Evaluation of the Survival of Inflamed Mature Single Rooted Teeth

Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03725514
• Other study ID #: ENDO28
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: Mostafa O Fahim, MSc of Endodontics
• Phone: +201112367773
• Email: Mostafa.o.fahim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 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 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.

Related Conditions & MeSH terms

• Regeneration

Intervention

Procedure:
• Conventional
Conventional Blood Clot Technique
• PRF
Platelet Rich Fibrin Technique

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Araújo PRS, Silva LB, Neto APDS, Almeida de Arruda JA, Álvares PR, Sobral APV, Júnior SA, Leão 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of tooth Sensitivity	Electric Pulp Tester	1, 3, 6, 9, 12 Months
Secondary	Survival	Clinical examination of tooth integrity	1, 3, 6, 9, 12 Months
Secondary	Clinical Success	Clinical examination the signs & symptoms is present or absent	1, 3, 6, 9, 12 Months
Secondary	Pericapical Status	CBCT assessment in Hounsfield unit	6, 9, 12 Months
Secondary	Periapical Status	Digital Periapical Radiograph in pixels	1, 3, 6, 9, 12 Months