- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
-
Cairo, Egypten, 11553
- Faculty of oral and dental medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: IPT using Dycal (TM )
Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
|
Partial caries removal and protection of the dental pulp with biocompatible material
Andra namn:
Partial caries removal and protection of the dental pulp with biocompatible material
Andra namn:
|
Experimentell: IPT using Vitrebond (TM )
Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
|
Partial caries removal and protection of the dental pulp with biocompatible material
Andra namn:
Partial caries removal and protection of the dental pulp with biocompatible material
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of cases reporting postoperative pain
Tidsram: 12 months
|
Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
|
12 months
|
Number of cases reporting swelling
Tidsram: 12 months
|
Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
|
12 months
|
Number of cases reporting sinus
Tidsram: 12 months
|
Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
|
12 months
|
Number of cases reporting fistula
Tidsram: 12 months
|
Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
|
12 months
|
Number of cases reporting tooth mobility
Tidsram: 12 months
|
Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of cases reporting external root resorption
Tidsram: 12 months
|
Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
Number of cases reporting internal root resorption
Tidsram: 12 months
|
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
Number of cases reporting furcation involvement
Tidsram: 12 months
|
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
Number of cases reporting widening of periodontal membrane space
Tidsram: 12 months
|
Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
Number of cases reporting periapical radiolucency
Tidsram: 12 months
|
Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Shereen E Taha, Professor, Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CEBD-CU-2014-11-3
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Karies
-
Federal University of PelotasOkändDental restaurering misslyckande | Estetik, Dental | Dentala restaureringar Lång livslängdBrasilien
-
Altamash Institute of Dental MedicineAvslutadMedicinsk utbildning | Dental | Instruktionsmetoder | Dental Crown Preparation | TräningseffektivitetPakistan
-
Minia UniversityAvslutad
-
Claude Bernard UniversityUniversity of NancyRekryteringDental felställningFrankrike
-
RevBioRekrytering
-
RevBioAvslutad
-
Christopher BarwaczAvslutadEstetik, Dental | Dental Implant, Single-ToothFörenta staterna
-
University of ZagrebEge University; University of Belgrade; University of MilanAktiv, inte rekryterandeDental restaureringKroatien, Italien, Serbien, Kalkon
-
Ain Shams UniversityRekrytering