Irrigation SolutionNCT07116252
Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation
A study testing EDTA, Etidronate and clodronate in people with Irrigation Solution and Postoperative Pain, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study aims to improve the postoperative endodontic outcome by assessing the effect of different irrigants on postoperative endodontic pain and their anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irrigation Solution, Postoperative Pain, Inflammation
- What is being tested?
- EDTA, Etidronate and clodronate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting with a single rooted tooth (maxillary anteriors and mandibular premolars) with closed apex and a single patent canal type I in Vertucci's classification (Vertucci et al., 1974)
- Having a necrotic pulp and asymptomatic apical periodontitis (periapical lesion).
- Periapical lesions of endodontic origin with a diameter ranging from 2 to 5mm, having a periapical index score of 4 or 5 (Orstavik, Kerekes and Eriksen, 1986)
Who cannot join
- Patients with pain before treatment (ii) Patients having chronic condition requiring the intake of anti-inflammatory/antibiotic drugs.
- Teeth having non-restorable tooth with gross carious lesions, fractures, internal or external root resorption or cracks involving the periodontium.
- Root canals in which patency for periapical fluid sampling could not be achieved.
- immune-compromised patients or patients with complicated systemic diseases, physical disability or psychological problems (vi) patients received antibiotic therapy within the last 3months. (vii) Teeth associated with bone expansion or with a history of endodontic treatment.
- Teeth with periodontal pockets deeper than 4mm, with or without concomitant or combined endo-perio communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sequential Versus Continous Chelation Protocols on Postoperative Endodontic Pain and Matrix Metalloproteinase-9 Levels: A Randomized Clinical Study
This study aims to improve the postoperative endodontic outcome by assessing the effect of different irrigants on postoperative endodontic pain and their anti-inflammatory effects.
Read the detailed description
Alternating application of ethylenediaminetetraacetic acid (EDTA) and sodium hypochlorite (NaOCl) is frequently recommended for removal of organic and inorganic tissues debris including the smear layer. But EDTA can cause loss of available chlorine affecting organic tissue dissolving ability of NaOCl when mixed with it. Etidronic acid is a first-generation bisphosphonate. It is a mild chelator that is compatible with NaOCl in the short term without affecting available chlorine, a concept that has been termed 'continuous chelation'. Clodronate also, was identified with improved stability in NaOCl mixtures compared with EDTA and etidronate.
Aim: Assessment of postoperative endodontic pain and matrix metalloproteinase-9 levels after sequential versus continous chelation protocols.
Methods: This study will be conducted on 75 patients having necrotic pulp with asymptomatic apical periodontitis. Patients will be randomly divided into five groups (Group 1: 2.5% NaOCl during instrumentation then sequential chelation by 17% EDTA, Group 2: 2.5% NaOCl during instrumentation then sequential chelation by 9% HEBP, Group 3: 2.5% NaOCl during instrumentation then sequential chelation by 0.26 M (7.6%) clodronate, Group 4: continuous chelation during instrumentation by 2.5% NaOCl + 9% HEBP, Group 5: continuous chelation by 2.5% NaOCl + 0.26 M (7.6%) clodronate). Postoperative pain will be assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale. MMP-9 levels in periapical tissues will be quantified using a commercially available ELISA kit applied on the periapical samples that will be collected after the final rinse (S1) and after one week (S2).
- Being tested
- EDTA, Etidronate, clodronate, Etidronic acid /sodium hypochlorite, clodronate + sodium hypochlorite
- Keywords
- Clodronate, HEBP, MMP-9, EDTA, Continous chelation
- Medical subject headings
- Pain, Postoperative, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTAProcedure or surgery
Also called 17% Ethylenediaminetetraacetic Acid.
