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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)

Primary Purpose

Periapical Periodontitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
injectable platelet rich fibrin augmented with Vitamin C
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring iprf, iprf with AA, periapical lesion

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Facility of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

injectable platelet rich fibrin with Vitamin C

Injectable platelet rich fibrin alone

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2022
Last Updated
October 14, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05585359
Brief Title
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)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
iprf, iprf with AA, periapical lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Randomized controlled blinding trail
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
injectable platelet rich fibrin with Vitamin C
Arm Type
Experimental
Arm Description
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.
Arm Title
Injectable platelet rich fibrin alone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
injectable platelet rich fibrin augmented with Vitamin C
Intervention Description
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
Primary Outcome Measure Information:
Title
Healing of periapical lesion
Description
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
Time Frame
1 year follow up
Secondary Outcome Measure Information:
Title
postoperative pain
Description
postoperative pain will be assessed at 6, 12, 24, 48,72 hours and 1 week from the second visit using numerical pain scale
Time Frame
1 week

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Adults with an age range of 18-45 years old
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wesam osama
Phone
01005540821
Email
wessam_osama@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesam Osama, assistant lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facility of Dentistry, Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wesam osama, assistant lecturer
Phone
0100540821
Email
wessam_osama@dentisrty.cu.edu.eg

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Learn more about this 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)

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