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Active, not recruiting Not applicable

Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation

NCT07116252 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2023-08-20
Last updated
2025-08-11

Condition(s) studied

Irrigation SolutionPostoperative PainInflammationEndodontic Treatment

Investigational drug(s) / intervention(s)

EDTAEtidronateclodronateEtidronic acid /sodium hypochloriteclodronate + sodium hypochlorite

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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. 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) 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: (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.

Primary outcome measure(s)

  • Postoperative pain assessment using Numerical Rating Scale NRS — 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 — 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).

Trial sites (1)

FacilityCityRegionStatus
Faculty of dentistry, suez canal university Ismailia Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07116252 on ClinicalTrials.gov ↗ ← All trials in Egypt