Examining the Effect of Different Filling Techniques on Healing in Lesional Teeth

NCT06384014 | Completed

• 1 other identifier: 2024/56
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. If there is no healing in the periradicular tissues after non-surgical endodontic treatment or if retreatment becomes impossible, surgical endodontic treatment is required. Apical resection is a surgical technique that involves removing the root tip of the tooth and closing the apical portion of the root canal system. An ideal retrograde filling material should be non-toxic, non-carcinogenic and biocompatible. It must also have dimensional stability and sealing properties. Amalgam, glass ionomer cements, and zinc oxide-eugenol based materials have been used for root end fillings in periapical surgery, but the desired success was not achieved. Today, Mineral Trioxide Aggregate (MTA) is preferred as a retrograde filling material due to its superior sealing properties, ability to harden in the presence of blood and moisture, antibacterial effects, biocompatibility and radiopacity. In the researchers' study, the effect of apical resection after orthograde canal filling and retrograde canal filling during apical resection on postoperative recovery will be compared. In both canal filling techniques, Sure-Seal Root MTA (Sure Dent Corporation-Korea) will be used as the filling material. Sure-Seal Root MTA is a calcium silicate based paste that is typically pre-mixed and ready to apply, exhibits excellent physical properties and does not show shrinkage during the curing process. As the manufacturer states, it is hydrophilic, biocompatible, has ideal setting and working time. Our faculty has piezosurgical ultrasonics (Mectron ®, Grassobbio BG, Italy). After the root tip resection is performed, the retrograde cavity will be prepared with Woodpecker ultrasonic tips (Guilin, China) compatible with this device. In our study using these materials and devices, a comparative analysis of the effects of different canal filling techniques on lesion healing and improvement in clinical symptoms will be made.

Conditions

Apical Cyst

Outcome Measures

Primary Outcomes (1)

• Comparison of lesion healing rate after apical resection using different root canal filling techniques

  lesion healing rate

  2 years

Study Arms (2)

Retrograde canal filling technique

ACTIVE COMPARATOR

Apical resection application after retrograde root canal filling

Device: retrograde and orthograde root canal filling

Orthograde canal filling technique

ACTIVE COMPARATOR

Apical resection application after orthograde root canal filling

Device: retrograde and orthograde root canal filling

Interventions

retrograde and orthograde root canal filling DEVICE

Apical resection application after root canal filling

Orthograde canal filling technique; Retrograde canal filling technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged between 18 and 65 years with persistent symptomatic apical pathology, characterized by pain on biting and/or percussion sensitivity, who provided written informed consent for the surgical procedure and follow-up examinations.
• \. Patients with a non-contributory medical history, classified as American Society of Anesthesiologists (ASA) Class I or II.
• \. Single-rooted anterior teeth with true endodontic lesions classified as Type B or C according to Kim and Kratchman's classification (Table 1).1 4. Single-rooted anterior teeth without significant canal calcification or obliteration, significant root curvature, or anatomical abnormalities.
• \. Teeth deemed restorable with sufficient remaining coronal structure to support a definitive restoration.

You may not qualify if:

• Patients with systemic diseases that contraindicate surgical procedures (e.g., uncontrolled diabetes, coagulation disorders, immunosuppression).
• Patients taking medications that may affect bone metabolism or healing (e.g., bisphosphonates, corticosteroids, anticoagulants).
• Pregnant or breastfeeding patients.
• Teeth with vertical root fractures, perforations, or external root resorption.
• Teeth with insufficient bone support or an unfavorable crown-to-root ratio as determined by clinical and radiographic assessment.
• Patients who declined follow-up participation or were unable to commit to the scheduled follow-up examinations.
• Teeth in which orthograde MTA obturation could not be completed intraoperatively due to anatomical limitations were to be excluded from analysis; however, no such cases were encountered in this trial.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Üniversitesi Diş Hekimliği Fakültesi

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radicular Cyst

Condition Hierarchy (Ancestors)

Periodontal Cyst; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Periapical Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• ERASLAN AKYÜZ

  BAŞ ARAŞTIRMACI

  PRINCIPAL INVESTIGATOR

• TOPÇUOĞLU

  YÜRÜTÜCÜ

  STUDY DIRECTOR

• ÖZDEMİR

  YARDIMCI ARAŞTIRMACI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: İki farklı grupta farklı kanal dolum teknikleri uygulandıktan sonra apikal rezeksiyon yapılarak lezyon iyileşmesinin değerlendirilmesi

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 25, 2024
• Study Start: May 8, 2024
• Primary Completion: August 5, 2026
• Study Completion: August 25, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

TU (1)