Evaluation of the Survival of Inflamed Mature Single Rooted Teeth

Short Term Success of Inflamed Mature Single Rooted Teeth With Symptomatic Apical Periodontitis Following Single Visit Regenerative Treatment Protocols (Randomized Clinical Trial)

The majority of articles present in literature concerning the enrollment of tissue engineering in the field of root canal treatment is concerned with the treatment of affected teeth with immature apex, after proper systematic search online, only 4 articles where found that are dealing with the treatment of teeth with mature apex. These 4 studies are case reports. None of these studies has been a randomized clinical trial, the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Since that the triad of regenerative endodontics are the key of success of any attempt to regenerate pulp, 2 different maneuvers shall be done in this study.

Study Overview

• Status: Unknown
• Conditions: Regeneration
• Intervention / Treatment: Procedure: Conventional; Procedure: PRF

Detailed Description

Preservation of the natural dentition had always been a primary objective in endodontic practice. When the pulp is diseased or requires removal for restorative reasons, it is replaced with an artificial filling material during conventional root canal treatment. Root canal treatment has lots of drawbacks, starting with different iatrogenic errors during endodontic procedures, weakening of remaining tooth structure which might affect the tooth survival. Also Root canal treated teeth require the placement of a post and core, which itself is doubtful whether it increases fracture resistance of the tooth or it weakens it. The most important drawback is that the survival of affected pulp is hindered by the conventional root canal treatment. Thus a new treatment approach was introduced utilizing the body ability to regenerate, called Pulp Regeneration. Regeneration was first introduced in the dental field as a solution for immature apex treatment, due to difficulties encountered during its conventional root canal treatment. Here the Pulp regeneration shall be used on vital mature teeth to increase the survival rate of the affected teeth.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Mostafa Omar Fahim, MSc; Phone Number: +201112367773; Email: mustafa.omar@dentistry.cu.edu.eg
    • Contact: Alaa AbdelSalam El-Baz, Professor; Phone Number: +201000826286; Email: alaa.elbaz@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
• Non-pregnant females
• Single canalled teeth.
• Patients having vital, mature, single rooted teeth, clinical evidence of pulpitis and apical periodontitis.
• 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.
• Non Vital teeth
• Immature teeth
• Traumatized teeth
• Radiographic evidence of external or internal root resorption.
• Single Rooted teeth with multiple canals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional; Conventional blood clot technique	Procedure: Conventional; Conventional Blood Clot Technique
Experimental: PRF; Platelet Rich Fibrin Technique	Procedure: PRF; Platelet Rich Fibrin Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of tooth Sensitivity	Electric Pulp Tester	1, 3, 6, 9, 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Clinical examination of tooth integrity	1, 3, 6, 9, 12 Months
Clinical Success	Clinical examination the signs & symptoms is present or absent	1, 3, 6, 9, 12 Months
Pericapical Status	CBCT assessment in Hounsfield unit	6, 9, 12 Months
Periapical Status	Digital Periapical Radiograph in pixels	1, 3, 6, 9, 12 Months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Araujo PRS, Silva LB, Neto APDS, Almeida de Arruda JA, Alvares PR, Sobral APV, Junior SA, Leao JC, Braz da Silva R, Sampaio GC. Pulp Revascularization: A Literature Review. Open Dent J. 2017 Jan 31;10:48-56. doi: 10.2174/1874210601711010048. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 3, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ENDO28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data will be made available
• IPD Sharing Time Frame: It will be available after finishing the study
• IPD Sharing Access Criteria: It will be uploaded on a folder on google drive to be accessed through this link URL: https://drive.google.com/open? id=1rZXDbSgsneWDO4xGz8KGkklEHHw2YYIX
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No