Apical PeriodontitisNCT04158232
Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
A study testing Method in people with Apical Periodontitis, run by Minia University.
Trial summary
Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Read more about this study
- Who is it for?
- Ages 11 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2019to 2 Nov 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 11 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with mature teeth.
- Patients with periapical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow up period.
Who cannot join
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1 year follow up.
- Patients with fistula.
Show all 10Show fewer
- Patients with old age.
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Unrestorable teeth.
About this study
Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.
- Conditions
- Apical Periodontitis
- Being tested
- Method
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethodOther
treatment of mature teeth with apical periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Blood clotting protocol for pulp regeneration | Active comparator | pulp regeneration for mature teeth using blood clotting protocol Receives: Other: Method |
| platelet rich fibrin for pulp regeneration | Experimental | pulp regeneration for mature teeth using platelet rich fibrin (PRF) Receives: Other: Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
pulp vitality testing using electric pulp tester which detect response of pulp to electric current
Measured: 9 months
radiographic success
healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start2 Nov 2019 (estimated)
- Primary completion2 Sep 2020 (estimated)
- Study completion2 Nov 2020 (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 Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Minia 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, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158232
- Sponsor's protocol ID
- 306
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.
PubMed 35030270
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
- ClinicalTrials.gov ID
- NCT04158232
- Acronym / sponsor ID
- 306
- Conditions
- Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 2 Nov 2019 (estimated)
- Primary completion
- 2 Sep 2020 (estimated)
- Study completion
- 2 Nov 2020 (estimated)
- First posted
- 8 Nov 2019 (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.
Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood clotting protocol for pulp regeneration | Active comparator | Other: Methodpulp regeneration for mature teeth using blood clotting protocol |
| platelet rich fibrin for pulp regeneration | Experimental | Other: Methodpulp regeneration for mature teeth using platelet rich fibrin (PRF) |
Who may qualify
- Ages
- 11 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with mature teeth.
- Patients with periapical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow up period.
Key exclusion criteria (10 listed)
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1 year follow up.
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 |
|---|---|---|
| Methodtreatment of mature teeth with apical periodontitis | Other | Blood clotting protocol for pulp regeneration, platelet rich fibrin for pulp regeneration |
Primary outcome
clinical success
Time frame: 9 months
pulp vitality testing using electric pulp tester which detect response of pulp to electric current
radiographic success
Time frame: 9 months
healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Derived from this study: PubMed 35030270Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Method in people with Apical Periodontitis, run by Minia University.
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 10 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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 success (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT04158232, 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 Nov 2019.