Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447519
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-27
Brief Title:
Multiple-Visit RCT in Teeth With SAP Interappointment Dressing or Not
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
Clinical and Radiographic Outcomes of Multiple-Visit Non-Surgical Root Canal Treatment in Permanent Teeth With Symptomatic Apical Periodontitis Interappointment Dressing or Not A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCTCaOH2
Brief Summary:
The aim of the study is to evaluate the effectiveness of calcium hydroxide as an intracanal medicament in the clinical and radiographic healing of periapical tissues in teeth diagnosed with symptomatic apical periodontitis This evaluation will be conducted after multiple visit endodontic treatment The follow-up sessions will be programmed from 6 to 24 months postoperatively Postoperative pain will also be considered as a secondary outcome Participants will be asked to rate their pain level on a numerical scale from 0 to10 before and after each session of endodontic treatment Additionally the use of analgesics after the procedure will be measured and the incidence of flare-ups will be evaluated Two study groups will be formed to undergo multiple-visit endodontic treatment The intervention group will receive intracanal medication of calcium hydroxide while the control group will have the root canal left empty between appointments
Detailed Description:
The first visit will include the following clinical steps After administering local anesthesia with 4 articaine hydrochloride and epinephrine injection with 1200000 adrenaline or 2 mepivacaine for an inferior alveolar block all decayed tissue from the tooth will be removed The tooth will be isolated with a rubber dam the tooth crown will be disinfected with 2 NaOCl and an access cavity preparation will be created The 10 C-Pilot file will be used to create a glide path The working length will be established with an apex locator and an x-ray The root canal will be instrumented using the sequence of NiTi rotary files Edge Endo X7 The canals will be irrigated copiously with 10ml of 2 NaOCl each time Following instrumentation a final rinse with 10ml of 2 NaOCl 10ml of 17 EDTA and 10ml of saline solution will be performed Group 1 will receive intracanal dressing with Ca OH2 paste using Lentulo for a period of 7-10 days Group 2 will be left without intracanal dressing for a period of 7-10 days In both groups teeth will be restored with glass ionomer cement GIC as a temporary restoration The final visit will include the following clinical steps After examining the tooth and surrounding tissues local anesthesia will be administered as previously described The temporary restorative material will be removed and the tooth will be isolated with a rubber dam before accessing the root canal In Group 1 the intracanal dressing will be removed through irrigation and then obturated using a standardized matched size and taper gutta-percha cone with AH-plus sealer with the single-cone obturation technique The tooth will be then temporarily restored with glass ionomer cement GIC and the participant will be referred for final restoration within 7-14 days The same protocol is followed for Group 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None