NCT07116252

Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation

Effect of Sequential Versus Continous Chelation Protocols on Postoperative Endodontic Pain and Matrix Metalloproteinase-9 Levels: A Randomized Clinical Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Irrigation Solution
• Postoperative Pain
• Inflammation
• Endodontic Treatment

Interventions

Type	Name	Description
PROCEDURE	EDTA	17% EDTA as a final rinse after instrumentaion (sequential chelation)
PROCEDURE	Etidronate	9% HEBP as a final rinse after instrumentation (sequential chelation)
PROCEDURE	clodronate	0.26 M (7.6%) clodronate as a final rinse after instrumentation (sequential chelation)
PROCEDURE	Etidronic acid /sodium hypochlorite	(2.5% NaOCl + 9% HEBP) during instrumentation and as a final rinse after instrumentation (continous chelation)
PROCEDURE	clodronate + sodium hypochlorite	2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumentation and as a final rinse after instrumentation (continuous chelation)

Timeline

• Start date: 2023-08-20
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: Egypt