Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation
NCT ID: NCT07116252
Last Updated: 2025-08-11
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
75 participants
INTERVENTIONAL
2023-08-20
2025-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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17% EDTA - sequential chelation
Irrigation by 2.5% NaOCl during instrumention and a final rinse by 17% EDTA (sequential chelation protocol)
EDTA
17% EDTA as a final rinse after instrumentaion (sequential chelation)
9% HEBP - sequential chelation
Irrigation by 2.5% NaOCl during instrumention and a final rinse by 9% HEBP (sequential chelation protocol)
Etidronate
9% HEBP as a final rinse after instrumentation (sequential chelation)
0.26 M (7.6%) clodronate - sequential chelation
Irrigation by 2.5% NaOCl during instrumention and a final rinse by 0.26 M (7.6%) clodronate (sequential chelation protocol)
clodronate
0.26 M (7.6%) clodronate as a final rinse after instrumentation (sequential chelation)
2.5% NaOCl + 9% HEBP - continous chelation
Irrigation by 2.5% NaOCl + 9% HEBP during instrumention and as final rinse (continous chelation protocol)
Etidronic acid /sodium hypochlorite
(2.5% NaOCl + 9% HEBP) during instrumentation and as a final rinse after instrumentation (continous chelation)
2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation
Irrigation by 2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumention and as final rinse (continous chelation protocol)
clodronate + sodium hypochlorite
2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumentation and as a final rinse after instrumentation (continuous chelation)
Interventions
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EDTA
17% EDTA as a final rinse after instrumentaion (sequential chelation)
Etidronate
9% HEBP as a final rinse after instrumentation (sequential chelation)
clodronate
0.26 M (7.6%) clodronate as a final rinse after instrumentation (sequential chelation)
Etidronic acid /sodium hypochlorite
(2.5% NaOCl + 9% HEBP) during instrumentation and as a final rinse after instrumentation (continous chelation)
clodronate + sodium hypochlorite
2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumentation and as a final rinse after instrumentation (continuous chelation)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Having a necrotic pulp and asymptomatic apical periodontitis (periapical lesion).
3. 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)
Exclusion Criteria
(iii) Teeth having non-restorable tooth with gross carious lesions, fractures, internal or external root resorption or cracks involving the periodontium.
(iv) Root canals in which patency for periapical fluid sampling could not be achieved.
(v) 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.
(viii) Teeth with periodontal pockets deeper than 4mm, with or without concomitant or combined endo-perio communication.
18 Years
60 Years
ALL
Yes
Sponsors
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Suez Canal University
OTHER
Responsible Party
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Abdelrahman elkholy
Assisstant lecturer of endodontics
Principal Investigators
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Dalia Fayyad
Role: STUDY_DIRECTOR
Professor of endodontics, faculty of dentistry, Suez Canal University
Dalia Abdallah
Role: STUDY_DIRECTOR
Associate Professor of endodontics, faculty of dentistry, Suez Canal University
Locations
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Faculty of dentistry, suez canal university
Ismailia, , Egypt
Countries
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References
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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.
Rath 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.
Bassam 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.
Ahmed 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.
Zollinger 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.
Wright 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.
Ballal 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.
Other Identifiers
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Endodontics
Identifier Type: -
Identifier Source: org_study_id
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