- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04319575
Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant
Clinical and Radiographic Comparative Evaluation of Healing of Periapical Lesion Using Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide When Used as a Root Canal Disinfectant- An In Vivo Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Aim: To evaluate and compare the healing of periapical lesions using chitosan mixed with calcium hydroxide or Triple Antibiotic Paste at 3,6 and 12 months.
Methodology:
20 adult patients having periapical lesions in single rooted teeth were selected in this study after being assessed using the PAI index. Patients were randomly assigned to: Group - I (n=10) Chitosan with Ca (OH)2 and Group -II (n=10) Triple Antibiotic paste (TAP)
After access opening and cleaning and shaping were done in the first visit, the pertinent intracanal medicaments were placed depending on the patient group. After 4 weeks, on the second visit, the medicament was removed andobturation was done in the asymptomatic teeth. Both clinical and radiographic endodontic evaluation was done at 0, 3, 6 and 12months using the same parameters.
Radiographic evaluation was done using the PAI Index and was compared at 0, 3, 6, and 12 months after treatment, Z Test.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Maharashtra
-
Pune, Maharashtra, Indien, 411 018
- Rekrytering
- Dr DY Patil Dental College And Hospital (DPU)
-
Kontakt:
- Soumya S Shetty, MDS
- Telefonnummer: 8888200888
- E-post: drsoumyasshetty@gmail.com
-
Kontakt:
- anita B Tandale, MDS
- Telefonnummer: 9850537432
- E-post: anita.tandale@gmail.com
-
Huvudutredare:
- soumya S shetty, MDS
-
Underutredare:
- anita B tandale, MDS
-
Underutredare:
- piyush D oswal, MDS
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients aged between 18 and 40 years Periapical lesion (not more than 5mm) radiographically.on single rooted teeth
- Roots with closed apex.
- Systemically healthy patients.
Exclusion Criteria:All patients who respond positive to allergic patch test [triple antibiotic paste] and drugs.
- Teeth with previous endodontic therapy performed.
- Patients with a history of any systemic diseases.
- Pregnant and lactating women.
- Tooth associated with vertical root fracture and coronal perforation.
- Tooth affected with calcific degeneration.
- Presence of external or internal root resorption.
- Blunderbuss apex.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Chitosan calcium hyroxide paste
after the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks.
|
after the access preparation and cleaning and shaping was done in 1st appointment using k files,"Mani" and protapers,"Dentsply" then in, chitosan calcium hydroxide paste," or ciprofloxacin metronidazole minocycline paste placed in the canal and kept for 4 weeks.
Andra namn:
|
|
Aktiv komparator: triple antibiotic paste
after the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks.
|
after the access preparation and cleaning and shaping was done in 1st appointment using k files,"Mani" and protapers,"Dentsply" then in, chitosan calcium hydroxide paste," or ciprofloxacin metronidazole minocycline paste placed in the canal and kept for 4 weeks.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
healing of periapical lesion
Tidsram: change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months
|
the periapical status will be assessed by using the periapical index [PAI] using radiographs and scoring was done according to following scoring index as
|
change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
patient pain perception
Tidsram: 3months, 6months and 12 months
|
pain will be assessed using visual analogue (VAS )scale along with any swelling following scale of -10 with 0 score depicts no pain and score 10 depicts severe pain
|
3months, 6months and 12 months
|
Samarbetspartners och utredare
Utredare
- Studierektor: Piyush D Oswal, MDS, Dr. D Y Patil Dental College, Pimpri, Pune
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
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
- DYPV/EC/55/16
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