Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques

NCT ID: NCT02915419

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-31

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.

Conditions

Carious Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

prp revascularization

Group Type: ACTIVE_COMPARATOR

PRP

Intervention Type: BIOLOGICAL

platelet rich plasma

PRF

Intervention Type: BIOLOGICAL

PLATELET RICH FIBRIN

group B

treatment of affected teeth using platelet rich fibrin by applying prf in steril root canal

Group Type: EXPERIMENTAL

PRP

Intervention Type: BIOLOGICAL

platelet rich plasma

PRF

Intervention Type: BIOLOGICAL

PLATELET RICH FIBRIN

Interventions

PRP

platelet rich plasma

Intervention Type: BIOLOGICAL

PRF

PLATELET RICH FIBRIN

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Wagih Tarek Ali

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

wagih ali, ass lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

wagih ali, ass.lecturer

Role: CONTACT

wagihtarek.a@gmail.com

00201065550505

References

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.

Reference Type: BACKGROUND

PMID: 26071100 (View on PubMed)

Other Identifiers

CEBD-CU-2016-09-203

Identifier Type: -

Identifier Source: org_study_id