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Dental Pulp NecrosisRCTNCT03652129

Digitized Assessment for the Survival of Mature Anterior Teeth With Periapical Lesion After One Step Regenerative Approach Using Different Asepsis Maneuvers

A study testing Disinfection in people with Dental Pulp Necrosis and Dental Pulp Disease, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trial is designed to allow revascularization and tissue engineering in necrotic teeth with peripical lesion in a single visit approach. different disinfection protocols is used to ensure that adequate disinfection of root canals is achieved to allow stem cells to differentiate and proliferate generating pulp like… Read more about this study

Who is it for?
Ages 15 to 50 yearsHealthy volunteers can take part
What is being tested?
Disinfection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
22 Aug 2018to 1 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
  • Non-pregnant females
  • Single canalled anterior teeth.
  • Patients having non-vital, mature, anterior teeth, radiographic evidence of periapical lesion.
  • Positive patient/Guardian compliance for participation in the study.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry

    Cairo

Other trials in Egypt

About this study

Trial is designed to allow revascularization and tissue engineering in necrotic teeth with peripical lesion in a single visit approach. different disinfection protocols is used to ensure that adequate disinfection of root canals is achieved to allow stem cells to differentiate and proliferate generating pulp like tissue and turning back tooth to live with periapical healing of resorbed bone.

Read the 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 controversies, starting with weakening of remaining tooth structure, affecting the tooth survival. Also Root canal treated teeth are considered to be weaker than vital tooth, requiring the placement of a post and core, which itself is doubtful whether it increases fracture resistance of the tooth or it weakens it.1 The most important controversy is that the survival of affected pulp is hindered by the conventional root canal treatment2. 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, as it is very difficult to treat them using the conventional root canal treatment3 American Dental Association adopted the tissue engineering concept and pulp regeneration in 20114. 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. Depending on the success of pulp regeneration in treating immature teeth, ambitious dentists started to look forward on treating mature teeth as a substitution to the conventional root canal treatment. 5

A shift to tissue engineering took place. 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 .6 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.7

These doubts 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 documented8. 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 9.

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 PRF10. One protocol of the regenerative approach is the use of Antibiotic paste as intra canal medicament in a 2 step procedures, due to the world wide trend of limitation of the use of antibiotics systemically and locally the assessment of the outcome of single visit regenerative approach is mandatory, and because the main limitation for such intervention is adequate disinfection of root canal assessment of different asepsis maneuvers is also of great importance since literature and evidence based information lack any studies assessing such techniques.

The clinician at the end of this study must determine which disinfection protocol allows for more survival of tooth, revitalization of the affected mature tooth and faster healing of periapical lesion following one step regenerative approach. Healing will be measured using digital radiography and cone beam computed topography11. Repair of the tooth neural innervation will be tested by electric pulp tester12.

Being tested
Disinfection
Medical subject headings
Dental Pulp Necrosis, Dental Pulp Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DisinfectionProcedure or surgery

    Disinfection maneuver using LASER and nano irrigant

Study groups in NCT03652129
Study groupRoleWhat they receive
Laser GroupExperimentalDisinfection using biostimulating LASER
Receives: Procedure: Disinfection
Nano irrigant GroupExperimentalDisinfection using Nano irrigant
Receives: Procedure: Disinfection
Conventional irrigation protocol groupActive comparatordisinfection using normal irrigation protocols
Receives: Procedure: Disinfection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Periapical Healing

    Bone healing

    Measured: 1 year

Secondary outcomes (2)
  1. Survival of tooth

    tooth survival after procedure

    Measured: 1 year

  2. Sensitivity

    assess sensitivity using pulp tester

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study start22 Aug 2018
  3. Primary completion1 Dec 2019
  4. Study completion1 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03652129
Sponsor's protocol ID
Regerative Endodontics
Acronym
RCT
Status last verified
Feb 2020
First submitted
28 Aug 2018
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Disinfection in people with Dental Pulp Necrosis and Dental Pulp Disease, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periapical Healing (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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