"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
29 april 2020 uppdaterad av: Istanbul Medipol University Hospital
The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation.
The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures.
Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth.
One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied.
The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week.
Postoperative pain will be recorded by each patient by using visual analogue pain scale.
Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants.
The local anesthetic will be applied before the treatment start.
The routine retreatment procedure will be applied.
Different final irrigation solutions will be applied in accordance to the manufacturers' instructions.
At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week.
After one week the teeth will be examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.
Studietyp
Interventionell
Inskrivning (Förväntat)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
-Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
Patients who were not included the study who;
- were pregnant or breast feeding during the duration of the study,
- have systemic disease, have any pain and/or any facial swelling, abscess,
- were immunocompromised,
- were under 18 yrs. and over 65 yrs. age,
- were taking antibiotics or corticosteroids within previous three days,
- have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- have root canals that could not be well-treated with orthograde retreatment.
Exclusion Criteria:
-The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at point "0".
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will be opened.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimentell: Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at point "0" and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimentell: Non Apical enlargement
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
|
Experimentell: Non Apical enlargement + Sonic Activation Assisted Irrigation
Routine retreatment procedure will be performed at working length according to the apex locator at 1mm shorter than "0" point and sonic activation assisted irrigation will be applied.
|
The teeth in this group will be treated according to the guidelines for retreatment in single-session.
The filling will remove and cavity will open.
The working length will be measured using apex locator and 1 mm shorter than the "0" point will be based on.
After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals.
Then the teeth were obturated with gutta percha and root canal sealer.
Coronal restoration will complete using composite and/or fully crown if necessary.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
Tidsram: Baseline, 12, 24, 48, 72 hours and 1 week.
|
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale.
Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment.
The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm.
Mild pain was defined as greater than 0 mm and less than or equal to 25 mm.
Mild pain included the descriptors of weak and mild pain.
Moderate pain was defined as greater than 50 mm and less than 75 mm.
Intense pain was defined as equal to or greater than 75 mm.
Intense pain included the descriptors of strong, severe, and maximum possible.
|
Baseline, 12, 24, 48, 72 hours and 1 week.
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
10 juni 2020
Primärt slutförande (Förväntat)
10 oktober 2020
Avslutad studie (Förväntat)
10 december 2021
Studieregistreringsdatum
Först inskickad
17 mars 2020
Först inskickad som uppfyllde QC-kriterierna
18 mars 2020
Första postat (Faktisk)
19 mars 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 april 2020
Senast verifierad
1 mars 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 224 (registration study)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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