Regenerative EndodonticsNCT05892536
Regenerative Endodontics in Mature Permanent Teeth
A study testing dental regenerative endodontics in people with Regenerative Endodontics, run by Salma fathy at 1 site in Egypt.
Trial summary
this study was designed to compare the clinical and radiographic success of REPs after using blood clot scaffold in non-vital mature permanent teeth with or without photobiomodultion therapy Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Regenerative Endodontics
- What is being tested?
- dental regenerative endodontics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to 30 Jan 2022
- 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients free from any systemic diseases or genetic disorders.
- Children aged 9-13 years old of both sexes.
- Traumatically or cariously exposed single rooted mature permanent teeth which may be asymptomatic or manifested with dull ache pain, or spontaneous unprovoked toothache.
- Non-vital single rooted mature permanent teeth that indicated for endodontic treatment
- Swelling close to involved tooth accompanied with or without fistula.
- Negative response to cold \& electrical pulp test.
- Informed Consent.
Who cannot join
- Unrestorable teeth, or that need post and core for the final restoration.
- Immature permanent teeth.
- Known allergy, sensitivity to ciprofloxacin, metronidazol.
- Uncooperativeness of child and/or parents or caregiver's behavior.
- Presence of calcific metamorphosis inside root canals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Photobiomodulation on Revascularization of Mature Non-vital Permanent Teeth Using Blood Clot as Scaffold
this study was designed to compare the clinical and radiographic success of REPs after using blood clot scaffold in non-vital mature permanent teeth with or without photobiomodultion therapy
- Conditions
- Regenerative Endodontics
- Being tested
- dental regenerative endodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental regenerative endodonticsProcedure or surgery
regenerative procedures performed in necrotic mature permanent teeth
| Study group | Role | What they receive |
|---|---|---|
| blood clot regeneration | Experimental | the regenerative procedures were performed by over-instrumentation the apices and irritating the apical tissues to induce bleeding into the root canal, then orifices plugged with MTA over blood clot and restored with GI. Receives: Procedure: dental regenerative endodontics |
| photo-biomodulation regeneration | Active comparator | photobiomodulation therapy was carried out using diode laser with wavelenght 810 nm and output power 300 mW on the apical root areas of buccal and lingual surfaces at 48 hours intervals for 2 weeks after completion of the regenerative procedures which were performed by over-instrumentation the apices and irritating the apical tissues to induce bleeding into the root canal, then orifices plugged with MTA over blood clot and restored with GI. Receives: Procedure: dental regenerative endodontics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp sensibility
clinical evaluation of pulp sensibility using electric pulp tester as a measurement tool
Measured: Every 3 months over a period of one year
Radiographic evaluation of periapical tissues
Radiographic evaluation using standardized digital radiograph that stored in computer for assessment of periapical tissues status using scoring system:
- Score 0 - No radiological changes seen compared to preoperative radiograph
- Score 1 - Slight decrease in radiolucency seen in periapical region
- Score 2 - Complete reduction or resolution of radiolucency seen in periapical region.
Measured: Every 3 months over a period of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start5 Jan 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative EndodonticsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salma fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salma fathy, Minia University
- Investigators
- salma khattab, master, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892536
- Sponsor's protocol ID
- 364
- Status last verified
- Apr 2023
- First submitted
- 18 Oct 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Photobiomodulation on Revascularization of Mature Non-vital Permanent Teeth Using Blood Clot as Scaffold
- ClinicalTrials.gov ID
- NCT05892536
- Acronym / sponsor ID
- 364
- Conditions
- Regenerative Endodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Salma fathyUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 7 Jun 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 was designed to compare the clinical and radiographic success of REPs after using blood clot scaffold in non-vital mature permanent teeth with or without photobiomodultion therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood clot regeneration | Experimental | Procedure: dental regenerative endodonticsthe regenerative procedures were performed by over-instrumentation the apices and irritating the apical tissues to induce bleeding into the root canal, then orifices plugged with MTA over blood clot and restored with GI. |
| photo-biomodulation regeneration | Active comparator | Procedure: dental regenerative endodonticsphotobiomodulation therapy was carried out using diode laser with wavelenght 810 nm and output power 300 mW on the apical root areas of buccal and lingual surfaces at 48 hours intervals for 2 weeks after completion of the regenerative procedures which were performed by over-instrumentation the apices and irritating the apical tissues to induce bleeding into the root canal, then orifices plugged with MTA over blood clot and restored with GI. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients free from any systemic diseases or genetic disorders.
- Children aged 9-13 years old of both sexes.
- Traumatically or cariously exposed single rooted mature permanent teeth which may be asymptomatic or manifested with dull ache pain, or spontaneous unprovoked toothache.
- Non-vital single rooted mature permanent teeth that indicated for endodontic treatment
- Swelling close to involved tooth accompanied with or without fistula.
Key exclusion criteria (5 listed)
- Unrestorable teeth, or that need post and core for the final restoration.
- Immature permanent teeth.
- Known allergy, sensitivity to ciprofloxacin, metronidazol.
- Uncooperativeness of child and/or parents or caregiver's behavior.
- Presence of calcific metamorphosis inside root canals.
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 |
|---|---|---|
| dental regenerative endodonticsregenerative procedures performed in necrotic mature permanent teeth | Procedure or surgery | blood clot regeneration, photo-biomodulation regeneration |
Primary outcome
Pulp sensibility
Time frame: Every 3 months over a period of one year
clinical evaluation of pulp sensibility using electric pulp tester as a measurement tool
Radiographic evaluation of periapical tissues
Time frame: Every 3 months over a period of one year
Radiographic evaluation using standardized digital radiograph that stored in computer for assessment of periapical tissues status using scoring system: 1. Score 0 - No radiological changes seen compared to preoperative radiograph 2. Score 1 - Slight decrease in radiolucency seen in periapical region 3. Score 2 - Complete reduction or resolution of radiolucency seen in periapical region.
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 7 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Regenerative Endodontics
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
Not yet recruiting
Regenerative Endodontics in Mature Necrotic Teeth
Necrotic Teeth With Chronic Apical Periodontitis
Recruiting
Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment
Apical Periodontitis, Periapical Diseases
Active, not recruiting
Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
Immature Permanent Teeth With Open Apex, Pulp Necrosis
Active, not recruiting
Comparison Between Emdogain and Amniotic Membrane as a Scaffold in Endodontic Regeneration of Immature Anterior Teeth
Non-vital Immature Anterior Teeth
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.
salma khattab, master principal investigator
Minia 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 dental regenerative endodontics in people with Regenerative Endodontics, run by Salma fathy 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 7 inclusion and 5 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 7 Jun 2023. 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?
Pulp sensibility (time frame: Every 3 months over a period of one year). 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?
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 7 Jun 2023.