HealthyNCT06597825
Antibacterial Effect of NaOCl With Etidronic Acid in Apical Periodontitis Treatment
A study testing root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP) in people with Healthy, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Sodium hypochlorite (NaOCl), the most commonly used irrigation solution during chemomechanical preparation, plays a significant role in eliminating bacteria within root canals. Additionally, after preparation with different concentrations of NaOCl, 30% to 70% resistant bacteria were observed in the root canals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2020to 10 Jan 2021
- 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
- The study included teeth from patients aged 18-65 years who had no systemic disease and had not undergone antibiotic therapy in the past three months. To ensure standardization, all the treatments were performed by a single clinician.
- A minimum of 2 years since the initial root canal treatment
- Single rooted mandibular premolar with apical periodontitis (AP) and a canal filling within 4 mm from the apex on radiographic examination
- The absence of pain on palpation and percussion, healthy periodontal tissues, and no mobility,
- Presence of a coronal restoration (teeth that have not retained permanent restoration over the previous root canal treatment).
Who cannot join
- Patients who have received antibiotic therapy in the last 3 months,
- Patients with diabetes, pregnancy, immunosuppression and cardiovascular disease,
- Absence of a coronal restoration
- Presence of pain on palpation and percussion, mobility.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University Dentistry Faculty Department of Endodontics
Antakya, Hatay, 31060
About this study
Official title: Antibacterial Effect of Sodium Hypochlorite Combined With Etidronic Acid in Apical Periodontitis Treatment: A Prospective, Single Blinded, Randomised Clinical Trial
Sodium hypochlorite (NaOCl), the most commonly used irrigation solution during chemomechanical preparation, plays a significant role in eliminating bacteria within root canals. Additionally, after preparation with different concentrations of NaOCl, 30% to 70% resistant bacteria were observed in the root canals. For this reason, new protocols have been developed to increase the effectiveness of NaOCl in chemomechanical preparation and to support disinfection within root canals. Recently, etidronic acid (1-hydroxyethane 1,1-diphosphonic acid [HEDP]), a biocompatible chelating agent, has emerged as an alternative irrigation solution. It has been suggested to combine and use this solution with NaOCl.
This study aims to evaluate the antimicrobial effectiveness of NaOCl in the root canal, which is used in combination with HEDP or sequentially with Ethylenediaminetetraacetic acid (EDTA) in the final irrigation after retreatment. Additionally, the effect of activation with Endoactivator (EA) on microbial reduction was assessed.
- Conditions
- Healthy
- Being tested
- root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)
- Keywords
- Bacterial reduction, etidronic acid, root canal irrigation, sodium hypochlorite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)Drug
Also called Root canal irrigation activation (Endoactivator) (Device)
After cavity preparation with sterile burs, rubber dam components were applied to the tooth. The root canal filling material was removed via retreatment files. After the working length was determined, in all the groups, the canals were filled with distilled water. S1were taken from the canal after retreatment. Irrigation protocols were applied for 4 groups. S2 were taken from the canal. Intracanal medicament was placed in the root canal, the cavity was securely sealed. After 14 days,the medicament was removed with 10 mL of 17% EDTA and subsequently irrigated with 5 ml of distilled water, S3 was taken by sterile paper points. The final irrigation was performed according to the group to which the tooth belonged, and S4 was collected as before. the root canals were dried with sterile paper points and filled gutta-percha master cones and sealer.
| Study group | Role | What they receive |
|---|---|---|
| İrrigation protocols (Group I) | Experimental | Group I: the root canal was irrigated with 1 ml of 17% EDTA (Microvem, Istanbul, Turkey), and the solution was kept in the canal for 1 minute. The canal was subsequently irrigated with 2 ml of distilled water and 3 ml of 2.5% NaOCl for 1 minute. Receives: Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP) |
| İrrigation protocols (Group II) | Experimental | Group II: HEDP (DualRinse HEDP, Medcem, Vienna, Austria), containing 0.9 mg of etidronic acid per capsule, was added to 10 ml of 2.5% NaOCl in a sterile container according to the manufacturer's instructions. The solution, which was prepared just before use in the canal, was mixed for 1 min to ensure that the powder was fully dissolved. The canal was then irrigated with 4 ml of the 2.5% NaOCl - 9% HEDP combined solution for 2 minutes. Receives: Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP) |
| İrrigation protocols (Group III) | Experimental | Group III: A similar irrigation protocol to that of Group I was followed, with an additional 1-minute sonic activation using the EA device on 3 ml of 2.5% NaOCl. The tip of the EA was placed 2 mm away from the WL and the irrigant was activated with 10,000 cycles per minute with a tip size 0.04/35. Receives: Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP) |
| İrrigation protocols (Group IV) | Experimental | Group IV: Similar to Group II, the canal was filled with 4 ml of the 2.5% NaOCl - 9% HEDP combined solution for 1 minute. The tip of the EA was placed 2 mm away from the WL, followed by 1 minute of sonic activation with the EA device (10,000 cycles per minute with a tip size 0.04/35). Receives: Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bacterial load (CFU/ml) in root canal samples of teeth
