RegenerationregenerationNCT06693739
Regenerative Ability of Immature Necrotic Permanent Teeth Using Different Scaffolds
A study testing Platelet rich fibrin, hyaluronic acid and no scaffold in people with Regeneration, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare effect of different scaffolds on the regenerative potential of young permanent immature teeth with necrotic pulp. The main question it aims to answer is: is there difference in regenerative potential using Hyaluronic acid and platelets rich fibrin as scaffolds in permanent… Read more about this study
- Who is it for?
- Ages 9 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Regeneration
- What is being tested?
- Platelet rich fibrin, hyaluronic acid and no scaffold
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with age range from 9-20 years with no sex predilection. Systemically healthy patients.
- Non-vital maxillary anterior presenting with or without signs and/or symptoms of periapical pathology.
- No mobility.
- Pocket depth less than 3 mm.
Who cannot join
- Teeth with vertical fracture
- Periodontal involved teeth and non-restorable teeth
- Lack of patient cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regenerative Ability of Immature Necrotic Permanent Teeth Using Different Scaffolds (A Randomized Clinical Trial)
The goal of this clinical trial is to compare effect of different scaffolds on the regenerative potential of young permanent immature teeth with necrotic pulp. The main question it aims to answer is:
is there difference in regenerative potential using Hyaluronic acid and platelets rich fibrin as scaffolds in permanent immature teeth with necrotic pulp? participants will undergo regeneration protocol including hyaluronic acid and platelets rich fibrin as scaffolds Researchers will compare [hyaluronic acid , platelets rich fibrin , and no scaffold ] to see the regenerative potential
Read the detailed description
The study will be conducted on 30 maxillary anterior teeth with open apex; with 10 maxillary anterior teeth with open apex in each group (n=10). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. single blinding will be maintained in this study as the Outcomes Assessor and the patients will not be aware of their group/used scaffold Group (I) control group with no scaffold used. Group (II) using platelets rich fibrin ( PRF) as a scaffold. Group (III) using hyaluronic acid (HYA) as a scaffold.
Procedural steps:
1st visit
1.Patients will be given anesthesia with vasoconstrictor . rubber dam isolation and access will be done 2. gentle irrigation with 1.5-3% sodium hypochlorite (NaOCl) (20ml/5 mins) using needle with closed end and side-vents with needle placed 1mm from apex will be done 3.then, irrigation will be done with saline or 17% Ethylenediaminetetraacetic acid (EDTA) (20 mL/canal, 5 min) 4. The canal space will be dried using sterile paper points 5.1ml of calcium hydroxide (metapaste) will be delivered into canal space 6.Sterile cotton pellet will be inserted and access cavity will be sealed using 3-4mm of temporary restoration (Coltosol F; Coltene Whaledent, Altstatten, Switzerland) for 3 weeks.
2nd visit
- Final visit for three groups will be scheduled when tooth is asymptomatic with no signs of discharge.
- In case of persistent infection one or more visits will be scheduled for discharge and disinfection.
- patient will be anesthetized using 3% mepivacaine without vasoconstrictor, proper isolation will be done, the temporary restoration and cotton pellet will be removed.
- Canal will be irrigated using 17% EDTA (20ml/5mins).
- Canals will be dried using sterile paper points.
- In group (I) A sterile hand file size #50 will be used sharp strokes 2 mm beyond apex into the periapical tissue until bleeding is evident in cervical portion of canal In group (II) For the PRF preparation, 10Ml of the patient's whole blood will be collected in sterile tubes from the cubital vein. The tubes will be centrifuged for 10 minutes with a speed of 3000 rpm . Inside each test tube three layers will be formed: a base layer containing erythrocytes, an intermediate layer of PRF clot, and a surface layer of acellular plasma. The PRF clot will be separated from the other layers and then compressed in a PRF box (Intra-Lock International). The compressed PRF membrane will be rolled over itself to allow its implantation into the canal . The PRF membrane will be inserted inside the root canal and condensed apically with an endodontic hand plugger. In group (III)A sterile hand file size #50 will be used sharp strokes 2 mm beyond apex into the periapical tissue until bleeding is evident in cervical portion of canal then, hyaluronic acid hydrogel will be inserted inside the canal
- MTA plug orifice plug as a capping material will be used to seal canal orifice.
