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Regenerative Endodontic ProceduresNCT05775081

Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth

A study testing Regenerative endodontic procedues in people with Regenerative Endodontic Procedures and Necrotic Pulp, run by Mansoura 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

This study will be conducted to clinically evaluate the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth. Read more about this study

Who is it for?
Ages 6 to 11 yearsHealthy volunteers can take part
What is being tested?
Regenerative endodontic procedues
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
15 Jul 2021to 15 Dec 2023
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 6 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patients aged from 6-11 years presenting with a non-vital permanent immature tooth.

Who cannot join

  • History of uncontrolled diabetes
  • Immunosuppression
  • Chronic systemic disease if a treatment is required
  • Periodontal disease

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry, Mansoura University

    Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

Official title: Efficacy of Human Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth

This study will be conducted to clinically evaluate the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.

Read the detailed description
  1. Patient grouping:

Patients will be randomly allocated into 2 groups using sealed envelope method of randomization

Group (A):

Teeth to be treated by h-TDM paste (n=10).

Group (B):

Teeth to be treated by platelet rich fibrin (PRF) regeneration (n=10).

  1. Procedures:

Diagnosis of pulp necrosis, clinical and radiographic examination. 11 For each patient, the protocol of treatment is composed of 7 sessions. The follow-up takes place over a 15 months' period. Day 0 is considered as the day of the first treatment session.

I- Day 0:

  • Pre-operative Cone Beam Computed Tomography (CBCT) is taken at this visit.
  • Calcium hydroxide canal conditioning for 2 weeks regardless of the treatment group. This is done in the following sequence:
  • Administration of local anesthesia, then rubber dam isolation.
  • Preparing an access cavity and establishing the working length by taking a radiograph with a file inserted into the root canal within 2 mm of the radiographic apex.
  • The canal is cleaned by irrigation with 1.25% sodium hypochlorite and the use of manual files. The cleaning and shaping are realized with files with a very light parietal action to avoid the canal widening and the weakening of the root walls. Above all, it consists in removing the pulp remnants.
  • Then, the canal is dried with paper point and can be filled with calcium hydroxide. Calcium hydroxide paste is prepared by mixing the calcium hydroxide powder and Barium Sulfate as a radio-opacifier mixed with sterile distilled water. A plug of calcium hydroxide is placed in the canal and condensed to the apical end of the root with a plugger. Other layers of calcium hydroxide are placed till complete canal filling.
  • The intracanal dressing quality is checked with a radiograph. The access cavity is temporarily sealed with a resin modified glass ionomer cement. This calcium hydroxide canal conditioning is performed for all patients to allow the complete disinfection.

II- Day 0+15:

This session starts with administration of local anesthesia, placement of a rubber dam and the removal of all the calcium hydroxide by copious saline irrigation. Then, treatment according to the assigned group:

Group A (h-TDM paste):

  1. Preparation of h-TDM: Mentioned before.
  2. Preparation of h-TDM paste:

Mentioned before. 3- Operative procedures:

  • The h-TDM paste will be placed into the canal by sterile amalgam carrier and condensed to the apical end of the root with a plugger to create a 4 mm apical plug. Radiograph will be taken to verify proper placement of the mixture. Then, 1mm of MTA will be placed over this paste.
  • Then, the access cavity will be filled with resin modified glass ionomer.

Group B (PRF regeneration):

13

  • Ten ml of venous blood will be withdrawn from the child's forearm to a sterile test tube without anticoagulant and will be centrifuged in 3000 rpm for 10 minutes to prepare PRF, which appears as a membrane between the free plasma in the top and RBCs in the bottom of the tube.
  • Platelet rich fibrin will be withdrawn from the test tube using sterile tweezer and put into sterile gauze and cut into small pieces using sterile scissor.
  • Root canal will be copiously irrigated by sterile saline and dried with sterile paper points. Platelet rich fibrin small pieces will be condensed into the root canal till the apex using sterile plugger. Then, 2mm of MTA will be placed over the PRF till CEJ. Then, access cavity will be sealed by glass ionomer.

III- 3 months:

Clinical and radiographic control for all patients.

IV- 6 months:

Clinical and radiographic control for all patients.

V- 9 months:

Clinical and radiographic control for all patients.

VI- 12 months:

  • Clinical and radiographic control for all patients.

VII- 15 months:

  • Clinical and radiographic control for all patients.
  • CBCT is taken at this visit. The x-rays of each patient are taken with the aid of film holder to be standardized and reproducible, so that they can be compared.
Being tested
Regenerative endodontic procedues
Keywords
Platelet rich fibrin, Treated dentine matrix
Medical subject headings
Dental Pulp Necrosis

What participants receive

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

  • Regenerative endodontic proceduesOther

    Treating non-vital immature permanent teeth with either treated dentine matrix paste or platelet rich fibrin

Study groups in NCT05775081
Study groupRoleWhat they receive
Treated Dentine Matrix (TDM)ExperimentalParticipants treated with TDM paste
Receives: Other: Regenerative endodontic procedues
Platelet Rich Fibrin (PRF)ExperimentalParticipants treated with PRF
Receives: Other: Regenerative endodontic procedues

What is being measured

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

  1. Clinical evaluation

    Clinically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.

    Measured: 15 months

Secondary outcomes (1)
  1. Radiographic evaluation

    Radiographically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.

    Measured: 15 months

Timeline

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

  1. First posted20 Mar 2023
  2. Study start15 Jul 2021
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05775081
Sponsor's protocol ID
A07060721
Status last verified
Sep 2023
First submitted
7 Mar 2023
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Regenerative endodontic procedues in people with Regenerative Endodontic Procedures and Necrotic Pulp, run by Mansoura 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 1 inclusion and 4 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 13 Mar 2024. 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?

Clinical evaluation (time frame: 15 months). 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 13 Mar 2024.

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