In all the groups, A sterile paper point of size R50 was placed at the working length (WL) and left in the canal for 1 minute. Three paper points were then placed into an Eppendorf tube containing phosphate-buffered saline (PBS). The samples taken from the canal after retreatment were recorded as the S1. After root canal preparation and irrigation protocols, S2 sample was taken. After dried protocol, medicament was placed in the root canal.After 14 days,the intracanal medicament was removed with 17% EDTA. The root canal was irrigated with 5 ml of distilled water.S3 was taken by sterile R50 paper points. The final irrigation was performed according to the group to which the tooth belonged,the S4 was collected as before.Each sample obtained from the patient was placed into culture medium.The inoculated plates were incubated at 37°C for 48 hours. After incubation, the total bacterial counts were determined by calculating the number of colony-forming units (CFU/ml) on the plates.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Aug 2020
- Primary completion23 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Tufenkci, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597825
- Sponsor's protocol ID
- Clinical Research-2019/37
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Siqueira JF Jr, Rôças IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod 2008;34:1291-12301.e3. 2. Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod 2009;35:493-502. 3. Zandi H, Petronijevic N, Mdala I, et al. Outcome of endodontic retreatment using 2 root canal irrigants and influence of infection on healing as determined by a molecular method: a randomized clinical trial. J Endod 2019;45:1089-10898.e5. 4. Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Ørstavik D, Rôças IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. 5. Rôças IN, Provenzano JC, Neves MA, Siqueira JF Jr. Disinfecting Effects of Rotary Instrumentation with Either 2.5% Sodium Hypochlorite or 2% Chlorhexidine as the Main Irrigant: A Randomized Clinical Study. J Endod. 2016 Jun;42(6):943-7. 6. Paiva SS, Siqueira JF Jr, Rôças IN, Carmo FL, Ferreira DC, Curvelo JA, Soares RM, Rosado AS. Supplementing the antimicrobial effects of chemomechanical debridement with either passive ultrasonic irrigation or a final rinse with chlorhexidine: a clinical study. J Endod. 2012 Sep;38(9):1202-6. 7. Siqueira JF Jr, Rôças IN. Optimizing single-visit disinfection with supplementary approaches: a quest for predictability. Aust Endod J 2011;37:92-8.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Effect of Sodium Hypochlorite Combined With Etidronic Acid in Apical Periodontitis Treatment: A Prospective, Single Blinded, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06597825
- Acronym / sponsor ID
- Clinical Research-2019/37
- Conditions
- Healthy
- Keywords
- Bacterial reduction, etidronic acid, root canal irrigation, sodium hypochlorite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 19 Sep 2024 (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.
Sodium hypochlorite (NaOCl), the most commonly used irrigation solution during chemomechanical preparation, plays a significant role in eliminating bacteria within root canals. Additionally, after preparation with different concentrations of NaOCl, 30% to 70% resistant bacteria were observed in the root canals. For this reason, new protocols have been developed to increase the effectiveness of NaOCl in chemomechanical preparation and to support disinfection within root canals. Recently, etidronic acid (1-hydroxyethane 1,1-diphosphonic acid [HEDP]), a biocompatible chelating agent, has emerged as an alternative irrigation solution. It has been suggested to combine and use this solution with NaOCl.
This study aims to evaluate the antimicrobial effectiveness of NaOCl in the root canal, which is used in combination with HEDP or sequentially with Ethylenediaminetetraacetic acid (EDTA) in the final irrigation after retreatment. Additionally, the effect of activation with Endoactivator (EA) on microbial reduction was assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| İrrigation protocols (Group I) | Experimental | Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)Group I: the root canal was irrigated with 1 ml of 17% EDTA (Microvem, Istanbul, Turkey), and the solution was kept in the canal for 1 minute. The canal was subsequently irrigated with 2 ml of distilled water and 3 ml of 2.5% NaOCl for 1 minute. |
| İrrigation protocols (Group II) | Experimental | Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)Group II: HEDP (DualRinse HEDP, Medcem, Vienna, Austria), containing 0.9 mg of etidronic acid per capsule, was added to 10 ml of 2.5% NaOCl in a sterile container according to the manufacturer's instructions. The solution, which was prepared just before use in the canal, was mixed for 1 min to ensure that the powder was fully dissolved. The canal was then irrigated with 4 ml of the 2.5% NaOCl - 9% HEDP combined solution for 2 minutes. |
| İrrigation protocols (Group III) | Experimental | Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)Group III: A similar irrigation protocol to that of Group I was followed, with an additional 1-minute sonic activation using the EA device on 3 ml of 2.5% NaOCl. The tip of the EA was placed 2 mm away from the WL and the irrigant was activated with 10,000 cycles per minute with a tip size 0.04/35. |
| İrrigation protocols (Group IV) | Experimental | Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)Group IV: Similar to Group II, the canal was filled with 4 ml of the 2.5% NaOCl - 9% HEDP combined solution for 1 minute. The tip of the EA was placed 2 mm away from the WL, followed by 1 minute of sonic activation with the EA device (10,000 cycles per minute with a tip size 0.04/35). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The study included teeth from patients aged 18-65 years who had no systemic disease and had not undergone antibiotic therapy in the past three months. To ensure standardization, all the treatments were performed by a single clinician.
