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)

NCT ID: NCT05585359

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-12-01

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

Conditions

Periapical Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

injectable platelet rich fibrin with Vitamin C

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.

Group Type: EXPERIMENTAL

injectable platelet rich fibrin augmented with Vitamin C

Intervention Type: 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: 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

Group Type: ACTIVE_COMPARATOR

injectable platelet rich fibrin augmented with Vitamin C

Intervention Type: 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

Interventions

injectable 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Wesam Osama Hassan Soliman

Assistant lecturer at Misr University for Science and Technology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wesam Osama, assistant lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Facility of Dentistry, Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

wesam osama

Role: CONTACT

wessam_osama@dentistry.cu.edu.eg

01005540821

Facility Contacts

wesam osama, assistant lecturer

Role: primary

wessam_osama@dentisrty.cu.edu.eg

0100540821

References

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.

Reference Type: BACKGROUND

Other Identifiers

5-6-1

Identifier Type: -

Identifier Source: org_study_id