The Effect of Using Different Scaffolds in Retreated Teeth on The Clinical and Radiological Success of Regenerative Endodontic Treatment

NCT07721051 | Not Yet Recruiting

• 1 other identifier: 2026/08-2026.06.25
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical study aims to compare the clinical and radiographic outcomes of four different scaffolds used in regenerative endodontic treatment of previously root canal-treated permanent teeth requiring retreatment. Participants will be randomly assigned to one of four groups based on the scaffold used: induced blood clot, injectable platelet-rich fibrin (i-PRF), advanced platelet-rich fibrin (A-PRF), or advanced platelet-rich fibrin plus (A-PRF+). All participants will receive the same root canal disinfection and restorative procedures, with the scaffold type differing between the groups. Participants will be evaluated clinically and radiographically at 3, 6, and 12 months after treatment. The study will compare the groups in terms of the resolution of clinical signs and symptoms and changes observed on radiographic and cone-beam computed tomography images.

Conditions

PRF; i-PRF; Retreatment; A-PRF; A-PRF Plus; Endodontics; Regenerative Endodontic Procedures

Keywords

Regenerative endodontic procedures; retreatment; A-PRF; A-PRF plus; i-PRF

Outcome Measures

Primary Outcomes (1)

• Proportion of Teeth Achieving Clinical and Radiographic Success at 12 Months

  Clinical and radiographic success will be assessed as a composite binary outcome for each treated tooth at the 12-month follow-up. A tooth will be classified as successful if both clinical and radiographic success criteria are met. Clinical success will be defined as the absence of spontaneous pain, tenderness to percussion, tenderness to palpation, swelling, sinus tract, and pathological mobility. Radiographic success will be defined as reduction or complete resolution of the baseline periapical lesion without the development of a new periapical lesion. The outcome will be reported as the proportion of teeth achieving clinical and radiographic success at 12 months.

  12 months after treatment

Secondary Outcomes (3)

• CBCT-Based Change in Aggregate Periapical Lesion Size From Baseline to 12 Months

  From baseline to 12 months after treatment

• CBCT-Based Change in Mean Dentinal Wall Thickness From Baseline to 12 Months

  From baseline to 12 months after treatment

• CBCT-Based Change in Root Canal Volume From Baseline to 12 Months

  From baseline to 12 months after treatment

Study Arms (4)

Blood clot group

Bleeding will be induced by removing the apical opening with sterile Type K files to ensure the canal fills with blood. The blood clot induced apically will be used as the scaffold material.

i-PRF group

10 cc of venous blood drawn from the patient's antecubital vein will be centrifuged at 700 rpm for 3 minutes. The yellow layer on top will be drawn up with a syringe and injected into the canal. i-PRF will be used as the scaffold material.

A-PRF group

The 10 cc of venous blood obtained as in Group 2 will be centrifuged at 1500 rpm for 14 minutes. The yellow layer on top will be removed from the tube and applied into the canal using sterile applicators. A-PRF will be used as the scaffold material.

A-PRF+ group

As in Group 2, 10 cc of venous blood will be centrifuged at 1300 rpm for 8 minutes. The yellow layer on top will be removed from the tube and applied into the canal using sterile pluggers. A-PRF+ will be used as the scaffold material.

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will include patients aged 16-40 with single-canal, closed-apical permanent teeth who presented to the Department of Endodontics at the Faculty of Dentistry, Kırıkkale University, for endodontic retreatment.

You may qualify if:

• Patients aged 16-40 who are systemically healthy
• Patients who have a permanent tooth with a single root canal and fully developed root that requires retreatment
• Patients who may or may not have periapical radiolucency

You may not qualify if:

• Patients who require antibiotic prophylaxis
• Patients with systemic conditions such as diabetes or hematological disorders
• Patients who have taken antibiotics, anti-inflammatory medications, and/or antidepressants within the past three weeks
• Patients who are pregnant or suspect they may be pregnant during treatment
• Patients with heavy plaque and tartar buildup on their teeth
• Patients with redness and bleeding of the gums
• Patients with severe gingivitis, generalized periodontitis, or a periodontal pocket depth of more than 3 mm
• Patients with internal or external root resorption
• Patients for whom complete isolation with a rubber dam cannot be achieved
• Patients with an open, immature root apex
• Patients with horizontal or vertical fractures
• Patients with teeth having multiple roots or root canals

Sponsors & Collaborators

• Kırıkkale University: lead

Central Study Contacts

ALİ ERDEMİR, Professor

CONTACT

+905325650065; erdemirali@hotmail.com

Sara NAJJARİ HAGH

CONTACT

+905525981520; saranajjari1998@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07