- A minimum of 2 years since the initial root canal treatment
- Single rooted mandibular premolar with apical periodontitis (AP) and a canal filling within 4 mm from the apex on radiographic examination
- The absence of pain on palpation and percussion, healthy periodontal tissues, and no mobility,
- Presence of a coronal restoration (teeth that have not retained permanent restoration over the previous root canal treatment).
Key exclusion criteria (4 listed)
- Patients who have received antibiotic therapy in the last 3 months,
- Patients with diabetes, pregnancy, immunosuppression and cardiovascular disease,
- Absence of a coronal restoration
- Presence of pain on palpation and percussion, mobility.
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 |
|---|---|---|
| root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)Also: Root canal irrigation activation (Endoactivator) (Device)After cavity preparation with sterile burs, rubber dam components were applied to the tooth. The root canal filling material was removed via retreatment files. After the working length was determined, in all the groups, the canals were filled with distilled water. S1were taken from the canal after retreatment. Irrigation protocols were applied for 4 groups. S2 were taken from the canal. Intracanal medicament was placed in the root canal, the cavity was securely sealed. After 14 days,the medicament was removed with 10 mL of 17% EDTA and subsequently irrigated with 5 ml of distilled water, S3 was taken by sterile paper points. The final irrigation was performed according to the group to which the tooth belonged, and S4 was collected as before. the root canals were dried with sterile paper points and filled gutta-percha master cones and sealer. | Drug | İrrigation protocols (Group I), İrrigation protocols (Group II), İrrigation protocols (Group III), İrrigation protocols (Group IV) |
Primary outcome
Total bacterial load (CFU/ml) in root canal samples of teeth
Time frame: From enrollment to the end of treatment at 2 weeks
In all the groups, A sterile paper point of size R50 was placed at the working length (WL) and left in the canal for 1 minute. Three paper points were then placed into an Eppendorf tube containing phosphate-buffered saline (PBS). The samples taken from the canal after retreatment were recorded as the S1. After root canal preparation and irrigation protocols, S2 sample was taken. After dried protocol, medicament was placed in the root canal.After 14 days,the intracanal medicament was removed with 17% EDTA. The root canal was irrigated with 5 ml of distilled water.S3 was taken by sterile R50 paper points. The final irrigation was performed according to the group to which the tooth belonged,the S4 was collected as before.Each sample obtained from the patient was placed into culture medium.The inoculated plates were incubated at 37°C for 48 hours. After incubation, the total bacterial counts were determined by calculating the number of colony-forming units (CFU/ml) on the plates.
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 19 Sep 2024.
- Results publication1. Siqueira JF Jr, Rôças IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod 2008;34:1291-12301.e3. 2. Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod 2009;35:493-502. 3. Zandi H, Petronijevic N, Mdala I, et al. Outcome of endodontic retreatment using 2 root canal irrigants and influence of infection on healing as determined by a molecular method: a randomized clinical trial. J Endod 2019;45:1089-10898.e5. 4. Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Ørstavik D, Rôças IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. 5. Rôças IN, Provenzano JC, Neves MA, Siqueira JF Jr. Disinfecting Effects of Rotary Instrumentation with Either 2.5% Sodium Hypochlorite or 2% Chlorhexidine as the Main Irrigant: A Randomized Clinical Study. J Endod. 2016 Jun;42(6):943-7. 6. Paiva SS, Siqueira JF Jr, Rôças IN, Carmo FL, Ferreira DC, Curvelo JA, Soares RM, Rosado AS. Supplementing the antimicrobial effects of chemomechanical debridement with either passive ultrasonic irrigation or a final rinse with chlorhexidine: a clinical study. J Endod. 2012 Sep;38(9):1202-6. 7. Siqueira JF Jr, Rôças IN. Optimizing single-visit disinfection with supplementary approaches: a quest for predictability. Aust Endod J 2011;37:92-8.
- 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 root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP) in people with Healthy, run by Mustafa Kemal 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 5 inclusion and 4 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 19 Sep 2024. 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?
Total bacterial load (CFU/ml) in root canal samples of teeth (time frame: From enrollment to the end of treatment at 2 weeks). 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 NCT06597825, which also lists 1 linked publication.
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 19 Sep 2024.