- 3-4 mm layer of glass ionomer (e.g. Fuji IX™, GC America, Alsip, IL) will be flowed gently over the capping material and light-cured for 40 s to seal the access cavity.
- A postoperative standardized periapical radiograph will be taken for baseline records
- After treatment is done patient will be recalled for follow-up every three months for one year.
- Conditions
- Regeneration
- Being tested
- Platelet rich fibrin, hyaluronic acid, no scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinProcedure or surgery
PRF membrane is placed as a scaffold inside the canal with no hyaluronic acid
hyaluronic acidProcedure or surgery
hyaluronic acid gel is placed as a scaffold inside the canal with no PRF
no scaffoldProcedure or surgery
initiate bleeding using hand files size beyond apex with sharp strokes with no PRF or hyaluronic acid placed
| Study group | Role | What they receive |
|---|---|---|
| no scaffold | Active comparator | initiate bleeding using hand files size beyond apex with sharp strokes Receives: Procedure: no scaffold |
| platelets rich fibrin | Experimental | PRF is used as Scaffold by placing the compressed PRF membrane into canal Receives: Procedure: Platelet rich fibrin |
| hyaluronic acid | Experimental | hyaluronic acid will be delivered by syringe into canal Receives: Procedure: hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically by absence of pain and/or swelling
absence of pain is measured clinically by absence of pain in response to percussion and palation in relation to the related tooth
Measured: 1 year
absence or change of periapical radiolucency.
absence or change of periapical radiolucency is measured by standardized radiographs (paralleling technique every 3 months and cbct after 1 year)
Measured: 1 year
Secondary outcomes (1)
measuring different root parameters
using standardized radiographic assessment ( CBCT after 1 year and paralleling technique every 3 months for 1 year ) to assess
- Change in root length in millimeters
- Change in root thickness in millimeters
- Change in apical diameter in millimeters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start20 Dec 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (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 Ain Shams 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Osama, Ain Shams University
- Investigators
- Mai Abdel Raouf, Teaching assistant, Principal investigator, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693739
- Sponsor's protocol ID
- 072030
- Acronym
- regeneration
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dhillon H, Kaushik M, Sharma R. Regenerative endodontics--Creating new horizons. J Biomed Mater Res B Appl Biomater. 2016 May;104(4):676-85. doi: 10.1002/jbm.b.33587. Epub 2015 Dec 24.
PubMed 26699211
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Ability of Immature Necrotic Permanent Teeth Using Different Scaffolds (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06693739
- Acronym / sponsor ID
- regeneration / 072030
- Conditions
- Regeneration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 18 Nov 2024 (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 goal of this clinical trial is to compare effect of different scaffolds on the regenerative potential of young permanent immature teeth with necrotic pulp. The main question it aims to answer is:
is there difference in regenerative potential using Hyaluronic acid and platelets rich fibrin as scaffolds in permanent immature teeth with necrotic pulp? participants will undergo regeneration protocol including hyaluronic acid and platelets rich fibrin as scaffolds Researchers will compare [hyaluronic acid , platelets rich fibrin , and no scaffold ] to see the regenerative potential
Detailed description
The study will be conducted on 30 maxillary anterior teeth with open apex; with 10 maxillary anterior teeth with open apex in each group (n=10). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. single blinding will be maintained in this study as the Outcomes Assessor and the patients will not be aware of their group/used scaffold Group (I) control group with no scaffold used. Group (II) using platelets rich fibrin ( PRF) as a scaffold. Group (III) using hyaluronic acid (HYA) as a scaffold.
Procedural steps:
1st visit
1.Patients will be given anesthesia with vasoconstrictor . rubber dam isolation and access will be done 2. gentle irrigation with 1.5-3% sodium hypochlorite (NaOCl) (20ml/5 mins) using needle with closed end and side-vents with needle placed 1mm from apex will be done 3.then, irrigation will be done with saline or 17% Ethylenediaminetetraacetic acid (EDTA) (20 mL/canal, 5 min) 4. The canal space will be dried using sterile paper points 5.1ml of calcium hydroxide (metapaste) will be delivered into canal space 6.Sterile cotton pellet will be inserted and access cavity will be sealed using 3-4mm of temporary restoration (Coltosol F; Coltene Whaledent, Altstatten, Switzerland) for 3 weeks.
