Dental Pulp DiseaseNCT05555563
Effect of MTAD on The Outcome of Primary Root Canal Treatment
A study testing MTAD irrigation in people with Dental Pulp Disease and Periapical Diseases, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Disease, Periapical Diseases, Tooth, Nonvital
- What is being tested?
- MTAD irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 20 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of MTAD on The Outcome of Primary Root Canal Treatment: A Randomized Controlled Trial
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'.
Read the 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.
- Conditions
- Dental Pulp Disease, Periapical Diseases, Tooth, Nonvital
- Being tested
- MTAD irrigation
- Keywords
- Apical periodontitis, Biopure MTAD, Randomized Clinical Trial
- Medical subject headings
- Dental Pulp Diseases, Periapical Diseases, Tooth, Nonvital, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTAD irrigationOther
Also called Aysin Dumani
Final irrigation protocol was performed using 5 ml MTAD (n=50).
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: Other: MTAD irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Oct 2019
- Primary completion15 Feb 2020
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp DiseaseStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkcan Yıldız, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555563
- Sponsor's protocol ID
- TDH-2019-12197
- Status last verified
- Sep 2022
- First submitted
- 27 Jun 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12701769Mozayeni 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.
PubMed 19452675Verma 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.
PubMed 30827769Huumonen 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.
PubMed 23385425Ng 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.
PubMed 17931389Orstavik 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.
PubMed 3457698Tosun 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.
PubMed 34556458
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MTAD on The Outcome of Primary Root Canal Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05555563
- Acronym / sponsor ID
- TDH-2019-12197
- Conditions
- Dental Pulp Disease, Periapical Diseases, Tooth, Nonvital
- Keywords
- Apical periodontitis, Biopure MTAD, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: MTAD irrigationRoot 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'. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTAD irrigationAlso: Aysin DumaniFinal irrigation protocol was performed using 5 ml MTAD (n=50). | Other | MTAD irrigation |
Primary outcome
Healing of periapical lesions by radiographic findings according to periapical index (PAI).
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Results publication: PubMed 12701769Torabinejad 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.
- Results publication: PubMed 19452675Mozayeni 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 publication: PubMed 30827769Verma 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 publication: PubMed 23385425Huumonen 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 publication: PubMed 17931389Ng 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 publication: PubMed 3457698Orstavik 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 publication: PubMed 34556458Tosun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTAD irrigation in people with Dental Pulp Disease and Periapical Diseases, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of periapical lesions by radiographic findings according to periapical index (PAI). (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555563, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.