involvement.
  3. Children whose parents or guardians have provided written informed consent.

Exclusion Criteria:

1-Children with teeth exhibiting: pulpal exposure, mobility, spontaneous pain, swelling or fistula adjacent to the tooth, furcation involvement, ervical lesions, teeth with sealants, restorations, or enamel defects also exclude .

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A: Chemo-Mechanical Caries Removal (CMCR)
Participants in this arm will receive chemo-mechanical caries removal using REMOVE gel. The procedure includes cleaning the tooth surface with wet cotton pellets, application of REMOVE gel into the cavity, and allowing it to act for approximately 30 seconds. The softened carious tissue is then removed gently without pressure. Remaining Caries become fluorescence under light cure source, and the absence of color change indicates complete removal. Residual gel is removed using sterile wet cotton pellets. Finally, the cavity is restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions.
Andet: Group A: Chemo-Mechanical Caries Removal (CMCR)
Removal of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
Eksperimentel: Group B: Atraumatic Restorative Treatment (ART)
Participants in this arm will receive atraumatic restorative treatment (ART). The procedure involves opening the cavity and removal of carious dentin using a dental excavator . The cavity is clinically evaluated using a sharp explorer, and caries removal is considered complete when the explorer does not stick to dentin or produce a tug-back sensation. The cavity is then restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions.
Andet: Group 2 :Atraumatic Restorative Treatment
Removal of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Perception Measured by Visual Analog Scale (VAS)
Tidsramme: immediately after caries removal

Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). Higher scores represent greater pain intensity.

0: No pain 1-3: mild 4-5: moderate 6-7: Severe 8-9: very severe 10: Worst Pain possible
immediately after caries removal

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Acceptability Assessed by Likert Scale
Tidsramme: Immediately after treatment procedure

Patient acceptability will be evaluated using a 5-point Likert Scale ranging from 1 to 5, where 1 indicates very happy and 5 indicates very unhappy. Higher scores indicate lower patient acceptability.

  1. Very Happy
  2. Happy
  3. Neither
  4. Unhappy
  5. Very Unhappy
Immediately after treatment procedure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Caries removal time measured by stopwatch per minutes
Tidsramme: During the caries removal procedure
The duration of the treatment procedure will be measured in minutes from the beginning of caries removal until completion of the restorative procedure. Higher values indicate longer treatment time.
During the caries removal procedure

Samarbejdspartnere og efterforskere

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

Sponsor

Cairo University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • -Abdel Sattar, R., Nasr, R., Hanafy, R. (2026). 'Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial', Egyptian Dental Journal, 72(1), pp. 25-33. doi: 10.21608/edj.2025.417407.3615

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. september 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PP-NCV-VSART

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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