Effect of MTAD on The Outcome of Primary Root Canal Treatment
Condition: Dental Pulp Disease; Periapical Diseases; Tooth, Nonvital
MeSH terms: Periapical Diseases; Dental Pulp Diseases; Tooth, Nonvital
Study type: Interventional

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 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'.
    

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.
    

Intervention name(s): MTAD irrigation
Intervention type(s): Other
Intervention description(s): Final irrigation protocol was performed using 5 ml MTAD (n=50).
Other intervention name(s): Aysin Dumani
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Apical periodontitis; Biopure MTAD; Randomized Clinical Trial