"Effect of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain"
29 april 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
10 juni 2020
Primaire voltooiing (Verwacht)
10 oktober 2020
Studie voltooiing (Verwacht)
10 december 2021
Studieregistratiedata
Eerst ingediend
17 maart 2020
Eerst ingediend dat voldeed aan de QC-criteria
18 maart 2020
Eerst geplaatst (Werkelijk)
19 maart 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 mei 2020
Laatste update ingediend die voldeed aan QC-criteria
29 april 2020
Laatst geverifieerd
1 maart 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 224 (registration study)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .