Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF

NCT02801552 | Completed DMC

• 1 other identifier: JS14031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.

Conditions

Periapical Periodontitis; Tooth Diseases; Stomatognathic Diseases

Keywords

regenerative endodontic treatment; platelet-rich fibrin; Immature permanent tooth; apical periodontitis

Outcome Measures

Primary Outcomes (1)

• Evidence of periapical healing

  12 months

Secondary Outcomes (2)

• Evidence of root development

  24 months

• Evidence of pulp sensibility

  24 months

Study Arms (2)

Regenerative Endodontic Procedure + PRF

EXPERIMENTAL

Visit 1: root canal dressing with triple antibiotic paste. Visit 2: a 5 ml sample of whole blood was drawn intravenously from the patient's forearm. The blood sample is centrifuged at 400 g for 10 min. The prepared PRF membrane is cut into segments, the fragments are placed into the canal space. The coronal is sealed mineral trioxide aggregate and composite resin.

Device: PRF

Regenerative Endodontic Procedure

NO INTERVENTION

Regenerative Endodontic Procedure Visit 1: root canal dressing with triple antibiotic paste. Visit 2: Blood clot formation is induced in the root canal after disinfection. No PRF was used in this group. Then the canal access is sealed with mineral trioxide aggregate and composite resin.

Interventions

PRF DEVICE

Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.

Also known as: mineral trioxide aggregate

Regenerative Endodontic Procedure + PRF

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between 6 and 18 years of age
• Provision of Informed Consent
• Cooperative in the dental chair
• Permanent immature teeth with apical periodontitis and incomplete root development

You may not qualify if:

• Have a medical history that may complicate treatment
• Unlikely to be able to comply with the study procedures

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

School and Hospital of Stomatology, Fujian Medical University

Fuzhou, Fujian, 350002, China

Location

MeSH Terms

Conditions

Periapical Periodontitis; Tooth Diseases; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Xiaojing Huang, PhD

  School and Hospital of Stomatology, Fujian Medical University

  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: DDS, PhD, Professor

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 16, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: February 1, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)