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Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing

NCT ID: NCT06386991

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Regenerative endodontic treatment using different irrigation solutions

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Regenerative endodontic treatment using different irrigation solutions

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Regenerative endodontic treatment using different irrigation solutions

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ipek Eraslan Akyuz

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ERASLAN AKYÜZ

Role: PRINCIPAL_INVESTIGATOR

BAŞ ARAŞTIRMACI

ÜSTÜN

Role: STUDY_DIRECTOR

YÜRÜTÜCÜ

EMİNSOY AVCI

Role: STUDY_CHAIR

YARDIMCI ARAŞTIRMACI

SOLAK KOLÇAKOĞLU

Role: STUDY_CHAIR

YARDIMCI ARAŞTIRMACI

KIZILCI

Role: STUDY_CHAIR

YARDIMCI ARAŞTIRMACI

Locations

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Erciyes Üniversitesi Diş Hekimliği Fakültesi

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ERASLAN AKYÜZ

Role: CONTACT

[email protected]
4447138 ext. 0352

ÜSTÜN

Role: CONTACT

[email protected]
4447138 ext. 0352

Facility Contacts

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ERASLAN AKYÜZ

Role: primary

[email protected]
4447138 ext. 0352

ÜSTÜN

Role: backup

[email protected]
4447138 ext. 0352

References

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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.

Reference Type DERIVED
PMID: 39815035 (View on PubMed)

Other Identifiers

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2024/206

Identifier Type: -

Identifier Source: org_study_id

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