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.
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
- Conditions the study is for
- Regenerative Endodontic Procedures, Necrotic Pulp
- 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
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
- 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).
- 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):
- Preparation of h-TDM: Mentioned before.
- 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.
- Conditions
- Regenerative Endodontic Procedures, Necrotic Pulp
- 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 group | Role | What they receive |
|---|---|---|
| Treated Dentine Matrix (TDM) | Experimental | Participants treated with TDM paste Receives: Other: Regenerative endodontic procedues |
| Platelet Rich Fibrin (PRF) | Experimental | Participants 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.
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)
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.
- First posted20 Mar 2023
- Study start15 Jul 2021
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative Endodontic ProceduresStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed A Asal, MDS, Principal investigator, Mansoura UniversityIbrahim H Elkalla, PhD, Study chair, Mansoura UniversityYousry M Elhawary, PhD, Study director, Mansoura UniversityAshraf Y Alhsoainy, PhD, Study director, Mansoura University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Human Treated Dentine Matrix and Platelet Rich Fibrin in Induction of Root Formation of Non-Vital Immature Permanent Teeth
- ClinicalTrials.gov ID
- NCT05775081
- Acronym / sponsor ID
- A07060721
- Conditions
- Regenerative Endodontic Procedures, Necrotic Pulp
- Keywords
- Platelet rich fibrin, Treated dentine matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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).
- 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):
- Preparation of h-TDM: Mentioned before.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Dentine Matrix (TDM) | Experimental | Other: Regenerative endodontic proceduesParticipants treated with TDM paste |
| Platelet Rich Fibrin (PRF) | Experimental | Other: Regenerative endodontic proceduesParticipants treated with PRF |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients aged from 6-11 years presenting with a non-vital permanent immature tooth.
Key exclusion criteria (4 listed)
- History of uncontrolled diabetes
- Immunosuppression
- Chronic systemic disease if a treatment is required
- Periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenerative endodontic proceduesTreating non-vital immature permanent teeth with either treated dentine matrix paste or platelet rich fibrin | Other | Platelet Rich Fibrin (PRF), Treated Dentine Matrix (TDM) |
Primary outcome
Clinical evaluation
Time frame: 15 months
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.
1 secondary outcome
Radiographic evaluation
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Regenerative Endodontic Procedures
Not yet recruitingObservational study
The Effect of Using Different Scaffolds in Retreated Teeth on The Clinical and Radiological Success of Regenerative Endodontic Treatment
Endodontics, Regenerative Endodontic Procedures
Active, not recruiting
Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
Immature Permanent Teeth With Open Apex, Pulp Necrosis
Enrolling by invitation
Maximum Occlusal Bite Force of Necrotic Permanent Teeth Treated by Regenerative Technique: Randomized Clinical Trial
Necrotic Pulp, Regenerative Endodontic Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Asal, MDS principal investigator
Mansoura University
Ibrahim H Elkalla, PhD study chair
Mansoura University
Yousry M Elhawary, PhD study director
Mansoura University
1 site in 1 country: see every site and its status.
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.