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Clinical Trials in Turkey / NCT07583004
Active, not recruiting Not applicable

Effect of Different Root Canal Preparation Sizes and Remaining Tooth Structure on the Survival of Endodontically Treated Mandibular Molars

NCT07583004 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-01-01
Last updated
2026-05-13

Condition(s) studied

Periapical HealingRestoration Survival

Investigational drug(s) / intervention(s)

ProTaper GoldTruNatomy file system

ProTaper Gold: Patients will be treated endodontically using Protaper Gold rotary file system

TruNatomy file system: TruNatomy file system

Study summary

Teeth that have undergone endodontic treatment are biomechanically weakened compared to vital teeth due to factors such as extensive carious lesions, previous restorations, loss of marginal ridges and pericervical dentin, and hard tissue removal during access cavity preparation and root canal instrumentation. Additionally, the quantity and quality of the remaining coronal tooth structure, the presence of marginal ridges, the ferrule effect, and the integrity of pericervical dentin directly influence both fracture resistance and the long-term success of restorations.

Following endodontic access cavity preparation, the fracture resistance of the tooth decreases by approximately 5%. This reduction increases to around 20-30% in the case of unilateral marginal ridge loss (mesio-occlusal \[MO\] or disto-occlusal \[DO\] cavities), and can reach up to 63% when both marginal ridges are lost (mesio-occluso-distal \[MOD\] cavities). This condition may lead to cusp deflection under occlusal forces and, particularly in the absence of appropriate post-endodontic restoration, may result in failures such as vertical root fractures.

It has been reported that, after caries removal and access cavity preparation, the amount of remaining sound coronal tooth structure may play an important role in determining the extent of mechanical preparation during treatment. The goal of mechanical preparation of the root canal system is to remove infected dentin and biofilm as much as possible and to create a continuously tapered canal shape that allows effective delivery of irrigants to the apical region. Although conventional preparation principles may provide higher levels of disinfection, they have been associated with reduced tooth strength, particularly due to the loss of resistance in the pericervical area. This has led to the development of more conservative root canal preparation strategies using instruments with smaller apical sizes and tapers.

Previous studies investigating the relationship between preparation size and fracture resistance have shown considerable heterogeneity. Moreover, the predominantly in vitro nature of these studies limits their ability to accurately simulate clinical conditions. In addition, factors such as the amount of remaining tooth structure after treatment and the effectiveness of the final restoration are often overlooked. Therefore, it is important to support in vitro findings with clinical studies. To date, there is no long-term clinical study in the literature evaluating the combined effects of conventional and conservative preparation strategies on clinical survival and periodontal health in teeth with varying degrees of coronal tissue loss.

The aim of this study is to clinically and radiographically evaluate the survival of mandibular molars with different amounts of remaining tooth structure (O, MO/DO, and MOD) following conventional and conservative root canal preparation. The null hypothesis is that different preparation strategies and the amount of remaining tooth structure have a similar effect on tooth survival.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: Patients with mandibular molar teeth diagnosed with symptomatic irreversible pulpitis according to the pulp disease classification recommended by the American Association of Endodontists Patients with active caries in the relevant tooth that would create O, MO/OD, or MOD type cavitations. Patients with periodontally healthy teeth (Grade I mobility or \<4 mm pocket depth). Patients with no systemic diseases (ASA I or II). Patients between the ages of 18-60. Teeth where rubber dam isolation could be achieved. Cases where the remaining sound tooth structure allowed for a direct composite restoration. Exclusion Criteria:Teeth with non-vital pulp and/or observable periapical lesions. Teeth that were not periodontally healthy (Grade II/III mobility or \>3 mm pocket depth). Teeth with complex root canal anatomy (curved canals, C-shaped canals, calcified/obstructed canals, etc.). Patients with systemic diseases, or those who were pregnant or breastfeeding. Patients with parafunctional habits such as bruxism. Teeth without an opposing tooth in the maxillary arch. Teeth that could not be restored due to advanced crown destruction or those with existing prosthetic restorations. Patients whose endodontic treatment had already been initiated elsewhere. Patients who experienced complications during the treatment procedure. \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Unişversity of Health Sciences Ankara Turkey (Türkiye)

More Saglik Bilimleri Universitesi trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07583004 on ClinicalTrials.gov ↗ ← All trials in Turkey