17% EDTA as a final rinse after instrumentaion (sequential chelation)
EtidronateProcedure or surgery
Also called 9% HEBP or HEDP (1-Hydroxyethylidene-1,1-bisphosphonate)
9% HEBP as a final rinse after instrumentation (sequential chelation)
clodronateProcedure or surgery
Also called 0.26 M (7.6%) clodronate or clodronic acid
0.26 M (7.6%) clodronate as a final rinse after instrumentation (sequential chelation)
Etidronic acid /sodium hypochloriteProcedure or surgery
Also called 2.5% NaOCl + 9% HEBP - continous chelation
(2.5% NaOCl + 9% HEBP) during instrumentation and as a final rinse after instrumentation (continous chelation)
clodronate + sodium hypochloriteProcedure or surgery
Also called 2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation
2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumentation and as a final rinse after instrumentation (continuous chelation)
| Study group | Role | What they receive |
|---|---|---|
| 17% EDTA - sequential chelation | Experimental | Irrigation by 2.5% NaOCl during instrumention and a final rinse by 17% EDTA (sequential chelation protocol) Receives: Procedure: EDTA |
| 9% HEBP - sequential chelation | Experimental | Irrigation by 2.5% NaOCl during instrumention and a final rinse by 9% HEBP (sequential chelation protocol) Receives: Procedure: Etidronate |
| 0.26 M (7.6%) clodronate - sequential chelation | Experimental | Irrigation by 2.5% NaOCl during instrumention and a final rinse by 0.26 M (7.6%) clodronate (sequential chelation protocol) Receives: Procedure: clodronate |
| 2.5% NaOCl + 9% HEBP - continous chelation | Experimental | Irrigation by 2.5% NaOCl + 9% HEBP during instrumention and as final rinse (continous chelation protocol) Receives: Procedure: Etidronic acid /sodium hypochlorite |
| 2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation | Experimental | Irrigation by 2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumention and as final rinse (continous chelation protocol) Receives: Procedure: clodronate + sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment using Numerical Rating Scale NRS
Postoperative pain is assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale NRS where the patient is asked to select the number representing the pain intensity as follow '0' representing no pain and '10' being the worst pain
Measured: Postoperative pain was assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale NRS
MMP-9 levels in periapical tissues using periapical fluid samples using a commercially available ELISA kit
MMP-9 levels in periapical tissues are quantified using a commercially available ELISA kit applied on the periapical samples that will be collected after the final rinse (S1) and after one week (S2).
Measured: After the final rinse (S1) and after one week (S2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start20 Aug 2023
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Irrigation SolutionStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Model description
- 5 groups with different treatment protocols to assess two parameters
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman elkholy, Suez Canal University
- Investigators
- Dalia Fayyad, Study director, Professor of endodontics, faculty of dentistry, Suez Canal UniversityDalia Abdallah, Study director, Associate Professor of endodontics, faculty of dentistry, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116252
- Sponsor's protocol ID
- Endodontics
- Status last verified
- Aug 2025
- First submitted
- 5 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and results
Publications
La Rosa GRM, Plotino G, Nagendrababu V, Pedulla E. Effectiveness of continuous chelation irrigation protocol in endodontics: a scoping review of laboratory studies. Odontology. 2024 Jan;112(1):1-18. doi: 10.1007/s10266-023-00835-8. Epub 2023 Jul 11.
PubMed 37433927Rath PP, Yiu CKY, Matinlinna JP, Kishen A, Neelakantan P. The effects of sequential and continuous chelation on dentin. Dent Mater. 2020 Dec;36(12):1655-1665. doi: 10.1016/j.dental.2020.10.010. Epub 2020 Nov 5.
PubMed 33162115Bassam S, El-Ahmar R, Salloum S, Ayoub S. Endodontic postoperative flare-up: An update. Saudi Dent J. 2021 Nov;33(7):386-394. doi: 10.1016/j.sdentj.2021.05.005. Epub 2021 Jun 3.
PubMed 34803278Ahmed GM, El-Baz AA, Hashem AA, Shalaan AK. Expression levels of matrix metalloproteinase-9 and gram-negative bacteria in symptomatic and asymptomatic periapical lesions. J Endod. 2013 Apr;39(4):444-8. doi: 10.1016/j.joen.2012.11.009. Epub 2013 Jan 16.
PubMed 23522533Zollinger A, Mohn D, Zeltner M, Zehnder M. Short-term storage stability of NaOCl solutions when combined with Dual Rinse HEDP. Int Endod J. 2018 Jun;51(6):691-696. doi: 10.1111/iej.12875. Epub 2017 Dec 5.
PubMed 29121393Wright PP, Cooper C, Kahler B, Walsh LJ. From an assessment of multiple chelators, clodronate has potential for use in continuous chelation. Int Endod J. 2020 Jan;53(1):122-134. doi: 10.1111/iej.13213. Epub 2019 Sep 26.
PubMed 31483863Ballal NV, Gandhi P, Shenoy PA, Shenoy Belle V, Bhat V, Rechenberg DK, Zehnder M. Safety assessment of an etidronate in a sodium hypochlorite solution: randomized double-blind trial. Int Endod J. 2019 Sep;52(9):1274-1282. doi: 10.1111/iej.13129. Epub 2019 May 13.
