Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing

April 24, 2024 updated by: Ipek Eraslan Akyuz, TC Erciyes University

Evaluation of the Effects of Different Irrigation Solutions Used in Regenerative Endodontic Treatment of Lower Molars With Open Necrotic Apexes on Postoperative Pain and Lesion Healing

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Root canal treatment is a treatment method applied to milk and permanent teeth. The inflamed and necrotic pulp where the root canal is located is cleaned, debrided chemo-mechanically, and finally filled hermetically with a biocompatible material. Necrotic immature teeth lose their restorative and defensive abilities. Since the root canal walls of these teeth are thin and weak, regenerative endodontic procedures are applied more frequently in the treatment of immature teeth to ensure root development and to restore the vitality of the pulp tissue. 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.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Recruiting
        • Erciyes Üniversitesi Diş Hekimliği Fakültesi
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:• Molars with open apex

  • 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

Exclusion Criteria:• People with systemic disease and allergic reactions

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ethylenediamine tetraacetic acid (EDTA)
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
Regenerative endodontic treatment using different irrigation solutions
Active Comparator: CITRIC ACID (MONO/ANH)
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
Regenerative endodontic treatment using different irrigation solutions
Active Comparator: ETİDRONİC ACID (HEBP)
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
Regenerative endodontic treatment using different irrigation solutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining and recording pain levels on the pain scale between treatment sessions
Time Frame: 2 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography.
Time Frame: 2 years
Evaluations close to 100 on the scale following lesion healing indicate that the lesion size has increased. Evaluations close to 0 indicate that the lesion size has decreased.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: ERASLAN AKYÜZ, BAŞ ARAŞTIRMACI
  • Study Director: ÜSTÜN, YÜRÜTÜCÜ
  • Study Chair: EMİNSOY AVCI, YARDIMCI ARAŞTIRMACI
  • Study Chair: SOLAK KOLÇAKOĞLU, YARDIMCI ARAŞTIRMACI
  • Study Chair: KIZILCI, YARDIMCI ARAŞTIRMACI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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