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Healing Potentiality Of Blood Clot ,S-PRF and A-PRF In Treatment Of Necrotic Mature Single Rooted Teeth With Chronic Peri-Apical Periodontitis

Primary Purpose

Healing Potentiality After Regeneration Using Standard PRF and Advanced PRF in Mature Necrotic Single Teeth

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Advanced Platelet Rich fibrin

About this trial

This is an interventional treatment trial for Healing Potentiality After Regeneration Using Standard PRF and Advanced PRF in Mature Necrotic Single Teeth

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Medically free patients who accept to participate in the study.
Age between 18-35 years old with no sex predilection.
Patients with good oral hygiene.
Patients with necrotic pulp in mandibular & maxillary single rooted permanent teeth with mature apex that Symptomatic or Asymptomatic , Doesn't respond positively with the electric pulp tester ,Associated with or without swelling /sinus tract, Has radiographic evidence of periapical radiolucency, Has a straight, non-curved root, Teeth with normal occlusal contact with the opposing teeth.

Exclusion Criteria:

Illiterate patient because they can't estimate the pain level on the pain scale (NRS).
Patients with systemic diseases or on systemic corticosteroids therapy because they have impaired healing and higher incidence of pain.
Pregnant women to avoid radiation exposure during the treatment which may be hazardous to the fetus and breasts from dental X-ray examinations shields.
Patients that have allergy to ciprofloxacin or metronidazole to avoid any allergic reaction after placement of bi-antibiotic paste as intra-canal medication.
Patients reporting bruxism or clenching because this induce more pressure on teeth and may initiate the post-operative pain in the treated tooth which is already have peri-apical inflammation
Teeth that, Have vertical root fracture, coronal perforation, and calcification, Are indicated for retreatment because they have lower success rate , Have pocket depth greater than 5mm,Need periodontal therapy , Non restorable , Hopeless tooth, patients that have T.M.J disorder

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Experimental

Arm Label

Blood Clot

Standard PRF

Advanced PRF

Arm Description

It is induced through apical foramen by penetrating the periapical area by stainless steel file size 30 to fill the root canal system by growth factors also to be considered as scaffold

Standard Platelet-rich fibrin will be prepared by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 3000 rpm for 10 min. After centrifugation, three layers will formed in the test tube-base layer of RBCs, top layer of a-cellular plasma, and a PRF clot in the middle. This clot will then pressed between two gauze pieces to form a membrane.

A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes

Outcomes

Primary Outcome Measures

healing Rate

standardized digital radiograph

Secondary Outcome Measures

Postoperative pain: NRS

using neumerical rationg scale NRS . from zero to 10 . zero = no pain 1 to 3 = mild 4-6 = moderate 7-10 = severe

sensitivty

using sensitivity tests

Full Information

NCT ID

NCT04606719

First Posted

October 25, 2020

Last Updated

November 2, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04606719

Brief Title

Healing Potentiality Of Blood Clot ,S-PRF and A-PRF In Treatment Of Necrotic Mature Single Rooted Teeth With Chronic Peri-Apical Periodontitis

Official Title

Healing Potentiality Of Blood Clot, S-PRF and A-PRF As Scaffold In Treatment Of Non-Vital Mature Single Rooted Teeth With Chronic Peri-Apical Periodontitis Following Regenerative Endodontic Therapy (Randomized Clinical Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2021 (Anticipated)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

September 1, 2023 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Earlier, it was believed that successful regeneration cannot be achieved once tooth has become infected. However, recent studies suggest that regenerative endodontics may in fact be possible in teeth with pulpal necrosis and periapical pathology. The primary goal in regenerative procedure is to eliminate clinical symptoms and resolve apical periodontitis. The blood clot acts as a scaffold, and the growth factors inside recruit stem cells, most likely from periapical papilla. But unfortunately, the erythrocytes in the clot of the blood column undergo necrosis, affecting its properties so the blood column is augmented by the use of different types of scaffolds. Platelet-rich fibrin is classified into four types (Standard PRF, Injectable PRF, Advanced PRF and Concentrated Growth Factor CGF) according to speed and time of centrifuge with the overall aim to increase the number of platelets and leucocytes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healing Potentiality After Regeneration Using Standard PRF and Advanced PRF in Mature Necrotic Single Teeth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

double blinded

Allocation

Randomized

Enrollment

57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blood Clot

Arm Type

Other

Arm Description

It is induced through apical foramen by penetrating the periapical area by stainless steel file size 30 to fill the root canal system by growth factors also to be considered as scaffold

Arm Title

Standard PRF

Arm Type

Active Comparator

Arm Description

Arm Title

Advanced PRF

Arm Type

Experimental

Arm Description

A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes

Intervention Type

Procedure

Intervention Name(s)

Advanced Platelet Rich fibrin

Intervention Description

Preparing of A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes

Primary Outcome Measure Information:

Title

healing Rate

Description

standardized digital radiograph

Time Frame

follow up to 6 months

Secondary Outcome Measure Information:

Title

Postoperative pain: NRS

Description

using neumerical rationg scale NRS . from zero to 10 . zero = no pain 1 to 3 = mild 4-6 = moderate 7-10 = severe

Time Frame

up to one year

Title

sensitivty

Description

using sensitivity tests

Time Frame

6 months to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Medically free patients who accept to participate in the study. Age between 18-35 years old with no sex predilection. Patients with good oral hygiene. Patients with necrotic pulp in mandibular & maxillary single rooted permanent teeth with mature apex that Symptomatic or Asymptomatic , Doesn't respond positively with the electric pulp tester ,Associated with or without swelling /sinus tract, Has radiographic evidence of periapical radiolucency, Has a straight, non-curved root, Teeth with normal occlusal contact with the opposing teeth. Exclusion Criteria: Illiterate patient because they can't estimate the pain level on the pain scale (NRS). Patients with systemic diseases or on systemic corticosteroids therapy because they have impaired healing and higher incidence of pain. Pregnant women to avoid radiation exposure during the treatment which may be hazardous to the fetus and breasts from dental X-ray examinations shields. Patients that have allergy to ciprofloxacin or metronidazole to avoid any allergic reaction after placement of bi-antibiotic paste as intra-canal medication. Patients reporting bruxism or clenching because this induce more pressure on teeth and may initiate the post-operative pain in the treated tooth which is already have peri-apical inflammation Teeth that, Have vertical root fracture, coronal perforation, and calcification, Are indicated for retreatment because they have lower success rate , Have pocket depth greater than 5mm,Need periodontal therapy , Non restorable , Hopeless tooth, patients that have T.M.J disorder

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

12345

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omnia Darwish, phD

Phone

01006670928

omniadarwish7@gmail.com

First Name & Middle Initial & Last Name & Degree

said Abdelaziz, Professor

Phone

01001005678

saiedmaziz@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Healing Potentiality Of Blood Clot ,S-PRF and A-PRF In Treatment Of Necrotic Mature Single Rooted Teeth With Chronic Peri-Apical Periodontitis

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