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- Klinische proef NCT07641933
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases (RCT)
10 juni 2026 bijgewerkt door: Ain Shams University
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial
The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications:
- Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite
- Calcium Silicate
- Calcium Hydroxide
In retreatment cases in terms of:
- Biological Evaluation: Biomarker (IL 1B)
- Radiographic Evaluation: CBCT
- Clinical Evaluation: Pain Score (VAS)
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used.
Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM.
Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl.
Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group).
Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point.
Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage.
Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique.
And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score.
Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.
Studietype
Ingrijpend
Inschrijving (Geschat)
60
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Merna Mamdouh Botros Billatos, Msc
- Telefoonnummer: 00201201579537
- E-mail: mernabotros@dent.asu.edu.eg
Studie Locaties
-
-
-
Cairo, Egypte
- Werving
- Ain Shams University
-
Contact:
- Ain Shams University
- Telefoonnummer: 00201000397491
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusion Criteria:
- Age: 21-45 years.
- Medically free patients. (ASA Class 1)
- Gender: males and females
- Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
- Restorable root canal treated permanent lower first molars with periapical lesions.
- Small (<5 mm) or medium periapical lesion size (5-10 mm)
Exclusion Criteria:
- Patients with a history of allergic reactions to any of the study materials.
- Teeth that become non-restorable after complete caries excavation.
- Teeth that have mobility or deep periodontal pockets.
- Teeth with internal or external resorption.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Calcium Silicate Intracanal Medication
Calcium silicate-based bioceramic Intracanal Medication as Bio C-Temp (Angelus)
|
Calcium silicate-based bioceramic materials have gained attention for their bioactivity and biocompatibility, acting through hydration with calcium hydroxide release followed by hydroxyapatite formation that promotes healing.
Bio-C Temp is an example, characterized by high calcium ion release, alkaline pH, adequate radiopacity, and good biocompatibility.
|
|
Experimenteel: Calcium Hydroxide Slurry mixed with Sodium Hypochlorite
Calcium Hydroxide slurry mixed with 3% Sodium Hypochlorite
|
Combining calcium hydroxide with sodium hypochlorite (NaOCl) has been proposed.
NaOCl provides rapid and potent antimicrobial and tissue-dissolving effects, while Ca(OH)₂ offers prolonged action.
Both agents retain their properties when combined, and this combination may produce a synergistic effect that enhances disinfection and reduces chair time in two-visit treatment protocols.
|
|
Actieve vergelijker: Calcium Hydroxide
Calcium Hydroxide Intracanal Medication (Control Group)
|
Calcium hydroxide ICM being the most widely used due to its high alkalinity, antimicrobial properties, endotoxin neutralization, and ability to reduce periapical inflammation.
It is applied as an aqueous mixture or polyethylene glycol-based paste and provides a slow but sustained antimicrobial effect.
Despite their benefits, Ca(OH)₂ medicaments re limited by their solubility, susceptibility to tissue fluids, potential to weaken tooth structure over time, and reduced effectiveness against resistant microorganisms such as Candida Albicans and Enterococcus Faecalis.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Biological Evaluation of inflammatory marker (IL-1B)
Tijdsspanne: 1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.
|
IL-1B collected by periapical fluid sample using paper points and measured using ELISA.
|
1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Radiographic Evaluation using limited FOV CBCT
Tijdsspanne: 1 year between pre- and post-operative CBCT scans.
|
Pre-operative and post-operative limited FOV CBCT scans are taken to compare volumetric reduction in periapical lesion size.
|
1 year between pre- and post-operative CBCT scans.
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinical Evaluation using Pain Score (Visual Analogue Scale)
Tijdsspanne: Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals
|
evaluation of pain score using Visual Analogue Scale on a scale of 0-10 with 0 representing no pain and 10 representing the most severe pain (subjective)
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Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2026
Primaire voltooiing (Geschat)
1 juni 2027
Studie voltooiing (Geschat)
1 augustus 2027
Studieregistratiedata
Eerst ingediend
7 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 juni 2026
Eerst geplaatst (Werkelijk)
11 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1740
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .