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)

NCT05585359 | Unknown

• 1 other identifier: 5-6-1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Periapical Periodontitis

Keywords

iprf; iprf with AA; periapical lesion

Outcome Measures

Primary Outcomes (1)

• Healing of periapical lesion

  Healing 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

  1 year follow up

Secondary Outcomes (1)

• postoperative pain

  1 week

Study Arms (2)

injectable platelet rich fibrin with Vitamin C

EXPERIMENTAL

Injectable platelet rich fibrin: 10-mL sample 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 at 700 rpm for 3 minutes (60×g) . After centrifugation, the upper yellow fluid liquid (i-PRF) will be collected as close as possible to the layer of red cells the will be mixed with 250 micromole of Vitamin C.

Other: injectable platelet rich fibrin augmented with Vitamin C

Injectable platelet rich fibrin alone

ACTIVE COMPARATOR

injectable platelet rich fibrin: 10-mL sample 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 at 700 rpm for 3 minutes (60×g) . After centrifugation, the upper yellow fluid liquid (i-PRF) will be collected as close as possible to the layer of red cells

Other: injectable platelet rich fibrin augmented with Vitamin C

Interventions

injectable platelet rich fibrin augmented with Vitamin C OTHER

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

Injectable platelet rich fibrin alone; injectable platelet rich fibrin with Vitamin C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Adults with an age range of 18-45 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Facility of Dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (1)

• 1-Tervit, C. et al. (2009) 'Proportion of Healed Teeth With Apical Periodontitis Medicated With Two Percent Chlorhexidine Gluconate Liquid: A Case-Series Study', Journal of Endodontics, 35(9), pp. 1182-1185. 2- Trope, M. (2003) The vital tooth-its importance in the study and practice of endodontics. Endod Topics 2003; 5:1-1. 3- Kim, S.G. et al. (2018) 'Regenerative endodontics: a comprehensive review', International Endodontic Journal. Blackwell Publishing Ltd, pp. 1367-1388. 4- Adnan, S. and Ullah, R. (2018) 'Top-cited Articles in Regenerative Endodontics: A Bibliometric Analysis', Journal of Endodontics. Elsevier Inc., pp. 1650-1664. 5- Kahler, B. and Lin, L.M. (2017) 'A REVIEW OF REGENERATIVE ENDODONTICS: CURRENT PROTOCOLS AND FUTURE DIRECTIONS', Journal of Istanbul University Faculty of Dentistry, 51(0). 6- Ibrahim, lamiaa, tawfik, mohamed and abu naeem, fatma (2021) "Evaluation of The Periapical Healing Following Pulp Revascularization Using Injectable PRF VS nonsurgical Root Canal Treatment in Mature Permanent Teeth with periapical periodontitis. A Clinical Study," Egyptian Dental Journal, 67(3), pp. 2663-2672.

  BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Wesam Osama, assistant lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wesam osama

CONTACT

01005540821; wessam_osama@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at Misr University for Science and Technology

Model Details: Parallel Randomized controlled blinding trail

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

EG (1)