Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05555563
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2022-06-27
Brief Title:
Effect of MTAD on The Outcome of Primary Root Canal Treatment
Sponsor:
Cukurova University
Organization:
Cukurova University
Study Overview
Official Title:
Effect of MTAD on The Outcome of Primary Root Canal Treatment A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-09
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:
None
Brief Summary:
The aim of this clinical study was to compare the radiographic outcome of a root canal treatment with or without use of MTAD after 24 months recall This in vivo study was a prospective single-center single blinded parallel and randomized clinical trial The study protocol was approved by the Ethics Committee of Cukurova University Faculty of Medicine
One hundred patients with a noncontributory medical history presented to the Department of Endodontics of the University of Cukurova Faculty of Dentistry between October 2019 and February 2020 were selected according to inclusion and exclusion criteria All selected teeth were single-rooted maxillary and mandibular incisors canines or premolars that were asymptomatic no preoperative pain swelling or acute endodontic or periodontal abscess All pulps were nonvital and did not respond to cold testing All patients were aged between 18 and 65 years had no systemic diseases or allergies tolocal anaesthetic agents had not previously received any endodontic treatment and had no radiographic evidence of periapical bone loss Pregnant and breast-feeding women and patients taking analgesic anti-inflammatory or antibiotic medications during the 7 days prior to the beginning of treatment were also excluded All patients were informed that they were to be included in a clinical trial and their consent was obtainedThe initial periapical radiographs of the patients were taken with the digital imaging system Digora Optime Soredex Tuusula Finland by long-cone paralleling technique with a film holder Endo Rh plus Indusbello Londrina PR Brazil the vitality of the pulp was evaluated by an electronic vitalometer Analytic Technology Corp Redmond WA USA and confirmed by the absence of bleeding from the endodontic access cavity
For both maxillary and mandibular teeth local infil-tration anaesthesia was achieved using 2 mL articaine hydrochloride with 1200 000 adrenaline Maxicaine VEM Ilac Istanbul Turkey Endodontic access preparations were performed using diamond round burs After the canals were visible patency was checked with a K-file VDW GmbH Munich Germany and a dental dam was placed to isolate the tooth The working length WL was determined with an electronic apex locator Raypex 6VDW and accepted when all 3 green bars were reached In addition the canal length was confirmed by a periapical radiograph and the apex locator was accepted as correct in situations where the two did not match Root canal instrumentation was performed using the Reciproc Blue VDW Munich 5005 file During instrumentation of the root canals irrigation was applied with 10 mL 25 NaOCl using side-vented needles NaviTips 30 gauge Ultradent South Jordan UT USA The final irrigation in Control group was applied with 5 ml of 17 EDTA solution and 5 ml of distilled water In the MTAD group final irrigation was done with 5 mL of MTAD and 5 mL of distilled water Side-vented needles were placed 1 mm shorter than the working length and 5 ml of solution was given in 2 minutes The root canals were dried with sterile paper points and were filled with cold lateral condensation technique using AH Plus root canal sealer Dentsply Maillefer Cologne Germany and gutta percha President Dental Duisburg Germany Then the cavity entry was restored with composite Solarex GC Corparation Tokyo Japan and radiography was taken Patients were invited to follow-up sessions at 6 12 18 and 24 months and were radiographically and clinically assessed Many patients missed their follow-up appointments due to the covid 19 pandemic The follow-up radiographs performed by long-cone paralleling technique with a film holder The pre-treatment and 24-month follow-up radiographs of teeth were prepared as a Power Point presentation Microsoft Corporation Redmond WA and the change in periapical radiolucency was assessed according to PAI scores of five categories 1 Normal apical periodontium 2 Small changes in bone structures 3 Change in bone structure with mineral loss 4 Periodontitis with well-defined radiolucent area 5 Severe periodontitis with exacerbating features Teeth with a PAI 2 score and clinically asymptomatic were considered healthy in the radiographic evaluation while teeth with a PAI 3 andor clinically symptomatic were considered failure
One hundred patients with a noncontributory medical history presented to the Department of Endodontics of the University of Cukurova Faculty of Dentistry between October 2019 and February 2020 were selected according to inclusion and exclusion criteria All selected teeth were single-rooted maxillary and mandibular incisors canines or premolars that were asymptomatic no preoperative pain swelling or acute endodontic or periodontal abscess All pulps were nonvital and did not respond to cold testing All patients were aged between 18 and 65 years had no systemic diseases or allergies tolocal anaesthetic agents had not previously received any endodontic treatment and had no radiographic evidence of periapical bone loss Pregnant and breast-feeding women and patients taking analgesic anti-inflammatory or antibiotic medications during the 7 days prior to the beginning of treatment were also excluded All patients were informed that they were to be included in a clinical trial and their consent was obtainedThe initial periapical radiographs of the patients were taken with the digital imaging system Digora Optime Soredex Tuusula Finland by long-cone paralleling technique with a film holder Endo Rh plus Indusbello Londrina PR Brazil the vitality of the pulp was evaluated by an electronic vitalometer Analytic Technology Corp Redmond WA USA and confirmed by the absence of bleeding from the endodontic access cavity
For both maxillary and mandibular teeth local infil-tration anaesthesia was achieved using 2 mL articaine hydrochloride with 1200 000 adrenaline Maxicaine VEM Ilac Istanbul Turkey Endodontic access preparations were performed using diamond round burs After the canals were visible patency was checked with a K-file VDW GmbH Munich Germany and a dental dam was placed to isolate the tooth The working length WL was determined with an electronic apex locator Raypex 6VDW and accepted when all 3 green bars were reached In addition the canal length was confirmed by a periapical radiograph and the apex locator was accepted as correct in situations where the two did not match Root canal instrumentation was performed using the Reciproc Blue VDW Munich 5005 file During instrumentation of the root canals irrigation was applied with 10 mL 25 NaOCl using side-vented needles NaviTips 30 gauge Ultradent South Jordan UT USA The final irrigation in Control group was applied with 5 ml of 17 EDTA solution and 5 ml of distilled water In the MTAD group final irrigation was done with 5 mL of MTAD and 5 mL of distilled water Side-vented needles were placed 1 mm shorter than the working length and 5 ml of solution was given in 2 minutes The root canals were dried with sterile paper points and were filled with cold lateral condensation technique using AH Plus root canal sealer Dentsply Maillefer Cologne Germany and gutta percha President Dental Duisburg Germany Then the cavity entry was restored with composite Solarex GC Corparation Tokyo Japan and radiography was taken Patients were invited to follow-up sessions at 6 12 18 and 24 months and were radiographically and clinically assessed Many patients missed their follow-up appointments due to the covid 19 pandemic The follow-up radiographs performed by long-cone paralleling technique with a film holder The pre-treatment and 24-month follow-up radiographs of teeth were prepared as a Power Point presentation Microsoft Corporation Redmond WA and the change in periapical radiolucency was assessed according to PAI scores of five categories 1 Normal apical periodontium 2 Small changes in bone structures 3 Change in bone structure with mineral loss 4 Periodontitis with well-defined radiolucent area 5 Severe periodontitis with exacerbating features Teeth with a PAI 2 score and clinically asymptomatic were considered healthy in the radiographic evaluation while teeth with a PAI 3 andor clinically symptomatic were considered failure
Detailed Description:
This randomized controlled clinical trial was conducted to evaluate radiographic periapical repair after endodontic treatment using 5 mL of MTAD and 5 mL of distilled water MTAD group or 5 ml of 17 EDTA solution and 5 ml of distilled water Control group irrigation in single-rooted teeth with apical periodontitis
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?:
None
Is an FDA AA801 Violation?:
None