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NCT Number: NCT07116252

Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, suez canal university

Ismailia, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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.

Treatment and study plan

EDTA

Procedure

17% EDTA as a final rinse after instrumentaion (sequential chelation)

Other names: 17% Ethylenediaminetetraacetic Acid.

Etidronate

Procedure

9% HEBP as a final rinse after instrumentation (sequential chelation)

Other names: 9% HEBP or HEDP (1-Hydroxyethylidene-1,1-bisphosphonate)

clodronate

Procedure

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

Etidronic acid /sodium hypochlorite

Procedure

(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

clodronate + sodium hypochlorite

Procedure

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

Primary outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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