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- Klinische proef NCT03770871
Indirect Pulp Treatment in Primary Molars (RCT)
Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Cairo, Egypte, 11553
- Faculty of Oral and Dental Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion criteria:
In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"
In addition to:
I-Subjects:
- Medically free children, their parent(s) accepts to sign the informed consent.
- Age range from 4-8 years.
II-Molars:
- Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
- Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
- Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).
Exclusion criteria:
I-Subjects:
- Uncooperative children.
- Parents unable to attend follow up visits (even after explaining the importance of recall visits).
II-Molars:
- History of spontaneous pain (to exclude reversible pulpitis).
- Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
- Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: IPT using Dycal (TM )
Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
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Partial caries removal and protection of the dental pulp with biocompatible material
Andere namen:
Partial caries removal and protection of the dental pulp with biocompatible material
Andere namen:
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Experimenteel: IPT using Vitrebond (TM )
Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
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Partial caries removal and protection of the dental pulp with biocompatible material
Andere namen:
Partial caries removal and protection of the dental pulp with biocompatible material
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of cases reporting postoperative pain
Tijdsspanne: 12 months
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Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
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12 months
|
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Number of cases reporting swelling
Tijdsspanne: 12 months
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Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
|
12 months
|
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Number of cases reporting sinus
Tijdsspanne: 12 months
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Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
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12 months
|
|
Number of cases reporting fistula
Tijdsspanne: 12 months
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Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
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12 months
|
|
Number of cases reporting tooth mobility
Tijdsspanne: 12 months
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Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
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12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of cases reporting external root resorption
Tijdsspanne: 12 months
|
Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
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12 months
|
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Number of cases reporting internal root resorption
Tijdsspanne: 12 months
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Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
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12 months
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Number of cases reporting furcation involvement
Tijdsspanne: 12 months
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Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
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12 months
|
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Number of cases reporting widening of periodontal membrane space
Tijdsspanne: 12 months
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Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
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12 months
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Number of cases reporting periapical radiolucency
Tijdsspanne: 12 months
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Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
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12 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Shereen E Taha, Professor, Cairo University
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CEBD-CU-2014-11-3
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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