Faculty of dentistry, suez canal university
Ismailia, Egypt
NCT Number: NCT07116252
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Ismailia, Egypt
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(i) Patients with pain before treatment (ii) Patients having chronic condition requiring the intake of anti-inflammatory/antibiotic drugs.
(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.
17% EDTA as a final rinse after instrumentaion (sequential chelation)
Other names: 17% Ethylenediaminetetraacetic Acid.
9% HEBP as a final rinse after instrumentation (sequential chelation)
Other names: 9% HEBP or HEDP (1-Hydroxyethylidene-1,1-bisphosphonate)
0.26 M (7.6%) clodronate as a final rinse after instrumentation (sequential chelation)
Other names: 0.26 M (7.6%) clodronate or clodronic acid
(2.5% NaOCl + 9% HEBP) during instrumentation and as a final rinse after instrumentation (continous chelation)
Other names: 2.5% NaOCl + 9% HEBP - continous chelation
2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumentation and as a final rinse after instrumentation (continuous chelation)
Other names: 2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation
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
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).
Suez Canal University
Other
Effect of Sequential Versus Continous Chelation Protocols on Postoperative Endodontic Pain and Matrix Metalloproteinase-9 Levels: A Randomized Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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