Clinical Trials Directory

Trials / Completed

CompletedNCT07119619

Clinical and Radiographic Outcomes of PRF, Chitosan, and Blood Clot in Regenerative Endodontics of Molars

Evaluation of the Clinical and Radiographic Success of Platelet-Rich Fibrin, Chitosan, and Blood Clot as Scaffolds in Regenerative Endodontic Treatment of Molars

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Inonu University · Academic / Other
Sex
All
Age
6 Years – 14 Years
Healthy volunteers
Accepted

Summary

This clinical trial aimed to evaluate the long-term effects of using chitosan, blood clots, and platelet-rich fibrin as scaffolds in regenerative endodontics on tooth development. The trial aimed to answer the following questions: Does chitosan shorten the duration of treatment for participants? Does chitosan promote root development? Which scaffold is most effective for root development? Which scaffold is more practical and effective to use in pediatric patients? Participants underwent regenerative endodontic treatment and were called to the clinic every six months for symptom assessment. Clinical and radiographic records were kept.

Detailed description

Regenerative endodontic treatments are biologically based procedures designed to physiologically replace damaged tooth structures, including the cells of the pulp-dentin complex. The aim of this treatment is to promote normal root development in immature permanent teeth with necrotic pulp.The primary goal of regenerative endodontics is to stimulate stem cells and encourage their division and proliferation to regenerate damaged tissue. However, a scaffold is essential for the survival of stem cells throughout the regeneration process. A key component of this process is the presence of a scaffold that allows stem cells from the apical papilla to adhere, proliferate, and differentiate. Blood clots and platelet-rich fibrin are frequently used as scaffolds in regenerative endodontics. However, research is ongoing to determine the appropriate scaffold for cases where these are not applicable.Researchers investigated an alternative scaffold for children who could not achieve apical bleeding or allow blood collection from the arm for PRF. Due to its biocompatibility, low cost, and broad-spectrum antibacterial activity, chitosan was included as the third group in this study. The immature necrotic molars to be treated were randomly divided into three groups. Regenerative endodontic treatment was performed using three different scaffolds: blood clot, PRF, and chitosan. The results were evaluated radiographically and clinically.

Conditions

Interventions

TypeNameDescription
PROCEDURERegenerative Endodontic Treatment Using a Blood Clot as a ScaffoldDuring the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material.The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points. Bleeding was induced by instrumentation with a K-type file, at 2 mm past the apical foramen, thus creating a blood clot within the canal. MTA was applied on the scaffold as capping material.
PROCEDURERegenerative Endodontic Treatment Using a Chitosan as a ScaffoldDuring the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material. The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points.Chitosan in gel form was placed into the root canal space with the help of an injector.MTA was applied on the scaffold as capping material.
PROCEDURERegenerative Endodontic Treatment Using a Platelet Rich Fibrin as a ScaffoldDuring the initial visit, the teeth were anesthetized using inferior alveolar block anesthesia. The endodontic access cavity was then opened. Each canal was irrigated with 2.5% NaOCl and saline. The canals were dried with paper points. Ca(OH)2 was placed in the canals with the objective of achieving an antimicrobial effect. After the application of root canal disinfectant, the opened cavity was sealed with a temporary filling material.The patient has been scheduled for a follow-up appointment within one to four weeks. During the second appointment, local anesthesia was performed using an anesthetic agent that did not contain a vasoconstrictor. The canals were irrigated with 17% EDTA and dried with paper points.Ten milliliters of venous blood was collected from the patient and immediately placed in a centrifuge at 3000 rpm for 10 minutes. The prepared PRF was placed in the canal space. MTA was applied on the scaffold as capping material.

Timeline

Start date
2022-02-10
Primary completion
2024-03-19
Completion
2024-08-20
First posted
2025-08-13
Last updated
2025-08-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07119619. Inclusion in this directory is not an endorsement.