- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07598188
Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit RCT
Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit Root Canal Treatment in Teeth With Symptomatic Apical Periodontitis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Objective:
To compare the reduction in post operative pain of treatment group with control group using normal; saline at room temperature at 24 and 48 hours
Methodology:
A total of 60 patients presenting with single-rooted teeth exhibiting symptomatic apical periodontitis were subjected to a randomized allocation into two groups of 30 each. Irrigation was done using 3% sodium hypochlorite for 5 seconds in all 60 teeth. Group 1 underwent final irrigation utilizing normal saline at room temperature. Group 2 received final irrigation using normal saline refrigerated between 2-5°C. Pain levels were assessed and recorded before the procedure and at 24 and 48-hour time intervals.
Statistical analysis:
Statistical packages for the Social Sciences (SPSS) Version 22 will be used for data analysis. Mean and SD and Frequencies will be used for quantitative variables (Age and pain), and frequency and percentage for qualitative variable (gender). The continuous variable pain score will be compared among control and cryotherapy group by using independent sample t test. Effect modifiers ( age and gender) will be stratified by using post stratified independent sample t test .The P value < 0.05 will be considered as the threshold for statistical significance, at a confidence interval of 95%.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Aroosa Bakhtawar, BDS
- Telefonnummer: 03379248459
- E-mail: bakhtawararoosa@gmail.com
Undersøgelse Kontakt Backup
- Navn: Saima Azam, BDS, FCPS
- Telefonnummer: 00923005350740
- E-mail: saima.azam@iideas.edu.pk
Studiesteder
-
-
Federal
-
Islamabad, Federal, Pakistan, 44000
- Islamabad Dental Hospital
-
Kontakt:
- Aroosa Bakhtawar, BDS
- Telefonnummer: 03379248459
- E-mail: bakhtawararoosa@gmail.com
-
Kontakt:
- Saima Azam, BDS, FCPS
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Individual (male/female) with age >18 years with symptomatic apical periodontitis in permanent teeth
Exclusion Criteria:
- Teeth with calcified canals or aberrant root anatomy,
- Female Pregnant patients
- Patients using medications such as analgesics or anti-biotics drugs and
- Those who refuse to participate in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group
In the cryotherapy group, following completion of biomechanical preparation, the root canals will be irrigated with 20ml of 0.9% physiological saline solution at a temperature of 1.5-2.5°C
for 5 min
|
In this study participant are suing 0.9% normal saline but the temperature will be different for both groups .In cryotherapy group participant are using saline at cold temperature1.5-2.5°C
|
|
Ingen indgriben: Control Group
In the control group, final irrigation will be performed using 20 mL of 0.9% physiological saline solution at room temperature for 5 min
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the reduction of postoperative pain
Tidsramme: 24-48 hours
|
Patients will be instructed to record their pain score on VAS at 24 and 48 h. and will be asked to contact and visit in case they experience severe pain.
If visit is not possible,a telephonic feedback will be recorded and assistance will be guided
|
24-48 hours
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IslamabadDentalHospital(IDH)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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