Effect of Different Irrigation Protocols on Postoperative Endodontic Pain and Inflammation

NCT07116252 | Active Not Recruiting

• 1 other identifier: Endodontics
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irrigation Solution; Postoperative Pain; Inflammation; Endodontic Treatment

Keywords

Clodronate; HEBP; MMP-9; EDTA; Continous chelation

Outcome Measures

Primary Outcomes (2)

• Postoperative pain assessment using 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

  Postoperative pain was assessed after 6, 12, 24, 48 hours and 7 days after the first visit using a numerical rating scale NRS

• MMP-9 levels in periapical tissues using periapical fluid samples using a commercially available ELISA kit

  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).

  After the final rinse (S1) and after one week (S2).

Study Arms (5)

17% EDTA - sequential chelation

EXPERIMENTAL

Irrigation by 2.5% NaOCl during instrumention and a final rinse by 17% EDTA (sequential chelation protocol)

Procedure: EDTA

9% HEBP - sequential chelation

EXPERIMENTAL

Irrigation by 2.5% NaOCl during instrumention and a final rinse by 9% HEBP (sequential chelation protocol)

Procedure: Etidronate

0.26 M (7.6%) clodronate - sequential chelation

EXPERIMENTAL

Irrigation by 2.5% NaOCl during instrumention and a final rinse by 0.26 M (7.6%) clodronate (sequential chelation protocol)

Procedure: clodronate

2.5% NaOCl + 9% HEBP - continous chelation

EXPERIMENTAL

Irrigation by 2.5% NaOCl + 9% HEBP during instrumention and as final rinse (continous chelation protocol)

Procedure: Etidronic acid /sodium hypochlorite

2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation

EXPERIMENTAL

Irrigation by 2.5% NaOCl + 0.26 M (7.6%) clodronate during instrumention and as final rinse (continous chelation protocol)

Procedure: clodronate + sodium hypochlorite

Interventions

EDTA PROCEDURE

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

Also known as: 17% Ethylenediaminetetraacetic Acid.

17% EDTA - sequential chelation

Etidronate PROCEDURE

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

Also known as: 9% HEBP or HEDP (1-Hydroxyethylidene-1,1-bisphosphonate)

9% HEBP - sequential chelation

clodronate PROCEDURE

0.26 M (7.6%) clodronate as a final rinse after instrumentation (sequential chelation)

Also known as: 0.26 M (7.6%) clodronate or clodronic acid

0.26 M (7.6%) clodronate - sequential chelation

Etidronic acid /sodium hypochlorite PROCEDURE

(2.5% NaOCl + 9% HEBP) during instrumentation and as a final rinse after instrumentation (continous chelation)

Also known as: 2.5% NaOCl + 9% HEBP - continous chelation

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)

Also known as: 2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation

2.5% NaOCl + 0.26 M (7.6%) clodronate - continuous chelation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• (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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of dentistry, suez canal university

Ismailia, Egypt

Location

Related Publications (7)

• 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.

  PMID: 37433927 BACKGROUND

• 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.

  PMID: 33162115 BACKGROUND

• 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.

  PMID: 34803278 BACKGROUND

• 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.

  PMID: 23522533 BACKGROUND

• 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.

  PMID: 29121393 BACKGROUND

• 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.

  PMID: 31483863 BACKGROUND

• 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.

  PMID: 30993696 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Inflammation

Interventions

Edetic Acid; Etidronic Acid; Clodronic Acid; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Dalia Fayyad

  Professor of endodontics, faculty of dentistry, Suez Canal University

  STUDY DIRECTOR

• Dalia Abdallah

  Associate Professor of endodontics, faculty of dentistry, Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer of endodontics

Model Details: 5 groups with different treatment protocols to assess two parameters

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: August 11, 2025
• Study Start: August 20, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)