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

NCT ID: NCT06384014

Last Updated: 2024-04-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Periapical or periradicular lesions are barriers that restrict microorganisms and prevent their spread to surrounding tissues; microorganisms cause periapical lesions, either primary or secondary. Apical infections, if left untreated, can follow two different paths: First, the infection can create a path inside or outside the mouth, causing the pus to drain out. Secondly, infection within the canal; It may reach the periapical tissues and create a cavity surrounded by polymorphonuclear leukocytes in the bone, leading to the formation of inflammatory radicular cysts.

Inflammatory radicular cysts (IRCs) are chronic lesions that occur after the development of periapical granulomas (PGs). PGs and IRCs are thought to follow pulp infections as an inflammatory process at the periapical level. Although both conditions, PG and IRC, are clinically diagnosed as apical periodontitis (AP), they differ significantly histopathologically.

The majority of apical cysts are asymptomatic and may develop insidiously by being discovered incidentally during a routine x-ray examination as a large periapical radiolucency covering the apex of one or more teeth. By confirming that the lesion is a granuloma or cyst, a more definitive diagnosis is reached by histopathological examination. Although conventional radiographic methods cannot be used for the definitive diagnosis of periapical cysts, larger round or oval, well-circumscribed radiolucent images around the apex of the tooth are considered to be cystic lesions.

When the infection in the canal is successfully treated, apical cysts can regress by the apoptosis mechanism in the root canal without the need for surgical intervention. Researchers stated that incorrect histopathological diagnosis in early studies created the false impression that radicular cysts were more common, and that this methodological error led to the illusion that most cystic lesions in the periapex area healed after non-surgical root canal treatment. In conclusion, the authors suggested that true cysts may be less likely to heal with nonsurgical root canal treatment due to their inherently self-sustaining properties and may require surgical intervention. Whether true cysts heal after non-surgical root canal treatment is still a major debate.

Different retrograde canal filling materials have been tried in the literature, but today, Mineral Trioxide Aggregate (MTA) is most commonly used because it is more biocompatible and has a periapical healing-inducing effect. MTA; It is the first restorative material that allows cementum development and provides regeneration in periodontal ligament cells. In addition, histological sections taken from the periapical region of teeth with retrograde canal filling with MTA often showed new cementum formation not only on the resection surface but also directly on the MTA. For this reason, MTA is called bioactive material. Properties of MTA such as biocompatibility, sealing, and the capacity to increase the regeneration of pulp and periradicular tissues; It has increased the diversity of dental usage areas and clinical success rates, and has become the focus of attention of clinicians with this innovative structure. In comparative studies on retrograde filling materials, MTA has demonstrated an excellent tissue response with almost no inflammatory component.

There are few studies in the literature comparing the effects of two different canal filling techniques (orthograde, retrograde), which are currently frequently used, on postoperative recovery. There is no study comparing the long-term postoperative radiographic and clinical improvement levels of using MTA with different application techniques in teeth with periapical lesions with an indication for apical resection. The purpose of researchers' planned study is to compare and evaluate the healing effect of orthograde MTA application followed by resection in teeth with large periapical lesions and retrograde MTA application during apical resection operation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Apical Cyst

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

İki farklı grupta farklı kanal dolum teknikleri uygulandıktan sonra apikal rezeksiyon yapılarak lezyon iyileşmesinin değerlendirilmesi
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Retrograde canal filling technique

Apical resection application after retrograde root canal filling

Group Type ACTIVE_COMPARATOR

retrograde and orthograde root canal filling

Intervention Type DEVICE

Apical resection application after root canal filling

Orthograde canal filling technique

Apical resection application after orthograde root canal filling

Group Type ACTIVE_COMPARATOR

retrograde and orthograde root canal filling

Intervention Type DEVICE

Apical resection application after root canal filling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

retrograde and orthograde root canal filling

Apical resection application after root canal filling

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy volunteers without systemic disease between the ages of 18 and 65
* Single-rooted teeth with periapical lesions larger than 1 cm
* Patients who do not have any contraindications for the surgical procedure.

Exclusion Criteria

* Individuals with systemic diseases and allergic reactions
* Pregnancy and breastfeeding
* Severely damaged teeth
* Patients with contraindications for surgical operation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ipek Eraslan Akyuz

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ERASLAN AKYÜZ

Role: PRINCIPAL_INVESTIGATOR

BAŞ ARAŞTIRMACI

TOPÇUOĞLU

Role: STUDY_DIRECTOR

YÜRÜTÜCÜ

ÖZDEMİR

Role: STUDY_CHAIR

YARDIMCI ARAŞTIRMACI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erciyes Üniversitesi Diş Hekimliği Fakültesi

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ERASLAN AKYÜZ

Role: CONTACT

4447138 ext. 0352

ÖZDEMİR

Role: CONTACT

4447138 ext. 0352

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ERASLAN AKYÜZ

Role: primary

4447138 ext. 0352

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024/56

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.