Evaluation of the Survival of Inflamed Mature Single Rooted Teeth

NCT ID: NCT03725514

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Sealed Opaque Envelopes

Study Groups

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conventional

Conventional blood clot technique

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type PROCEDURE

Conventional Blood Clot Technique

PRF

Platelet Rich Fibrin Technique

Group Type EXPERIMENTAL

PRF

Intervention Type PROCEDURE

Platelet Rich Fibrin Technique

Interventions

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Conventional

Conventional Blood Clot Technique

Intervention Type PROCEDURE

PRF

Platelet Rich Fibrin Technique

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Omar Fahim

Assistant Lecturer of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mostafa O Fahim, MSc of Endodontics

Role: CONTACT

+201112367773

Alaa Baz, Ass. Prof Endodontics

Role: CONTACT

01000826286

Facility Contacts

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Mostafa Omar Fahim, MSc

Role: primary

+201112367773

Alaa AbdelSalam El-Baz, Professor

Role: backup

+201000826286

References

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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.

Reference Type BACKGROUND
PMID: 28567136 (View on PubMed)

Other Identifiers

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ENDO28

Identifier Type: -

Identifier Source: org_study_id

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