Effect of MTAD on The Outcome of Primary Root Canal Treatment

NCT05555563 | Completed

• 1 other identifier: TDH-2019-12197
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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'.

Conditions

Dental Pulp Disease; Periapical Diseases; Tooth, Nonvital

Keywords

Apical periodontitis; Biopure MTAD; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Healing of periapical lesions by radiographic findings according to periapical index (PAI).

  The periapical index (PAI) is structured scoring system for categorization of radiographic features of apical lesion. It is based on a visual scale of periapical periodontitis severity and was built upon a classical study of histological-radiological correlations. It is a five-point ordinal scale as listed below: 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.and MTAD group

  Long-term follow-up evaluation in 24 months. Each patient will recall for an appointment and the periapical status of the tooth will be evaluated by periapical radiograph.

Study Arms (2)

Control

NO INTERVENTION

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. The final irrigation in Control group was applied with 5 ml of 17% EDTA solution and 5 ml of distilled water. The root canals were dried with sterile paper points and were filled with cold lateral condensation technique using AH Plus root canal sealer and gutta percha. Then the cavity entry was restored with composite (Solarex, GC Corparation, Tokyo, Japan) and radiography was taken. The pre-treatment and 24-month follow-up radiographs of teeth, were prepared as a Power Point presentation and the change in periapical radiolucency was assessed according to PAI scores 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'.

MTAD irrigation

EXPERIMENTAL

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. The final irrigation in MTAD group was applied 5 ml MTAD (n=50) and 5 ml of distilled water. The root canals were dried with sterile paper points and were filled with cold lateral condensation technique using AH Plus root canal sealer and gutta percha. Then the cavity entry was restored with composite (Solarex, GC Corparation, Tokyo, Japan) and radiography was taken. The pre-treatment and 24-month follow-up radiographs of teeth, were prepared as a Power Point presentation and the change in periapical radiolucency was assessed according to PAI scores 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'.

Other: MTAD irrigation

Interventions

MTAD irrigation OTHER

Final irrigation protocol was performed using 5 ml MTAD (n=50).

Also known as: Aysin Dumani

MTAD irrigation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No systemic diseases
• No history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment
• All selected teeth were necrotic, single root teeth with a periapical lesion ( 2\>PAI ≤5 mm)

You may not qualify if:

• Systemic and/or periodontal disease
• Allergy to local anesthetic agents and/or histrory of intolerance to nonsteroidal anti-inflammatory drugs;
• Requirement for antibiotic prophylaxis
• Open tooth apex
• Pacemaker use
• Women were pregnant or breastfeeding status

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01120, Turkey (Türkiye)

Location

Related Publications (7)

• Torabinejad M, Cho Y, Khademi AA, Bakland LK, Shabahang S. The effect of various concentrations of sodium hypochlorite on the ability of MTAD to remove the smear layer. J Endod. 2003 Apr;29(4):233-9. doi: 10.1097/00004770-200304000-00001.

  PMID: 12701769 RESULT

• Mozayeni MA, Javaheri GH, Poorroosta P, Ashari MA, Javaheri HH. Effect of 17% EDTA and MTAD on intracanal smear layer removal: a scanning electron microscopic study. Aust Endod J. 2009 Apr;35(1):13-7. doi: 10.1111/j.1747-4477.2007.00111.x.

  PMID: 19452675 RESULT

• Verma N, Sangwan P, Tewari S, Duhan J. Effect of Different Concentrations of Sodium Hypochlorite on Outcome of Primary Root Canal Treatment: A Randomized Controlled Trial. J Endod. 2019 Apr;45(4):357-363. doi: 10.1016/j.joen.2019.01.003. Epub 2019 Mar 1.

  PMID: 30827769 RESULT

• Huumonen S, Orstavik D. Radiographic follow-up of periapical status after endodontic treatment of teeth with and without apical periodontitis. Clin Oral Investig. 2013 Dec;17(9):2099-104. doi: 10.1007/s00784-013-0926-2. Epub 2013 Feb 5.

  PMID: 23385425 RESULT

• Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10.

  PMID: 17931389 RESULT

• Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.

  PMID: 3457698 RESULT

• Tosun S, Karataslioglu E, Tulgar MM, Derindag G. Fractal analysis and periapical index evaluation of multivisit nonsurgical endodontic retreatment: A retrospective study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 Feb;133(2):245-251. doi: 10.1016/j.oooo.2021.08.016. Epub 2021 Aug 30.

  PMID: 34556458 RESULT

MeSH Terms

Conditions

Dental Pulp Diseases; Periapical Diseases; Tooth, Nonvital; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: September 27, 2022
• Study Start: October 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 20, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)