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Comparison of Post-operative Pain Frequency

22 giugno 2021 aggiornato da: Hma Tanvir, Fatima Memorial Hospital

Comparison of Post-operative Pain Frequency in Non-vital Teeth After Single Visit Root Canal Versus Multiple Visit Root Canal Treatment

The objective of this study is:

  • To compare the post-operative pain frequency after single visit root canal versus multiple visit root canal treatment in patients with non-vital teeth
  • Post-operative pain is less frequent after single visit root canal than multiple visit root canal treatment in patients with non-vital teeth.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

METHODOLOGY This Randomized control trial was done in Outdoor patients Department of Operative Dentistry at Fatima Memorial Hospital. Informed written consent was taken from all patients who were willing to participate in the study. Patients who were diagnosed with non-vital teeth were considered for this study. Socio-demographic data and symptoms were recorded, subjects were examined and relevant investigations (vitality tests and radiographs) carried out. The patients were randomly divided into two groups through lottery method. Group A the treatment was done in one visit while in group B treatment was completed in two visits.

The standard procedure for both groups at first visit was administration of local anesthesia (1.8ml 2% Lignocaine with 1:10000 epinephrine), standard access cavity preparation followed by rubber dam isolation and pulp extirpation. After the confirmation of canal patency and working length radiograph, canals were prepared with the combination of hand files and engine-driven rotary nickel-titanium files (DENTSPLY Maillefer, Ballaigues, Switzerland) following manufacturer's instructions. 17%Ethylenediaminetetraacetic acid (EDTA )gel was used as a lubricant. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the first visit, all teeth were prepared to working length and dried with paper points. Canals in Group A were filled with protaper universal gutta-percha (DENTSPLY Maillefer) and calcium hydroxide based sealer and restored with permanent restorative material in the same visit. In Group B after the canal preparation non-setting calcium hydroxide paste was placed with a sterile dry cotton pellet in the canal and tooth was restored with a minimum of 3.0mm Cavit. Patients in Group 2 were recalled after 1 week and the obturation technique same as Group 1 was followed in the second visit. After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on Visual Analogue Scale (VAS) scale was considered as absence of pain.

The data was entered and analyzed in the SPSS-20. For descriptive analysis, mean and standard deviation was reported for age. Percentage for male and female participants was presented for gender distribution. The incidence of post-operative pain for single visit root canal and multiple visit root canal was determined. A chi-square test was used to determine the frequency of post-operative pain in both groups. A P value of 0.05 or less was taken as significant. Data was stratified more scientific manner in Pakistani population. So, the results of this study would add to the literature about the better, time saving and less painful (ROOT CANAL TREATMENT)RCT strategy in term of post- operative pain management.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

302

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Punjab
      • Lahore, Punjab, Pakistan, 53000
        • Huma Tanvir

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 40 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • • Patients within age range 20-40 years.

    • Male/Female
    • Mature permanent first and second molar teeth (maxillary and mandibular)
    • Non-vital teeth (As defined in operational definitions)

Exclusion Criteria:

  • • Any contraindication to local anesthesia, e.g. known allergy

    • Pregnancy.
    • endodontic re-treatment cases
    • Any physical or mental condition that would prevent jaw opening for the time required to complete the treatment.
    • Local acute infection/periapical radiolucency (diagnosed clinically, radio graphically )

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: single visit root canal treatment(RCT)
RCT(ROOT CANAL TREATMENT) of this group was performed in single visit including access cavity, chemo-mechanical preparation and obturation, all were done in one visit
Clinical endodontics involved in the goal of preventing and treating microbial contamination of pulps comprises of a number of treatments. Root canal endodontic therapy has one specific set of aims: to cure or prevent peri-radicular periodontitis, to conserve their natural teeth in function and aesthetics.
Sperimentale: Multiple visit root canal treatment(RCT)
RCT(ROOT CANAL TREATMENT) of this group was performed in multiple visit including access cavity, chemo-mechanical preparation and obturation, all were done in two or three visits
Clinical endodontics involved in the goal of preventing and treating microbial contamination of pulps comprises of a number of treatments. Root canal endodontic therapy has one specific set of aims: to cure or prevent peri-radicular periodontitis, to conserve their natural teeth in function and aesthetics.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Comprision of Post-Operative pain Frequency
Lasso di tempo: 6 months
After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on VAS scale was considered as absence of pain
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Huma Tanvir, BDS, Fatima Memorial Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 marzo 2019

Completamento primario (Effettivo)

28 febbraio 2020

Completamento dello studio (Effettivo)

28 febbraio 2020

Date di iscrizione allo studio

Primo inviato

18 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2021

Primo Inserito (Effettivo)

29 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 giugno 2021

Ultimo verificato

1 giugno 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 14345

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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