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

NCT07119619 | Completed

• 2 other identifiers: 2022/64TDH-2023-3161
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Regenerative Endodontics

Keywords

Bllod clot; Chitosan; PRF; Regenerative endodontics

Outcome Measures

Primary Outcomes (2)

• Radiographic measurements of teeth treated with regenerative endodontic treatment

  Root length and thickness (millimeters)

  Baseline and through study completion, an average of 18 months

• Radiographic measurements of teeth treated with regenerative endodontic treatment

  Evaluation of root maturation (Cvek score; with a minimum of 1 and a maximum of 5, higher scores mean a better result)

  Baseline and through study completion, an average of 18 months

Secondary Outcomes (1)

• Radiographic measurements of teeth treated with regenerative endodontic treatment

  Baseline and through study completion, an average of 18 months

Study Arms (3)

Chitosan

OTHER

Procedure: Regenerative Endodontic Treatment Using a Chitosan as a Scaffold

Platelet-rich fibrin

OTHER

Procedure: Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold

Blood clot

OTHER

Procedure: Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold

Interventions

Regenerative Endodontic Treatment Using a Blood Clot as a Scaffold PROCEDURE

During 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.

Blood clot

Regenerative Endodontic Treatment Using a Chitosan as a Scaffold PROCEDURE

During 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.

Chitosan

Regenerative Endodontic Treatment Using a Platelet Rich Fibrin as a Scaffold PROCEDURE

During 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.

Platelet-rich fibrin

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient Selection Criteria
• Being between the ages of 6-14
• Not having any systemic disease
• Not using any regular medication
• Not having any detected allergies
• The patient must be able to cooperate to the extent that the treatment can be applied healthily
• The patient's guardian must agree to participate in the study
• Selection Criteria of Teeth • Restorable necrotic immature first and second permanent mandibular molars with two roots and a root development stage of 3 or 4 according to Cvek's classification

You may not qualify if:

• Failure to meet the patient and tooth selection criteria mentioned above

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Publications (2)

• Cehreli ZC, Isbitiren B, Sara S, Erbas G. Regenerative endodontic treatment (revascularization) of immature necrotic molars medicated with calcium hydroxide: a case series. J Endod. 2011 Sep;37(9):1327-30. doi: 10.1016/j.joen.2011.05.033. Epub 2011 Jul 13.

  PMID: 21846559 BACKGROUND

• Ulusoy AT, Turedi I, Cimen M, Cehreli ZC. Evaluation of Blood Clot, Platelet-rich Plasma, Platelet-rich Fibrin, and Platelet Pellet as Scaffolds in Regenerative Endodontic Treatment: A Prospective Randomized Trial. J Endod. 2019 May;45(5):560-566. doi: 10.1016/j.joen.2019.02.002. Epub 2019 Mar 30.

  PMID: 30935618 BACKGROUND

Study Officials

• Beyza Sandal

  Derince Oral and Dental Health Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: August 13, 2025
• Study Start: February 10, 2022
• Primary Completion: March 19, 2024
• Study Completion: August 20, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)