PubMed 30993696
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sequential Versus Continous Chelation Protocols on Postoperative Endodontic Pain and Matrix Metalloproteinase-9 Levels: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07116252
- Acronym / sponsor ID
- Endodontics
- Keywords
- Clodronate, HEBP, MMP-9, EDTA, Continous chelation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Aug 2025 (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.
This study aims to improve the postoperative endodontic outcome by assessing the effect of different irrigants on postoperative endodontic pain and their anti-inflammatory effects.
Detailed description
Alternating application of ethylenediaminetetraacetic acid (EDTA) and sodium hypochlorite (NaOCl) is frequently recommended for removal of organic and inorganic tissues debris including the smear layer. But EDTA can cause loss of available chlorine affecting organic tissue dissolving ability of NaOCl when mixed with it. Etidronic acid is a first-generation bisphosphonate. It is a mild chelator that is compatible with NaOCl in the short term without affecting available chlorine, a concept that has been termed 'continuous chelation'. Clodronate also, was identified with improved stability in NaOCl mixtures compared with EDTA and etidronate.
Aim: Assessment of postoperative endodontic pain and matrix metalloproteinase-9 levels after sequential versus continous chelation protocols.
Methods: This study will be conducted on 75 patients having necrotic pulp with asymptomatic apical periodontitis. Patients will be randomly divided into five groups (Group 1: 2.5% NaOCl during instrumentation then sequential chelation by 17% EDTA, Group 2: 2.5% NaOCl during instrumentation then sequential chelation by 9% HEBP, Group 3: 2.5% NaOCl during instrumentation then sequential chelation by 0.26 M (7.6%) clodronate, Group 4: continuous chelation during instrumentation by 2.5% NaOCl + 9% HEBP, Group 5: continuous chelation by 2.5% NaOCl + 0.26 M (7.6%) clodronate). Postoperative pain will be assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale. MMP-9 levels in periapical tissues will be quantified using a commercially available ELISA kit applied on the periapical samples that will be collected after the final rinse (S1) and after one week (S2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
- Model description
- 5 groups with different treatment protocols to assess two parameters
| Arm | Type | Receives |
|---|---|---|
| 17% EDTA - sequential chelation | Experimental | Procedure: EDTAIrrigation by 2.5% NaOCl during instrumention and a final rinse by 17% EDTA (sequential chelation protocol) |
| 9% HEBP - sequential chelation | Experimental | Procedure: EtidronateIrrigation by 2.5% NaOCl during instrumention and a final rinse by 9% HEBP (sequential chelation protocol) |
| 0.26 M (7.6%) clodronate - sequential chelation | Experimental | Procedure: clodronateIrrigation by 2.5% NaOCl during instrumention and a final rinse by 0.26 M (7.6%) clodronate (sequential chelation protocol) |
| 2.5% NaOCl + 9% HEBP - continous chelation | Experimental | Procedure: Etidronic acid /sodium hypochloriteIrrigation by 2.5% NaOCl + 9% HEBP during instrumention and as final rinse (continous chelation protocol) |
| 2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation | Experimental | Procedure: clodronate + sodium hypochloriteIrrigation by 2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumention and as final rinse (continous chelation protocol) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients presenting with a single rooted tooth (maxillary anteriors and mandibular premolars) with closed apex and a single patent canal type I in Vertucci's classification (Vertucci et al., 1974)
- Having a necrotic pulp and asymptomatic apical periodontitis (periapical lesion).
- Periapical lesions of endodontic origin with a diameter ranging from 2 to 5mm, having a periapical index score of 4 or 5 (Orstavik, Kerekes and Eriksen, 1986)
Key exclusion criteria (5 listed)
- Patients with pain before treatment (ii) Patients having chronic condition requiring the intake of anti-inflammatory/antibiotic drugs.
- Teeth having non-restorable tooth with gross carious lesions, fractures, internal or external root resorption or cracks involving the periodontium.
- Root canals in which patency for periapical fluid sampling could not be achieved.
- immune-compromised patients or patients with complicated systemic diseases, physical disability or psychological problems (vi) patients received antibiotic therapy within the last 3months. (vii) Teeth associated with bone expansion or with a history of endodontic treatment.
- Teeth with periodontal pockets deeper than 4mm, with or without concomitant or combined endo-perio communication.
