Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques

Carious Teeth Clinical Trial

Official title:

Evaluation of Survival of Mature Second Premolar With Periapical Lesion Following Different Regenerative Treatment Protocols

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02915419
• Other study ID #: CEBD-CU-2016-09-203
• Status: Not yet recruiting
• Phase: N/A
• First received: September 20, 2016
• Last updated: September 23, 2016
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2016
• Source: Cairo University
• Contact: wagih ali, ass.lecturer
• Phone: 00201065550505
• Email: wagihtarek.a[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the ability of different regenerative protocols in the treatment of mature necrotic

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carious Teeth
• Dental Caries

Intervention

Biological:
• PRP
platelet rich plasma
• PRF
PLATELET RICH FIBRIN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sensitivity	after how many days will the tooth respond positively to electric pulp tester	1 year	Yes
Primary	Survival	how long will the tooth survive after treatment, testing the durability of tooth	1 year	Yes
Secondary	healing	measuring the density of lesion using the cone beam CT	1 year	Yes
Secondary	vitality	after how many days will the tooth respond normaly to stimulus	1 year	Yes