Lesion Healing After Regenerative Endodontic Treatment

NCT06843850 | Completed

• 1 other identifier: 2024/302
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Endodontics involves various therapeutic interventions for diagnosing, preventing, and managing pulpal and periradicular pathologies. Root canal treatment, a widely performed procedure, involves removing necrotic pulp tissue and replacing it with a root-filling material, but it limits the tooth's immune defense and regenerative capacity. In immature permanent teeth, pulpal damage can lead to incomplete root formation, increasing the risk of fractures. To address these challenges, regenerative endodontic procedures (REPs) promote tissue regeneration within the root canal using tissue engineering principles. Despite high success rates, REPs lack a standardized irrigation protocol. Current guidelines recommend using 17% EDTA after low-concentration NaOCl to reduce cytotoxicity and release bioactive molecules. Citric acid has shown promise in in vitro studies as an alternative chelating agent, but direct comparisons with EDTA in clinical settings remain limited. This study aims to bridge this gap by evaluating the long-term effects of EDTA and citric acid on clinical symptoms and lesion healing in REPs.

Conditions

Apical Periodontitis

Keywords

irrigation solution; lesion healing; regenerative endodontics

Outcome Measures

Primary Outcomes (1)

• Comparison of the effects of different irrigation solutions used in regenerative endodontics on lesion healing using surveys

  1 year

Study Arms (2)

EDTA

EXPERIMENTAL

Device: regenerative endodontics

Citric acid

EXPERIMENTAL

Device: regenerative endodontics

Interventions

regenerative endodontics DEVICE

The effect of different irrigation solutions on lesion healing in regenerative endodontics will be compared.

Citric acid; EDTA

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The included patients were healthy (Category: American Society of Anesthesiologists class 1). This study included the necrotic, deeply carious mandibular molars of patients born between 2009 and 2015. Preoperative periapical films of the relevant teeth were evaluated, and teeth determined as Stages 2 and 3 according to the Cvek classification were included in the current study \[27\].

You may not qualify if:

• Patients were excluded if they had a systemic disease or were on systemic corticoste roid therapy, patients reported bruxism or clenching, took analgesics or other drugs that might alter their pain during the last 12 h preoperatively, or had a history of allergic reac tions to any of the medications or materials used. Patients with a tooth with severely curved root canals, vertical root fracture, coronal perforation, calcification or more signifi cant than Grade I mobility, or pocket depth greater than 5 mm were also excluded.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Regenerative Endodontics

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist dentist

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 25, 2025
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)