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Maximum Occlusal Bite Force of Necrotic Permanent Teeth Treated by Regenerative Technique: Randomized Clinical Trial
Sponsor: Lama Awawdeh
Summary
Further investigation is warranted to ascertain whether the regaining of sensibility and nerve function in regenerated teeth leads to the re-establishment of the proprioceptive protective mechanism inherent in vital teeth. Hence, the primary objective of this prospective randomized clinical trial is to conduct a comparative analysis of the potential effects of pulp revascularization in comparison to conventional endodontic treatments, either RCT or apexification on the Maximum occlusal bite force (MBF) in both immature and mature necrotic permanent teeth. Methods: Upon satisfying the predetermined criteria for inclusion, a total of 184 patients will be recruited for this prospective clinical trial. The study will consist of two groups, specifically Group I: Mature teeth and Group II: Immature teeth, with a sample size of 92 participants in each group. The participants will be assigned randomly to one of the two treatment modalities per group. Group I: will undergo treatment with RCT/revascularization, while Group II will receive MTA plug/revascularization encompassing both mature (n=92) and immature teeth (n=92). MBF will be measured on the selected necrotic teeth prior to clinical intervention, this measurement will be conducted using a portable occlusal force gauge (GM10). Following the completion of therapy, MBF measurements will be repeated at 6 and 12 months to assess long-term outcomes. Subsequently, the collected data will undergo comprehensive analysis.
Official title: Maximum Occlusal Bite Force of Necrotic Mature and Immature Permanent Teeth pre-and Post-treatment With the Available Treatment Modalities: Randomized Clinical Trial
Key Details
Gender
All
Age Range
10 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-12-20
Completion Date
2027-12
Last Updated
2025-04-18
Healthy Volunteers
No
Interventions
measurement of maximum bite force using bite fork
using bite fork the bite force will be recorded for all teeth preoperative and post operative
conventional root canal treatment
General principles of conventional endodontic treatment will be applied in all cases, such as the administration of an appropriate local anaesthetic and rubber dam isolation. access and cleaning and shaping using rotary files and obturation. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph
pulp revascularization by induced bleeding
Regeneration procedures will be conducted in two appointments, adhering to the 'Clinical Considerations for a Regenerative Procedure' proposed by the American Association of Endodontists (AAE) in 2021. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph
MTA apexification
MTA apical plug will be randomly applied to teeth with open apex
Locations (1)
Postgraduate Dental Clinic Jordan University of Science and Technology
Irbid, Jordan