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Effect of Injectable Platelet Rich Fibrin Augmented With Vitamin C Compared to Injectable Platelet Rich Fibrin Alone on Healing of Necrotic Mature Single Rooted Teeth With Chronic Peri-apical Periodontitis Following Regenerative Endodontics (A Randomized Controlled Trial)

Effect of Injectable Platelet Rich Fibrin Augmented With Vitamin C Compared to Injectable Platelet Rich Fibrin Alone on Healing of Necrotic Mature Single Rooted Teeth With Chronic Peri-apical Periodontitis Following Regenerative Endodontics (A Randomized Controlled Trial)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05585359
Enrollment
28
Registered
2022-10-18
Start date
2023-04-01
Completion date
2025-12-01
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Periodontitis

Keywords

iprf, iprf with AA, periapical lesion

Brief summary

The purpose of the study is to investigate the effect of injectable platelet rich fibrin augmented with Vitamin C (ascorbic acid) in healing of chronic peri-apical lesion, by assessing it radiographically 2dimensionally and 3 dimensionally

Detailed description

all patients will be informed about the study through informed constant that will describe the natural of the study beside the potential risks of it. After accurate diagnosis clinically and radiographically, patients who will meet the eligibility criteria will be randomized. The standardized operating procedure of regenerative therapy requires two treatment visits. During the first appointment, infection is controlled and inflammation is relieved. Regenerative procedure and revascularization are accomplished during the second appointment. At the first visit, perioperative CBCT will be taken, access cavity with full mechanical preparation will be accomplished followed by application of double biotics paste for 3 weeks. At the second appointment the intra-canal medicaments will be removed then 10 ml of blood of whole venous blood will be drawn from the patient's forearm and transferred into two plain plastic test tubes without an anticoagulant and will centrifuge immediately u at 700 rpm for 3 minutes then liquid platelet rich fibrin layer will be taken with plastic syringe and according to the group of the patient that will be assigned, the patient will receive either the iprf alone or to be mix with Vitamin C and injected inside the canal. Collagen membrane will be placed over the iprf or iprf with Vitamin C then the tooth will be restored with resin filling material, the patients will be followed every 3 months for 1 year, at every follow up periapical radiograph will be taken with standardized bite block and after 1 year CBCT will aslo be taken with same parameter of the perioperative one t be compared and asses the reduction of the periapical lesions

Interventions

OTHERinjectable platelet rich fibrin augmented with Vitamin C

According to the amount of the injectable platelet rich fibrin that will be obtained after the centrifugation of blood, the amount of Vitamin C will be calculated to be; for each 1 ml of injectable platelet rich fibrin, 250 μg of Vitamin C will be mixed with the i-PRF and injected inside the canals using a plastic syringe with a 25-gauge needle that was placed 1mm short of the working length and will be withdrawn gradually while injecting till reaching the canal orifice

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The investigator will not be blinded due to the natural of the intervention and control which require blood withdrawal from the patient or to be mixed with the Vitamin C. * The patients and the outcome assessors are blinded to the intervention. * The patients will not be informed which technique of treatment will be used. * Data analyst will be blinded, he/she will receive data excel sheets with group A and group B

Intervention model description

Parallel Randomized controlled blinding trail

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Patients were enrolled to the present study if they fulfilled the inclusion criteria of being fit and healthy (ASA I and II). * Adults with an age range of 18-45 years old, with no sex predication. * Patients diagnosed with pulp necrosis in mature maxillary or mandibular anterior teeth with negative response to both cold and electrical pulp testing. * Associated with or without swelling /sinus tract. * Has radiographic evidence of periapical radiolucency

Exclusion criteria

Patients with medically compromised conditions (ASA III and IV). * Patients who are allergic to the drugs or pharmaceuticals used in the trial (mainly ciprofloxacin or metronidazole). * Patients with presence of periodontal pockets, pathological mobility, ankyloses, root fracture. * Patients with non-restorable teeth, teeth with pulp space needed for post cementation. * Teeth with previous root canal treatment, teeth with developmental anomalies, and teeth with external or internal resorption.

Design outcomes

Primary

MeasureTime frameDescription
Healing of periapical lesion1 year follow upHealing of periapical lesion will be assessed clinically normalcy including incidence of pain on percussion, swelling and sinus tract , aslo will be assed 2 dimensionally and 3 dimensionally using CBCT

Secondary

MeasureTime frameDescription
postoperative pain1 weekpostoperative pain will be assessed at 6, 12, 24, 48,72 hours and 1 week from the second visit using numerical pain scale

Countries

Egypt

Contacts

Primary Contactwesam osama
wessam_osama@dentistry.cu.edu.eg01005540821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026