RegenerationNCT03725514
Evaluation of the Survival of Inflamed Mature Single Rooted Teeth
A study testing Conventional and PRF in people with Regeneration, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Regeneration
- What is being tested?
- Conventional and PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 30 Dec 2021
- 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 16 to 25 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 teeth.
- Patients having vital, mature, single rooted teeth, clinical evidence of pulpitis and apical periodontitis.
- 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.
- Non Vital teeth
- Immature teeth
- Traumatized teeth
- Radiographic evidence of external or internal root resorption.
- Single Rooted teeth with multiple canals.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Mostafa Omar Fahim, MSc, +201112367773, mustafa.omar@dentistry.cu.edu.eg
Alaa AbdelSalam El-Baz, Professor, +201000826286, alaa.elbaz@yahoo.com
About this study
Official title: Short Term Success of Inflamed Mature Single Rooted Teeth With Symptomatic Apical Periodontitis Following Single Visit Regenerative Treatment Protocols (Randomized Clinical Trial)
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.
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 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
- Regeneration
- Being tested
- Conventional, PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalProcedure or surgery
Conventional Blood Clot Technique
PRFProcedure or surgery
Platelet Rich Fibrin Technique
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | Conventional blood clot technique Receives: Procedure: Conventional |
| PRF | Experimental | Platelet Rich Fibrin Technique Receives: Procedure: PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tooth Sensitivity
Electric Pulp Tester
Measured: 1, 3, 6, 9, 12 Months
Secondary outcomes (4)
Survival
Clinical examination of tooth integrity
Measured: 1, 3, 6, 9, 12 Months
Clinical Success
Clinical examination the signs \& symptoms is present or absent
Measured: 1, 3, 6, 9, 12 Months
Pericapical Status
CBCT assessment in Hounsfield unit
Measured: 6, 9, 12 Months
Periapical Status
Digital Periapical Radiograph in pixels
Measured: 1, 3, 6, 9, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Dec 2018
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RegenerationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Omar Fahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725514
- Sponsor's protocol ID
- ENDO28
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be made available
Publications
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.
PubMed 28567136
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Success of Inflamed Mature Single Rooted Teeth With Symptomatic Apical Periodontitis Following Single Visit Regenerative Treatment Protocols (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03725514
- Acronym / sponsor ID
- ENDO28
- Conditions
- Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 31 Oct 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | Active comparator | Procedure: ConventionalConventional blood clot technique |
| PRF | Experimental | Procedure: PRFPlatelet Rich Fibrin Technique |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| ConventionalConventional Blood Clot Technique | Procedure or surgery | conventional |
| PRFPlatelet Rich Fibrin Technique | Procedure or surgery | PRF |
Primary outcome
Change of tooth Sensitivity
Time frame: 1, 3, 6, 9, 12 Months
Electric Pulp Tester
4 secondary outcomes
Survival
Time frame: 1, 3, 6, 9, 12 Months
Clinical Success
Time frame: 1, 3, 6, 9, 12 Months
Pericapical Status
Time frame: 6, 9, 12 Months
Periapical Status
Time frame: 1, 3, 6, 9, 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 28567136Araujo 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.
- Individual participant dataSharing planned: Yes. Participant data will be made available
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional and PRF in people with Regeneration, 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: status not confirmed, as of the sponsor's last update on 8 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa O Fahim, MSc of Endodontics (+201112367773, Mostafa.o.fahim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of tooth Sensitivity (time frame: 1, 3, 6, 9, 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03725514, which also lists 1 linked publication.
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 8 Oct 2020.