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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03725514
Enrollment
40
Registered
2018-10-31
Start date
2018-12-01
Completion date
2021-12-30
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regeneration

Brief 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.

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.

Interventions

PROCEDUREConventional

Conventional Blood Clot Technique

PROCEDUREPRF

Platelet Rich Fibrin Technique

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Sealed Opaque Envelopes

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of tooth Sensitivity1, 3, 6, 9, 12 MonthsElectric Pulp Tester

Secondary

MeasureTime frameDescription
Survival1, 3, 6, 9, 12 MonthsClinical examination of tooth integrity
Clinical Success1, 3, 6, 9, 12 MonthsClinical examination the signs & symptoms is present or absent
Pericapical Status6, 9, 12 MonthsCBCT assessment in Hounsfield unit
Periapical Status1, 3, 6, 9, 12 MonthsDigital Periapical Radiograph in pixels

Countries

Egypt

Contacts

Primary ContactMostafa O Fahim, MSc of Endodontics
Mostafa.o.fahim@gmail.com+201112367773
Backup ContactAlaa Baz, Ass. Prof Endodontics
alaa.elbaz@dentistry.cu.edu.eg01000826286

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026