2nd visit
- Final visit for three groups will be scheduled when tooth is asymptomatic with no signs of discharge.
- In case of persistent infection one or more visits will be scheduled for discharge and disinfection.
- patient will be anesthetized using 3% mepivacaine without vasoconstrictor, proper isolation will be done, the temporary restoration and cotton pellet will be removed.
- Canal will be irrigated using 17% EDTA (20ml/5mins).
- Canals will be dried using sterile paper points.
- In group (I) A sterile hand file size #50 will be used sharp strokes 2 mm beyond apex into the periapical tissue until bleeding is evident in cervical portion of canal In group (II) For the PRF preparation, 10Ml of the patient's whole blood will be collected in sterile tubes from the cubital vein. The tubes will be centrifuged for 10 minutes with a speed of 3000 rpm . Inside each test tube three layers will be formed: a base layer containing erythrocytes, an intermediate layer of PRF clot, and a surface layer of acellular plasma. The PRF clot will be separated from the other layers and then compressed in a PRF box (Intra-Lock International). The compressed PRF membrane will be rolled over itself to allow its implantation into the canal . The PRF membrane will be inserted inside the root canal and condensed apically with an endodontic hand plugger. In group (III)A sterile hand file size #50 will be used sharp strokes 2 mm beyond apex into the periapical tissue until bleeding is evident in cervical portion of canal then, hyaluronic acid hydrogel will be inserted inside the canal
- MTA plug orifice plug as a capping material will be used to seal canal orifice.
- 3-4 mm layer of glass ionomer (e.g. Fuji IX™, GC America, Alsip, IL) will be flowed gently over the capping material and light-cured for 40 s to seal the access cavity.
- A postoperative standardized periapical radiograph will be taken for baseline records
- After treatment is done patient will be recalled for follow-up every three months for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no scaffold | Active comparator | Procedure: no scaffoldinitiate bleeding using hand files size beyond apex with sharp strokes |
| platelets rich fibrin | Experimental | Procedure: Platelet rich fibrinPRF is used as Scaffold by placing the compressed PRF membrane into canal |
| hyaluronic acid | Experimental | Procedure: hyaluronic acidhyaluronic acid will be delivered by syringe into canal |
Who may qualify
- Ages
- 9 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with age range from 9-20 years with no sex predilection. Systemically healthy patients.
- Non-vital maxillary anterior presenting with or without signs and/or symptoms of periapical pathology.
- No mobility.
- Pocket depth less than 3 mm.
Key exclusion criteria (3 listed)
- Teeth with vertical fracture
- Periodontal involved teeth and non-restorable teeth
- Lack of patient cooperation
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 |
|---|---|---|
| Platelet rich fibrinPRF membrane is placed as a scaffold inside the canal with no hyaluronic acid | Procedure or surgery | platelets rich fibrin |
| hyaluronic acidhyaluronic acid gel is placed as a scaffold inside the canal with no PRF | Procedure or surgery | hyaluronic acid |
| no scaffoldinitiate bleeding using hand files size beyond apex with sharp strokes with no PRF or hyaluronic acid placed | Procedure or surgery | no scaffold |
Primary outcome
Clinically by absence of pain and/or swelling
Time frame: 1 year
absence of pain is measured clinically by absence of pain in response to percussion and palation in relation to the related tooth
absence or change of periapical radiolucency.
Time frame: 1 year
absence or change of periapical radiolucency is measured by standardized radiographs (paralleling technique every 3 months and cbct after 1 year)
1 secondary outcome
measuring different root parameters
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 26699211Dhillon H, Kaushik M, Sharma R. Regenerative endodontics--Creating new horizons. J Biomed Mater Res B Appl Biomater. 2016 May;104(4):676-85. doi: 10.1002/jbm.b.33587. Epub 2015 Dec 24.
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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.
Mai Abdel Raouf, Teaching assistant principal investigator
Ainshams 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 Platelet rich fibrin, hyaluronic acid and no scaffold in people with Regeneration, run by Ain Shams 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinically by absence of pain and/or swelling (time frame: 1 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?
On the ClinicalTrials.gov record for NCT06693739, 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 20 Nov 2024.