Incomplete Root Formation of Anterior TeethNCT05803525
Efficacy of Combined Scaffolds and Sodium Hypochlorite in Regenerative Endodontics of Immature Teeth
A study testing Intra-canal medication protocol in people with Incomplete Root Formation of Anterior Teeth, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the efficacy of combinations of different scaffolds (blood clot, platelet rich fibrin, collagen) and sodium hypochlorite concentrations (0.5%- 2.5%) in regenerative endodontics of immature non-vital anterior teeth clinically and radiographically using cone-beam computed tomography. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Incomplete Root Formation of Anterior Teeth
- What is being tested?
- Intra-canal medication protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 30 Jan 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Patients, abarantly free from any systemic diseases that may hinder the normal healing process.
- Maxillary traumatized or cariously exposed immature anterior teeth.
- Clinical signs of pulp necrosis.
- Radiographic evidence of incomplete root development based on an apical opening >1 mm.
Who cannot join
- • Allergy to medication used in the procedure or any medical conditions that contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense).
- Non-restorable tooth.
- Radiographic evidence of root fracture.
- Lack of patient and parent cooperation.
- Teeth with vital pulps and complete root development.
- Presence of periodontal pocket > 4 mm.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Tanta University
Tanta
Hanan Arb
About this study
Official title: كفاءة الدعامات و هيبوكلوريت الصوديوم مجتمعة في التجديد اللبى للأسنان الغير مكتملة
The aim of the study is to evaluate the efficacy of combinations of different scaffolds (blood clot, platelet rich fibrin, collagen) and sodium hypochlorite concentrations (0.5%- 2.5%) in regenerative endodontics of immature non-vital anterior teeth clinically and radiographically using cone-beam computed tomography.
Read the detailed description
Patients will be divided randomly into six equal groups (n=8)
- Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution.
- Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution.
- Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.
CBCT image will be obtained for baseline records after placement of the final resin restoration then the patients will be recalled after 6 months and 12 months for evaluating any changes in root length, root canal width, apex diameter and lesion size if present. The success rates for patients at each recall visit will be scored as follows
- Score 0: Persistence of clinical and radiographic findings.
- Score 1: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + no evidence of increased root dimensions.
- Score 2: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + radiographic root development.
- Being tested
- Intra-canal medication protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-canal medication protocolOther
Copious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline.
After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points.
| Study group | Role | What they receive |
|---|---|---|
| • Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution. | Active comparator | BC will be made \& use 0.5 NaOCl conc Receives: Other: Intra-canal medication protocol |
| • Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution. • | Active comparator | BC will be made \& use 2.5 NaOCl conc Receives: Other: Intra-canal medication protocol |
| • Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution. • | Active comparator | PRF will be made \& use 0.5 NaOCl conc Receives: Other: Intra-canal medication protocol |
| Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution. • | Active comparator | PRF will be made \& use 2.5 NaOCl conc Receives: Other: Intra-canal medication protocol |
| • Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution. | Active comparator | Collagen will be made \& use 0.5 NaOCl conc Receives: Other: Intra-canal medication protocol |
| • Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution. | Active comparator | Collagen will be made \& use 2.5 NaOCl conc Receives: Other: Intra-canal medication protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
diameter of periapical radiolucency
radiographic changes in root
Measured: 1 year
diameter of root length
radiographic changes in root
Measured: 1 year
Secondary outcomes (2)
Pain scale
Measured: 1 year
visual changes in discoloration
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 posted7 Apr 2023
- Study start15 Jan 2020
- Primary completion15 Aug 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Root Formation of Anterior TeethStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Mohamed Arb, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803525
- Sponsor's protocol ID
- HananArb
- Status last verified
- Mar 2023
- First submitted
- 10 Dec 2022
- Last updated
- 7 Apr 2023
- Results posted
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- كفاءة الدعامات و هيبوكلوريت الصوديوم مجتمعة في التجديد اللبى للأسنان الغير مكتملة
- ClinicalTrials.gov ID
- NCT05803525
- Acronym / sponsor ID
- HananArb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 7 Apr 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.
The aim of the study is to evaluate the efficacy of combinations of different scaffolds (blood clot, platelet rich fibrin, collagen) and sodium hypochlorite concentrations (0.5%- 2.5%) in regenerative endodontics of immature non-vital anterior teeth clinically and radiographically using cone-beam computed tomography.
Detailed description
Patients will be divided randomly into six equal groups (n=8)
- Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution.
- Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution.
- Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.
- Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.
CBCT image will be obtained for baseline records after placement of the final resin restoration then the patients will be recalled after 6 months and 12 months for evaluating any changes in root length, root canal width, apex diameter and lesion size if present. The success rates for patients at each recall visit will be scored as follows
- Score 0: Persistence of clinical and radiographic findings.
- Score 1: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + no evidence of increased root dimensions.
- Score 2: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + radiographic root development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| • Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution. | Active comparator | Other: Intra-canal medication protocolBC will be made \& use 0.5 NaOCl conc |
| • Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution. • | Active comparator | Other: Intra-canal medication protocolBC will be made \& use 2.5 NaOCl conc |
| • Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution. • | Active comparator | Other: Intra-canal medication protocolPRF will be made \& use 0.5 NaOCl conc |
| Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution. • | Active comparator | Other: Intra-canal medication protocolPRF will be made \& use 2.5 NaOCl conc |
| • Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution. | Active comparator | Other: Intra-canal medication protocolCollagen will be made \& use 0.5 NaOCl conc |
| • Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution. | Active comparator | Other: Intra-canal medication protocolCollagen will be made \& use 2.5 NaOCl conc |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients, abarantly free from any systemic diseases that may hinder the normal healing process.
Key exclusion criteria (6 listed)
- • Allergy to medication used in the procedure or any medical conditions that contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense).
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 |
|---|---|---|
| Intra-canal medication protocolCopious gentle irrigation will be provided without canal instrumentation using 20 mL 1.5% NaOCl in a slow flowing rate by a 27-gauge irrigating side vented needle positioned 2 mm from the root end followed by 20 mL saline. After root canal dryness using paper points , double antibiotic paste (DAP) containing 500 mg of metronidazole and ciprofloxacin mixed with 0.5 mL polypropylene glycol giving a creamy paste will transported into root canal via lentulo spiral filler positioned 2 mm shorter than the WL apically and to level just below the cement-enamel junction (CEJ) coronally. Access cavity will be sealed response to the initial treatment will be assessed after 3 weeks.(21) In the next visit, If the patient is asymptomatic, the DAP will be removed using 10 mL of NaOCl according to the concentrations mentioned in each study group, followed by copious irrigation with 10 mL of 17% EDTA (22) and normal saline then drying the canals with sterile paper points. | Other | Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution. •, • Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution., • Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution. •, • Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution. •, • Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution., • Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution. |
Primary outcome
diameter of periapical radiolucency
Time frame: 1 year
radiographic changes in root
diameter of root length
Time frame: 1 year
radiographic changes in root
2 secondary outcomes
Pain scale
Time frame: 1 year
visual changes in discoloration
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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 Intra-canal medication protocol in people with Incomplete Root Formation of Anterior Teeth, run by Tanta 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 6 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 7 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Arb, M.S.D (01066742826 ext. +02, hanobasha_7424@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diameter of periapical radiolucency (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?
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 Apr 2023.