Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing

Endodontic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386991
• Other study ID #: 2024/206
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: TC Erciyes University
• Contact: ERASLAN AKYÜZ
• Phone: 4447138
• Email: ipekemamak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: January 1, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Turkey	Erciyes Üniversitesi Dis Hekimligi Fakültesi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography.	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