Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing

NCT06386991 | Recruiting Phase 4

• 1 other identifier: 2024/206
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year.

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (1)

• Determining and recording pain levels on the pain scale between treatment sessions

  Evaluations close to 100 on the postoperative pain scale indicate that the severity of pain increases. Evaluations close to 0 indicate that the severity of pain has decreased.

  2 weeks

Secondary Outcomes (1)

• In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography.

  2 years

Study Arms (3)

Ethylenediamine tetraacetic acid (EDTA)

ACTIVE COMPARATOR

Regenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and Ethylenediamine tetraacetic acid (EDTA)will be used when disinfecting root canals. (GROUP 1)

Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments

CITRIC ACID (MONO/ANH)

ACTIVE COMPARATOR

Regenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and CITRIC ACID (MONO/ANH) be used when disinfecting root canals. (GROUP 2)

Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments

ETİDRONİC ACID (HEBP)

ACTIVE COMPARATOR

Regenerative endodontic treatments require the use of irrigation solutions to break down inorganic and organic tissue residues in the root canals. Sodium hypochlorite (NaOCl) and ETİDRONİC ACID (HEBP) be used when disinfecting root canals. (GROUP 3)

Other: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments

Interventions

Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments OTHER

Regenerative endodontic treatment using different irrigation solutions

CITRIC ACID (MONO/ANH); ETİDRONİC ACID (HEBP); Ethylenediamine tetraacetic acid (EDTA)

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Teeth with apical periodontitis
• Teeth for which prosthetic restoration is not planned
• Patients between the ages of 8-15 who do not have any significant health problems
• Patients who are not accompanied by periodontal problems and have good oral hygiene

You may not qualify if:

• Severely damaged teeth
• If the tooth has previously undergone root canal treatment.
• Use of antibiotics, anti-inflammatory and painkillers in the last two weeks

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Üniversitesi Diş Hekimliği Fakültesi

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Akyuz IE, Eminsoy Avci AT, Ustun Y, Kolcakoglu KS, Kizilci E. Evaluation of the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic molar teeth with open apex on postoperative pain- randomized clinical trial. Clin Oral Investig. 2025 Jan 16;29(1):66. doi: 10.1007/s00784-025-06153-3.

  PMID: 39815035 DERIVED

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Edetic Acid; Citric Acid; Etidronic Acid

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Citrates; Tricarboxylic Acids; Diphosphonates; Organophosphonates; Organophosphorus Compounds

Study Officials

• ERASLAN AKYÜZ

  BAŞ ARAŞTIRMACI

  PRINCIPAL INVESTIGATOR

• ÜSTÜN

  YÜRÜTÜCÜ

  STUDY DIRECTOR

• EMİNSOY AVCI

  YARDIMCI ARAŞTIRMACI

  STUDY CHAIR

• SOLAK KOLÇAKOĞLU

  YARDIMCI ARAŞTIRMACI

  STUDY CHAIR

• KIZILCI

  YARDIMCI ARAŞTIRMACI

  STUDY CHAIR

Central Study Contacts

ERASLAN AKYÜZ

CONTACT

4447138; ipekemamak@hotmail.com

ÜSTÜN

CONTACT

4447138; yustun@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 26, 2024
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

TU (1)