Immature Permanent Teeth With Open ApexNCT07123597
Effect of Thickness Variation in Coronal Plug on Root Maturation and Periapical Healing
A study testing 5mm bioceramic putty coronal plug and 3mm bioceramic putty coronal plug in people with Immature Permanent Teeth With Open Apex, run by Rania ElSayed Soliman at 1 site in Egypt.
Trial summary
d. Second visit: After 3 weeks the patients will be randomly divided into 2 groups: Group A: Patients will be anesthetized 1 carpule of mepivacaine without vasoconstrictor (Mepivacaine HCl 3%), the access will be reopened under rubber dam isolation and the canal will be irrigated with a total of 20 ml of 1.5-2.5%… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Immature Permanent Teeth With Open Apex
- What is being tested?
- 5mm bioceramic putty coronal plug and 3mm bioceramic putty coronal plug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2022to 30 Jun 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients were medically free [American Society of Anesthesiologists (ASA) Class I or II].
- Age ranging between 10-18 years old.
- No sex predilection.
- Patients having asymptomatic and/or symptomatic immature necrotic anterior teeth.
Who cannot join
- Patients with a history of allergy to any of the material used in the study.
- Patients with systemic diseases (e.g. diabetes mellitus, bleeding disorders, heart diseases, liver diseases, kidney diseases, genetic disorders and syndromes).
- Psychologically disturbed patients.
- Teeth that needed a post and core as the final restoration.
- Patients who had teeth with periodontal pockets more than 3 mm or generalized chronic periodontitis
- Teeth with developmental anomalies (i.e., dens invaginatus or a palatogingival groove)
- Patients who had radiographic evidence of external / internal root resorption or cystic lesion.
- Patients refused participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
- Second visit:
After 3 weeks the patients will be randomly divided into 2 groups:
Read more
Group A:
Patients will be anesthetized 1 carpule of mepivacaine without vasoconstrictor (Mepivacaine HCl 3%), the access will be reopened under rubber dam isolation and the canal will be irrigated with a total of 20 ml of 1.5-2.5% sodium hypochlorite solution. The canal will then be dried with sterile paper points; a sterile sharp needle will be used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process.
Over a 15-minute time period, the blood will be allowed to clot to a level of 3 mm below the cemento-enamel junction. A resorbable matrix such as CollaPlug™, Collacote™, CollaTape™ will be placed over the blood clot if necessary. Then 3 mm of MTA will be placed using a suitable size amalgam carrier. A damped cotton pellet on a tweezer placed above the unset MTA and large condenser will be used to seal the canal orifice completely. The access cavity will be sealed with Fuji IX glass ionomer filling material and acid etched composite resin bonded filling material.
Group B:
The same procedures that will be followed in group A will be also done in group B, except for the thickness of MTA coronal plug which will be 5mm in its thickness
- Follow-up:
The patients will be recalled after 1, 6 and 12 months for follow up. The post-treatment follow-up examination will be accomplished as follows:
- CBCT scan will be done at 6 and 12 months follow up appointments.
- An evaluation was performed on each patient to assess presence of any signs and symptoms clinically by inspection, percussion, palpation, or biting on the treated tooth.
Read the detailed description
4.1. Trial Design: The trial design of this study is a prospective, 2-arm, 1:1, parallel, randomized, clinical trial (RCT). In RCT, participants are allocated at random to receive one of several interventions according to the research plan created by the investigators. These interventions may be drug, placebo or certain procedure which is not usually known whether it will be helpful, harmful or with no difference than the available alternatives. In RCT the outcomes are measured, so it is considered a quantitative study. This trial design methodology conforms to the Consolidated Standard of Reporting Trials (CONSORT).
4.2. Participants:
- Sample size: Teen participants will be selected from the out patients of the endodontic clinic Faculty of dentistry, Ain Shams University), 9 cases in each group .
4.3. Randomization: Randomization is a process that assigns research participants by chance, rather than by choice, to either the experimental group or the control group. The goal of randomization is to produce comparable groups in terms of general participant characteristics, such as age, gender, chief complain, time pass after trauma, and the other key factors that affect the probable course the disease would take. In this way, the 2 groups are as similar as possible at the start of the study. At the end of the study, if one group has better outcome than the other, the investigators would be able to conclude with some confidence that one intervention is better than the other.
Randomization process was achieved in three steps:
- Sequence generation: Sequence generation will be done for the patient's number (from 1 to 10) using computer sequence generation (www.random.org) which will give a table for group A and group B with randomized patient's numbers (5 number in each group).
- Allocation concealment mechanism: It is a procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient participated in the study. For the allocation concealment mechanism, each of 10 papers (each paper was eight folded) numbered from 1 to 10 were, individually packed, in opaque envelopes. Each participant picked an envelope at the beginning of the second visit. The number in the envelope determined which procedure will be performed to the patient. The partner will decide the procedure for the operator according to that number.
- Implementation:
The random allocation sequence will be done in the Center of The Evidence Based Dentistry, Faculty of Oral and Dental Medicine, Ain Shams University. However, allocation concealment and participant assignment to the intervention will be done by the other investigator.
4.4. Blinding (Masking): Double blinded (Patient and Assessor). Patient will not informed what procedure he/she was subjected to. Assessor will be blinded to the intervention applied on the patient (during pain and swelling assessment).
4.5. Intervention:
Preoperative CBCT scan:
A preoperative CBCT scan will be done to all cases with a high resolution Cone Beam Computed Tomography machine (Planmeca ProMax 3d MID; Planmeca, Helsinki, Finland), with endodontic mode, operating at 90 KV, 12mA with a voxel dimension of 75μm.
