- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07641933
Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases (RCT)
10 juni 2026 uppdaterad 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)
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Merna Mamdouh Botros Billatos, Msc
- Telefonnummer: 00201201579537
- E-post: mernabotros@dent.asu.edu.eg
Studieorter
-
-
-
Cairo, Egypten
- Rekrytering
- Ain Shams University
-
Kontakt:
- Ain Shams University
- Telefonnummer: 00201000397491
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Biological Evaluation of inflammatory marker (IL-1B)
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Radiographic Evaluation using limited FOV CBCT
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical Evaluation using Pain Score (Visual Analogue Scale)
Tidsram: 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)
|
Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 augusti 2027
Studieregistreringsdatum
Först inskickad
7 juni 2026
Först inskickad som uppfyllde QC-kriterierna
7 juni 2026
Första postat (Faktisk)
11 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1740
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