Adjunctive Oral Probiotics in Endodontic Retreatment: Effects on Postoperative Pain and RANKL/OPG Levels (RANKL/OPG)
1. juli 2026 oppdatert av: Amina Mamdouh Badawy, Ain Shams University
The Effect of Systemic Administration of Probiotics and Intra-Canal Medications on Level of Nuclear Factor Kappa B Ligand, Osteoprotegerin and Postoperative Pain in Patients With Chronic Apical Periodontitis: (Randomized Controlled Clinical Trial)
This study aimed to evaluate the effect of oral administration of probiotics as an adjunctive treatment to local intracanal medicaments, namely propolis and calcium hydroxide or empty canal, on the levels of receptor activator of nuclear factor kappa B ligand (RANKL) and osteoprotegerin (OPG), as well as on postoperative pain following root canal retreatment of teeth with chronic apical periodontitis
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Post-treatment chronic apical periodontitis is an inflammatory condition caused by persistent microbial infection within the root canal system, characterized by progressive periapical bone destruction mediated by host immune-inflammatory mechanisms. Root canal retreatment remains the treatment of choice for failed endodontic cases; however, postoperative pain and incomplete resolution of inflammatory mediators remain common concerns. Clinical evidence demonstrates that postoperative pain following endodontic retreatment is influenced by microbial persistence, host inflammatory response, and intracanal medication protocols.
The RANK/RANKL/OPG axis is a key regulator of osteoclastic activity and periapical bone resorption. Elevated RANKL levels and altered RANKL/OPG ratio are associated with active periapical bone destruction. Modulation of this pathway may improve healing outcomes. Recent studies suggest that probiotics can regulate immune response, reduce inflammatory cytokines, and decrease RANKL expression.
This randomized clinical trial includes patients diagnosed with previously root-filled teeth presenting with chronic apical periodontitis indicated for non-surgical retreatment.
Standardized retreatment procedures are performed under aseptic conditions. Periapical exudate samples collected for biochemical analysis of RANKL and OPG levels at predetermined time points. Postoperative pain is assessed to investigate whether systemic probiotic administration can act as a host-modulating adjunct in endodontic retreatment and improve both symptomatic and biological healing outcomes.
Studietype
Intervensjonell
Registrering (Faktiske)
72
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Cairo Governorate
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Cairo, Cairo Governorate, Egypt, 11566
- Faculty of dentistry, Ain shams university
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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
Nei
Beskrivelse
Inclusion Criteria:
- Previously treated failed single rooted teeth with chronic apical periodontitis.
- No use of antibiotic three months before treatment.
- Patients are free of any systemic disease.
- Positive patient acceptance for participation
Exclusion Criteria:
- Teeth that are badly broken down with difficult isolation.
- Signs of acute infection, root fracture, root surface caries, swellings or ankylosis
- Periodontally affected teeth with pockets deeper than 4mm.
- Pregnant or lactating woman.
- Patients who needs any prophylactic antibiotic.
- Patients with allergy to pollen.
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Oral probiotics + Local Ca(OH)2 ICM
Following endodontic retreatment, calcium hydroxide placed as an intracanal medicament .
Participants receive Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis ), one capsule daily for 21 days.
|
Linex Adult® is an oral probiotic formulation containing Lactobacillus acidophilus, Bifidobacterium animalis, It is administered as one capsule once daily for 21 days.
Andre navn:
Intracanal medication kept for 21 days
Andre navn:
|
|
Eksperimentell: Oral probiotics + Local Propolis ICM
Following endodontic retreatment, propolis placed as an intracanal medicament.
Participants receive Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis), one capsule daily for 21 days.
|
Linex Adult® is an oral probiotic formulation containing Lactobacillus acidophilus, Bifidobacterium animalis, It is administered as one capsule once daily for 21 days.
Andre navn:
Intracanal medication kept for 21 days
Andre navn:
|
|
Eksperimentell: Oral probiotics + Empty canal
Following endodontic retreatment, the canal was left empty without intracanal medicament.
Participants received Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis), one capsule daily for 21 days.
|
Linex Adult® is an oral probiotic formulation containing Lactobacillus acidophilus, Bifidobacterium animalis, It is administered as one capsule once daily for 21 days.
Andre navn:
Empty canal for 21 days
Andre navn:
|
|
Aktiv komparator: Oral placebo + Local Ca(OH)2 ICM
Following endodontic retreatment, Ca(OH)2 was placed as an intracanal medicament.
Participants received placebo, one capsule daily for 21 days
|
Intracanal medication kept for 21 days
Andre navn:
Placebo capsule for 21 days
Andre navn:
|
|
Aktiv komparator: Oral placebo+ Local propolis ICM
Following endodontic retreatment, propolis was placed as an intracanal medicament.
Participants received placebo, one capsule daily for 21 days
|
Intracanal medication kept for 21 days
Andre navn:
Placebo capsule for 21 days
Andre navn:
|
|
Placebo komparator: Oral placebo + Empty canal
Following endodontic retreatment, the canal was left empty without intracanal medicament.
Participants received Linex Adult® (oral probiotics: Lactobacillus acidophilus, Bifidobacterium animalis), one capsule daily for 21 days.
|
Empty canal for 21 days
Andre navn:
Placebo capsule for 21 days
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The effect on RANKL and OPG levels in teeth with chronic apical periodontitis.
Tidsramme: (S1) measured in the first visit Immediately post-instrumentation and before ICM placement or oral supplement administration. (S2) After 21 days, immediately after removal of ICM and before obturation.
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Level of RANKL and OPG measured with periapical samples (S1) and (S2) and analysed using ELISA test
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(S1) measured in the first visit Immediately post-instrumentation and before ICM placement or oral supplement administration. (S2) After 21 days, immediately after removal of ICM and before obturation.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The effect on postoperative pain.
Tidsramme: Inter-appointment pain: baseline (start of the first visit), 4, 12, 24, 48, and 72 hours, and Week 1 and Week 2 after the first visit. Post-obturation pain: baseline (start of the second visit), 4, 12, 24, 48, and 72 hours after obturation.
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Pain level measured using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain), to evaluate inter-appointment pain between the first and second retreatment visits and post-obturation pain after the second retreatment visit and root canal obturation.
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Inter-appointment pain: baseline (start of the first visit), 4, 12, 24, 48, and 72 hours, and Week 1 and Week 2 after the first visit. Post-obturation pain: baseline (start of the second visit), 4, 12, 24, 48, and 72 hours after obturation.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Abeer A.Elhakim El Gendy, PHD, Professor of Endodontics, AinShams university
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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)
4. oktober 2025
Primær fullføring (Faktiske)
4. juni 2026
Studiet fullført (Faktiske)
20. juni 2026
Datoer for studieregistrering
Først innsendt
26. juni 2026
Først innsendt som oppfylte QC-kriteriene
1. juli 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- END 20-15 P
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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Nei
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