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Effect of MTAD on The Outcome of Primary Root Canal Treatment

Primary Purpose

Dental Pulp Disease, Periapical Diseases, Tooth, Nonvital

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MTAD irrigation
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Disease focused on measuring Apical periodontitis, Biopure MTAD, Randomized Clinical Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

MTAD irrigation

Arm Description

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'.

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'.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 27, 2022
Last Updated
September 22, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05555563
Brief Title
Effect of MTAD on The Outcome of Primary Root Canal Treatment
Official Title
Effect of MTAD on The Outcome of Primary Root Canal Treatment: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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'.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Disease, Periapical Diseases, Tooth, Nonvital
Keywords
Apical periodontitis, Biopure MTAD, Randomized Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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'.
Arm Title
MTAD irrigation
Arm Type
Experimental
Arm Description
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'.
Intervention Type
Other
Intervention Name(s)
MTAD irrigation
Other Intervention Name(s)
Aysin Dumani
Intervention Description
Final irrigation protocol was performed using 5 ml MTAD (n=50).
Primary Outcome Measure Information:
Title
Healing of periapical lesions by radiographic findings according to periapical index (PAI).
Description
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
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01120
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12701769
Citation
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. Erratum In: J Endod. 2003 Jun;29(6):424.
Results Reference
result
PubMed Identifier
19452675
Citation
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.
Results Reference
result
PubMed Identifier
30827769
Citation
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.
Results Reference
result
PubMed Identifier
23385425
Citation
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.
Results Reference
result
PubMed Identifier
17931389
Citation
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.
Results Reference
result
PubMed Identifier
3457698
Citation
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.
Results Reference
result
PubMed Identifier
34556458
Citation
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.
Results Reference
result

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Effect of MTAD on The Outcome of Primary Root Canal Treatment

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