Efficacy of Regenerative Endodontic Treatment With PRF as a Secondary Treatment of Mature Necrotic Incisors in Adolescents (PRF)
Primary Purpose
Dental Pulp Necroses
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
no intervention
Platelet rich fibrin
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Necroses focused on measuring platelet rich fibrin
Eligibility Criteria
Inclusion Criteria:
- Healthy patients below age of 18 years.
- Need endodontic retreatment of previously obturated closed apexes single-rooted incisors with gutta-percha.
- No previous attempts for endodontic retreatment.
- Presence of clinical signs and symptoms of chronic apical periodontitis
Exclusion Criteria:
- Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems were precluded.
- Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns
Sites / Locations
- Nahda UniversityRecruiting
- NahdaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Blood Clot BC (Control arm)
Platelets Rich Fibrin PRF (Intervention)
Arm Description
Regenerative endodontic treatment with induced Blood Clot in root canal space as a secondary treatment for failed root canal treated incisors
Regenerative endodontic treatment with Platelet- rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors
Outcomes
Primary Outcome Measures
Clinical success
Clinical assessment will be performed at the baseline (T0) and after 12 months (T1). Upon examination, clinical failure will be encountered if one of the following features will present: (i) pain on biting or percussion, (ii) swelling or sinus tract, or (iii) abnormal tooth mobility.
Radiographic success
For a standardized appraisal of the changes in the size of periapical radiolucency, long cone "paralleling technique" with a receptor holder was used after mounting a size II periapical film (Kodak International) to a silicone bite stent.
Secondary Outcome Measures
Pulp sensibility test
In the control and intervention groups, the pulp sensations will be tested with an electric pulp tester (EPT) (Pulp Tester DY 310, Denjoy Dental Co.) at T1 and T2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05517187
Brief Title
Efficacy of Regenerative Endodontic Treatment With PRF as a Secondary Treatment of Mature Necrotic Incisors in Adolescents
Acronym
PRF
Official Title
Clinical Success of Regenerative Endodontic Treatment With Platelets Rich Fibrin PRF as a Secondary Treatment of Mature Necrotic Incisors With Periapical Radiolucency in Adolescents: A Preliminary Parallel Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nahda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evalaution of clinical success of secondary treatment for total 40 permanent incisors with failed root canal treatment with apical radiolucency.
Twenty of of these permanent incisors will be treated with regenerative endodontic treatment(RET) with platelets rich fibrin PRF as intervention group vs. 20 incisors control group secondary treated with (RET) with induced blood clot (BC).
Detailed Description
A preliminary randomized parallel controlled trial will be conducted. Forty teeth of 36 patients were randomly assigned into two groups: group "PRF", treated with RET with PRF platelets rich fibrin (intervention), and group "BC", treated with RET with induced blood clot(control). Upon clinical examination, the presence of pain on biting or percussion, swelling or sinus tract, or abnormal tooth mobility will be considered a failure. To monitor the changes in periapical radiolucency, a periapical index (PAI) will be used. The primary outcome of the current study will be to assess the effectiveness of RET using PRF platelets rich fibrin of mature permanent incisors with periapical radiolucency compared to RET using induced BC formation in the root canal space.
Eligibility criteria:
Healthy adolescents below the age of 18 years who need endodontic retreatment of previously obturated mature single-rooted incisors with gutta-percha will be recruited.
Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems will be precluded. Only teeth diagnosed with asymptomatic apical periodontitis or chronic apical abscess (i.e. little discomfort with intermittent episodes of pus discharge through the sinus tract) were included. To confirm the clinical status, only teeth with a periapical index (PAI) score ≥3 based on Ørstavik et al classification were considered. Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns or need post placement, or periodontal problems were excluded. A tooth must not be a candidate for endodontic surgery according to Glickman et al. indications and the updates of the European Society of Endodontology (e.g. obtaining biopsy, removal of intracanal broken files, persistent periapical lesions standing for a long period, radicular perforation, root fracture, or obstructed root canals, or the inability of complete removal of old gutta-percha or extruded material beyond the apex with persistent apical lesion for long duration).
Interventions:
According to the latest RET operating guidelines issued by the American Academy of Endodontics (AAE) and the European Society of Endodontics (ESE), the standardised operating procedure of RET requires two treatment visits. During the first appointment, infection is controlled and inflammation is relieved with complete removal of failed obturation material. Pulp regeneration and revascularization is accomplished during the second appointment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Necroses
Keywords
platelet rich fibrin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood Clot BC (Control arm)
Arm Type
Placebo Comparator
Arm Description
Regenerative endodontic treatment with induced Blood Clot in root canal space as a secondary treatment for failed root canal treated incisors
Arm Title
Platelets Rich Fibrin PRF (Intervention)
Arm Type
Experimental
Arm Description
Regenerative endodontic treatment with Platelet- rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
Regenerative endodontic treatment induced with blood clot in root canal space as a secondary treatment for failed root canal treated incisors
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin
Intervention Description
Regenerative endodontic treatment with platelet rich fibrin in root canal space as a secondary treatment for failed root canal treated incisors
Primary Outcome Measure Information:
Title
Clinical success
Description
Clinical assessment will be performed at the baseline (T0) and after 12 months (T1). Upon examination, clinical failure will be encountered if one of the following features will present: (i) pain on biting or percussion, (ii) swelling or sinus tract, or (iii) abnormal tooth mobility.
Time Frame
12 months
Title
Radiographic success
Description
For a standardized appraisal of the changes in the size of periapical radiolucency, long cone "paralleling technique" with a receptor holder was used after mounting a size II periapical film (Kodak International) to a silicone bite stent.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pulp sensibility test
Description
In the control and intervention groups, the pulp sensations will be tested with an electric pulp tester (EPT) (Pulp Tester DY 310, Denjoy Dental Co.) at T1 and T2.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy patients below age of 18 years.
Need endodontic retreatment of previously obturated closed apexes single-rooted incisors with gutta-percha.
No previous attempts for endodontic retreatment.
Presence of clinical signs and symptoms of chronic apical periodontitis
Exclusion Criteria:
Patients with a positive history of allergic reactions, systemic diseases, and severe emotional or behavioral problems were precluded.
Teeth with previous attempts for endodontic retreatment including pulpotomy or pulpectomy, non-restorable crowns
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yassmine Farouk Mekawi, PhD
Phone
01006526611
Email
yassmin.mohamed@nub.edu.eg
Facility Information:
Facility Name
Nahda University
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmin
Facility Name
Nahda
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmin
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Regenerative Endodontic Treatment With PRF as a Secondary Treatment of Mature Necrotic Incisors in Adolescents
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