Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques
Primary Purpose
Carious Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRP
PRF
Sponsored by
About this trial
This is an interventional treatment trial for Carious Teeth
Eligibility Criteria
Inclusion Criteria:
- Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
Non-pregnant females Single canalled second premolar
- Patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion.
- Positive patient/Guardian compliance for participation in the study.
Exclusion Criteria:
- Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
Non-restorable coronal portion of teeth involved in the trial. Vital teeth Immature teeth Traumatized teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
group A
group B
Arm Description
prp revascularization
treatment of affected teeth using platelet rich fibrin by applying prf in steril root canal
Outcomes
Primary Outcome Measures
Survival
how long will the tooth survive after treatment, testing the durability of tooth
Secondary Outcome Measures
healing
measuring the density of lesion using the cone beam CT
vitality
after how many days will the tooth respond normaly to stimulus
Full Information
NCT ID
NCT02915419
First Posted
September 20, 2016
Last Updated
September 23, 2016
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT02915419
Brief Title
Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques
Official Title
Evaluation of Survival of Mature Second Premolar With Periapical Lesion Following Different Regenerative Treatment Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare the ability of different regenerative protocols in the treatment of mature necrotic
Detailed Description
American Dental Association adopted the tissue engineering concept and pulp regeneration in 2009. Regeneration was focused on the treatment of immature necrotic teeth so as to allow root completion, improving both the functionality and durability of the affected tooth. Utilizing a blood clot in the affected tooth with immature roots was very beneficial, as it acts as a scaffold for the migration of stem cells and morphogens to allow regeneration .
Based on the success of pulp regeneration in treating immature teeth, ambitious dentists started to look forward on regenerating the pulp of mature teeth as a substitution to the conventional root canal treatment. On the other hand, lots of clinicians were very doubtful about treating mature teeth with the same protocol, as the small apical foramen might not provide a good portal for the entry of stem cells and growth factors, which in turn is very important for the success of pulp regeneration.Doubts in treating mature apex encouraged researchers to look for an alternative to the stem cells other than the apical papilla, from this concept the idea for using an alternative source of stem cells and growth factors as platelet rich plasma (PRP) emerged. The use of platelet rich plasma (PRP) as a potentially ideal scaffold for regenerative endodontic therapy has been reported in the treatment of immature teeth. However, the use of bovine thrombin for the activation of PRP has been an issue of controversy, as it requires non autologous anticoagulant known to hinder the process of pulp regeneration.
This led to the development of the second generation, platelet concentrate known as Choukroun's platelet rich fibrin (PRF) which is totally autologous in nature. Platelet rich fibrin (PRF) was very promising, but it is debatable whether to use PRP or PRF.The objective of this study is to evaluate novel regenerative techniques, utilizing platelet rich plasma and platelet rich fibrin in treatment of second premolar teeth with necrotic pulp, mature apex, and periapical lesion. This is a trial to prolong the survival of the affected tooth, and to aid in complete healing of periapical lesion, and to regain pulp vitality and sensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carious Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
prp revascularization
Arm Title
group B
Arm Type
Experimental
Arm Description
treatment of affected teeth using platelet rich fibrin by applying prf in steril root canal
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
platelet rich plasma
Intervention Type
Biological
Intervention Name(s)
PRF
Intervention Description
PLATELET RICH FIBRIN
Primary Outcome Measure Information:
Title
Survival
Description
how long will the tooth survive after treatment, testing the durability of tooth
Time Frame
1 year
Secondary Outcome Measure Information:
Title
healing
Description
measuring the density of lesion using the cone beam CT
Time Frame
1 year
Title
vitality
Description
after how many days will the tooth respond normaly to stimulus
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
sensitivity
Description
after how many days will the tooth respond positively to electric pulp tester
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
Non-pregnant females Single canalled second premolar
Patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion.
Positive patient/Guardian compliance for participation in the study.
Exclusion Criteria:
Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
Non-restorable coronal portion of teeth involved in the trial. Vital teeth Immature teeth Traumatized teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wagih ali, ass.lecturer
Phone
00201065550505
Email
wagihtarek.a@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wagih ali, ass lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26071100
Citation
Wang Y, Zhu X, Zhang C. Pulp Revascularization on Permanent Teeth with Open Apices in a Middle-aged Patient. J Endod. 2015 Sep;41(9):1571-5. doi: 10.1016/j.joen.2015.04.022. Epub 2015 Jun 10.
Results Reference
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Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques
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