NCT05555563

Effect of MTAD on The Outcome of Primary Root Canal Treatment

Completed NA Last updated 27 September 2022

What this trial tests

NA trial testing MTAD irrigation in Dental Pulp Disease in 100 participants. Completed in 20 February 2022.

Timeline

1 October 2019

Primary endpoint
15 February 2020

20 February 2022

Quick facts

Lead sponsor	Cukurova University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 October 2019
Primary completion	15 February 2020
Estimated completion	20 February 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• MTAD irrigation

Conditions studied

• Dental Pulp Disease — all drugs for Dental Pulp Disease →
• Periapical Diseases — all drugs for Periapical Diseases →
• Tooth, Nonvital — all drugs for Tooth, Nonvital →

Sponsor

Cukurova University

Who can join

Adults 18 to 65, any sex, with Dental Pulp Disease or Periapical Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 obtained.The 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 1:200 000 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 6,VDW) 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) #50/0.5 file. During instrumentation of the root canals, irrigation was applied with 10 mL 2.5% 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 and/or clinically symptomatic were considered 'failure'.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.