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 |
|---|---|---|
| EDTAAlso: 17% Ethylenediaminetetraacetic Acid.17% EDTA as a final rinse after instrumentaion (sequential chelation) | Procedure or surgery | 17% EDTA - sequential chelation |
| EtidronateAlso: 9% HEBP or HEDP (1-Hydroxyethylidene-1,1-bisphosphonate)9% HEBP as a final rinse after instrumentation (sequential chelation) | Procedure or surgery | 9% HEBP - sequential chelation |
| clodronateAlso: 0.26 M (7.6%) clodronate or clodronic acid0.26 M (7.6%) clodronate as a final rinse after instrumentation (sequential chelation) | Procedure or surgery | 0.26 M (7.6%) clodronate - sequential chelation |
| Etidronic acid /sodium hypochloriteAlso: 2.5% NaOCl + 9% HEBP - continous chelation(2.5% NaOCl + 9% HEBP) during instrumentation and as a final rinse after instrumentation (continous chelation) | Procedure or surgery | 2.5% NaOCl + 9% HEBP - continous chelation |
| clodronate + sodium hypochloriteAlso: 2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumentation and as a final rinse after instrumentation (continuous chelation) | Procedure or surgery | 2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation |
Primary outcome
Postoperative pain assessment using Numerical Rating Scale NRS
Time frame: Postoperative pain was assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale NRS
Postoperative pain is assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale NRS where the patient is asked to select the number representing the pain intensity as follow '0' representing no pain and '10' being the worst pain
MMP-9 levels in periapical tissues using periapical fluid samples using a commercially available ELISA kit
Time frame: After the final rinse (S1) and after one week (S2).
MMP-9 levels in periapical tissues are quantified using a commercially available ELISA kit applied on the periapical samples that will be collected after the final rinse (S1) and after one week (S2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 37433927La Rosa GRM, Plotino G, Nagendrababu V, Pedulla E. Effectiveness of continuous chelation irrigation protocol in endodontics: a scoping review of laboratory studies. Odontology. 2024 Jan;112(1):1-18. doi: 10.1007/s10266-023-00835-8. Epub 2023 Jul 11.
- Background: PubMed 33162115Rath PP, Yiu CKY, Matinlinna JP, Kishen A, Neelakantan P. The effects of sequential and continuous chelation on dentin. Dent Mater. 2020 Dec;36(12):1655-1665. doi: 10.1016/j.dental.2020.10.010. Epub 2020 Nov 5.
- Background: PubMed 34803278Bassam S, El-Ahmar R, Salloum S, Ayoub S. Endodontic postoperative flare-up: An update. Saudi Dent J. 2021 Nov;33(7):386-394. doi: 10.1016/j.sdentj.2021.05.005. Epub 2021 Jun 3.
- Background: PubMed 23522533Ahmed GM, El-Baz AA, Hashem AA, Shalaan AK. Expression levels of matrix metalloproteinase-9 and gram-negative bacteria in symptomatic and asymptomatic periapical lesions. J Endod. 2013 Apr;39(4):444-8. doi: 10.1016/j.joen.2012.11.009. Epub 2013 Jan 16.
- Background: PubMed 29121393Zollinger A, Mohn D, Zeltner M, Zehnder M. Short-term storage stability of NaOCl solutions when combined with Dual Rinse HEDP. Int Endod J. 2018 Jun;51(6):691-696. doi: 10.1111/iej.12875. Epub 2017 Dec 5.
- Background: PubMed 31483863Wright PP, Cooper C, Kahler B, Walsh LJ. From an assessment of multiple chelators, clodronate has potential for use in continuous chelation. Int Endod J. 2020 Jan;53(1):122-134. doi: 10.1111/iej.13213. Epub 2019 Sep 26.
- Background: PubMed 30993696Ballal NV, Gandhi P, Shenoy PA, Shenoy Belle V, Bhat V, Rechenberg DK, Zehnder M. Safety assessment of an etidronate in a sodium hypochlorite solution: randomized double-blind trial. Int Endod J. 2019 Sep;52(9):1274-1282. doi: 10.1111/iej.13129. Epub 2019 May 13.
- Individual participant dataSharing planned: Yes. study protocol and results
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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.
Dalia Fayyad study director
Professor of endodontics, faculty of dentistry, Suez Canal University
Dalia Abdallah study director
Associate Professor of endodontics, faculty of dentistry, Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDTA, Etidronate and clodronate in people with Irrigation Solution and Postoperative Pain, run by Suez Canal University at 1 site in Egypt.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative pain assessment using Numerical Rating Scale NRS (time frame: Postoperative pain was assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale NRS). The study lists 2 primary outcomes in all. 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 NCT07116252, 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 11 Aug 2025.