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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-40
SponsorKırıkkale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 4 trial groups
Group A: Blood clot group
Group B: i-PRF group
Group C: A-PRF group
Group D: A-PRF+ group

Trial outcomes

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.

Time frame
12 months after treatment

Secondary outcomes

1

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

Periapical lesion size will be assessed on cone-beam computed tomography images at baseline and at the 12-month follow-up. The mesiodistal, buccolingual, and vertical dimensions of the lesion will be measured in millimeters. These three linear measurements will be summed to obtain one aggregate periapical lesion size value for each tooth. The change in aggregate periapical lesion size from baseline to 12 months will be compared among the scaffold groups.

Time frame
From baseline to 12 months after treatment
2

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

Dentinal wall thickness will be measured in millimeters on cone-beam computed tomography images at baseline and at the 12-month follow-up. Measurements will be performed at predefined levels from the radiographic apex, and the mean of these measurements will be calculated to obtain one dentinal wall thickness value for each tooth. The change in mean dentinal wall thickness from baseline to 12 months will be compared among the scaffold groups.

Time frame
From baseline to 12 months after treatment
3

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

Root canal volume will be measured in cubic millimeters on cone-beam computed tomography images at baseline and at the 12-month follow-up using image analysis software. The change in root canal volume from baseline to 12 months will be compared among the scaffold groups.

Time frame
From baseline to 12 months after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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