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Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files

16. september 2021 opdateret af: Ahmad Elheeny, Minia University

Postoperative Pain After Pulpectomy of Primary Molars Using With Rotary Versus Reciprocation Motions of Two Single Files: A Randomized Clinical Trial

An equivalent parallel randomized clinical trial was approved by the local University Committee of Ethics. 260 children with necrotic primary molars were allocated into 2 equal groups (82 children per group). The participants were allocated into two groups; group "1" teeth were instrumented with OneShape rotary system (Micro Mega, Besancon, France), and group "2" teeth were instrumented with WaveOne Gold reciprocating system (Dentsply Maillefer, Ballaigues, Switzerland). Postoperative pain was assessed using a four-point pain intensity rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four faces with a brief title describing each face representing a scale from the first face (score 1), second face (score 2), third face (score 3), and forth face (score 4) 3. Postoperative pain was assessed at 6 six time intervals (at 6, 12, 24, 48, 72 hours and one-week).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

260

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Egypten
    • Minia
      • Minya, Minia, Egypten, 61111
        • Ngwa Khattab

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 år til 8 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Children ages from 4 to 8 years classified as class I or II according to the American Society of Anesthesiologists (ASA).
  2. No previous dental experience.
  3. Non-vital primary molar (necrotic or with chronic apical periodontitis) which confirmed radiographicly with the presence or absence of periapical radiolucency.
  4. Severe tooth mobility.

Exclusion Criteria:

  1. Severe behaviour or emotional disabilities.
  2. Analgesic intake in the preceding 12 hours.
  3. Non-restorable crowns of primary molars.
  4. Radiographic presence of internal root resorption or massive bone destruction.

  5. Root resorption exceeded one-third of the root length.

    -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Rotary motion using OneShape single file
File size 25 with a taper of 0.06 was mounted to a 6:1 speed-reduction headpiece powered by X Smart Plus endomotor (Dentsply Maillefer, Ballaigues, Switzerland). The speed and torque were set to 400 rpm and 1 N.cm torque, respectively. In a picking motion without pressure, mechanical preparation began with the first RC two-thirds followed by the next 3 mm followed by the full WL.
Enhed: OneSahpe single file
The rotary motion of OneShape single file
Aktiv komparator: Reciprocating motion using WaveOne Gold single file
A Primary file size 25 a taper of 0.07 was installed to pre-programmed reciprocation angles and speed for the WaveOne system handpiece of an endomotor (X Smart Plus endomotor (Dentsply Maillefer, Ballaigues, Switzerland). After ensuring a passive fit of the hand file along the predetermined WL, the RC coronal two-thirds was initially instrumented then followed by the full WL.
Enhed: WaveOne Gold single file
reciprocation motions of WaveOne Gold single file

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pain
Tidsramme: One week
Postoperative pain was assessed using a four-point pain intensity rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four faces with a brief title describing each face representing a scale from the first face (score 1), second face (score 2), third face (score 3), and fourth face (score 4) 17. Postoperative pain was assessed at 6 six time intervals
One week

Samarbejdspartnere og efterforskere

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Sponsor

Minia University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. november 2020

Primær færdiggørelse (Faktiske)

31. august 2021

Studieafslutning (Faktiske)

31. august 2021

Datoer for studieregistrering

Først indsendt

13. september 2021

Først indsendt, der opfyldte QC-kriterier

16. september 2021

Først opslået (Faktiske)

28. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 122/2020

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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