- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07641933
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases (RCT)
10. juni 2026 oppdatert av: 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)
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
60
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Merna Mamdouh Botros Billatos, Msc
- Telefonnummer: 00201201579537
- E-post: mernabotros@dent.asu.edu.eg
Studiesteder
-
-
-
Cairo, Egypt
- Rekruttering
- Ain Shams University
-
Ta kontakt med:
- Ain Shams University
- Telefonnummer: 00201000397491
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Biological Evaluation of inflammatory marker (IL-1B)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiographic Evaluation using limited FOV CBCT
Tidsramme: 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.
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1 year between pre- and post-operative CBCT scans.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Evaluation using Pain Score (Visual Analogue Scale)
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2027
Studiet fullført (Antatt)
1. august 2027
Datoer for studieregistrering
Først innsendt
7. juni 2026
Først innsendt som oppfylte QC-kriteriene
7. juni 2026
Først lagt ut (Faktiske)
11. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1740
Plan for individuelle deltakerdata (IPD)
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