In this study 18 patients will be randomly divided into 2 groups (9 patients per each group), where treatment will be completed in 2 visits.
First visit:
A calcium hydroxide intracanal medicament will be utilized in all teeth of both groups.
Second visit:
Group A: Teeth will be treated by regenerative endodontic procedures with placing of 3mm MTA coronal plug .
Group B: Teeth will be treated by regenerative endodontic procedures with placing of 5mm MTA coronal plug.
- Conditions
- Immature Permanent Teeth With Open Apex
- Being tested
- 5mm bioceramic putty coronal plug, 3mm bioceramic putty coronal plug
- Keywords
- regenerative endodontics, root maturation, periapical healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mm bioceramic putty coronal plugOther
Teeth will be treated by regenerative endodontic procedures with placing of 5mm bioceramic putty coronal plug.
3mm bioceramic putty coronal plugOther
Teeth will be treated by regenerative endodontic procedures with placing of 3mm bioceramic putty coronal plug.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: Teeth will be treated by regenerative endodontic procedures with placing of 5mm coronal plug. Receives: Other: 5mm bioceramic putty coronal plug |
| Group B | Experimental | Group B: Teeth will be treated by regenerative endodontic procedures with placing of 3mm coronal plug. Receives: Other: 3mm bioceramic putty coronal plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root maturation
after superimposition of the pre and post operative CBCT percentage growth of the root was calculated after
- measuring the root length in millimeter in the pre and post operative CBCT increase in length = (follow up length - base line length).
- Amount of radiographic increase in the root dentinal wall thickness Dentin thickness in the post operative CBCT = (root thickness-pulp space) and was compared to the baseline CBCT radiograph. The increase in thickness was calculated as follows: increase in thickness = (follow-up thickness -base line thickness).
- measuring the decrease of apical diameter: Using the preset measurement scale, the diameter of the apical foramen was measured in millimeters on the 12 months follow up CBCT radiograph and was compared to the baseline CBCT radiograph (decrease of apical diameter = follow-up apical diameter-base line apical diameter).
Measured: after 12 month
Secondary outcomes (1)
periapical healing
- Clinically: By visual inspection of the patient's soft tissue at 1, 3, 6 and 12 months (Swelling). When the case is symptoms-free, i.e., without sinus tract swelling, pain on palpation, or percussions, the case is considered a success.
- Radiographically:
Measuring of the total lesion volume on the 12 months follow up CBCT radiograph and compared to the baseline CBCT radiograph.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start3 Jul 2022
- Primary completion6 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immature Permanent Teeth With Open ApexStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania ElSayed Soliman
- Sponsor type
- University, hospital or other
- Collaborators
- Benha National University
- Responsible party
- Sponsor-investigator, Rania ElSayed Soliman, Benha National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123597
- Sponsor's protocol ID
- Regenerative Endodontics
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: photographs, radiographs, age, sex, general health condition
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thickness Variation in Coronal Plug on Root Maturation and Periapical Healing
- ClinicalTrials.gov ID
- NCT07123597
- Acronym / sponsor ID
- Regenerative Endodontics
- Conditions
- Immature Permanent Teeth With Open Apex
- Keywords
- regenerative endodontics, root maturation, periapical healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rania ElSayed SolimanUniversity, hospital or other
- Collaborators
- Benha National University
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 Aug 2025 (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.
- Second visit:
After 3 weeks the patients will be randomly divided into 2 groups:
Group A:
Patients will be anesthetized 1 carpule of mepivacaine without vasoconstrictor (Mepivacaine HCl 3%), the access will be reopened under rubber dam isolation and the canal will be irrigated with a total of 20 ml of 1.5-2.5% sodium hypochlorite solution. The canal will then be dried with sterile paper points; a sterile sharp needle will be used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process.
Over a 15-minute time period, the blood will be allowed to clot to a level of 3 mm below the cemento-enamel junction. A resorbable matrix such as CollaPlug™, Collacote™, CollaTape™ will be placed over the blood clot if necessary. Then 3 mm of MTA will be placed using a suitable size amalgam carrier. A damped cotton pellet on a tweezer placed above the unset MTA and large condenser will be used to seal the canal orifice completely. The access cavity will be sealed with Fuji IX glass ionomer filling material and acid etched composite resin bonded filling material.
Group B:
The same procedures that will be followed in group A will be also done in group B, except for the thickness of MTA coronal plug which will be 5mm in its thickness
- Follow-up:
The patients will be recalled after 1, 6 and 12 months for follow up. The post-treatment follow-up examination will be accomplished as follows:
- CBCT scan will be done at 6 and 12 months follow up appointments.
- An evaluation was performed on each patient to assess presence of any signs and symptoms clinically by inspection, percussion, palpation, or biting on the treated tooth.
Detailed description
4.1. Trial Design: The trial design of this study is a prospective, 2-arm, 1:1, parallel, randomized, clinical trial (RCT). In RCT, participants are allocated at random to receive one of several interventions according to the research plan created by the investigators. These interventions may be drug, placebo or certain procedure which is not usually known whether it will be helpful, harmful or with no difference than the available alternatives. In RCT the outcomes are measured, so it is considered a quantitative study. This trial design methodology conforms to the Consolidated Standard of Reporting Trials (CONSORT).
4.2. Participants:
- Sample size: Teen participants will be selected from the out patients of the endodontic clinic Faculty of dentistry, Ain Shams University), 9 cases in each group .
4.3. Randomization: Randomization is a process that assigns research participants by chance, rather than by choice, to either the experimental group or the control group. The goal of randomization is to produce comparable groups in terms of general participant characteristics, such as age, gender, chief complain, time pass after trauma, and the other key factors that affect the probable course the disease would take. In this way, the 2 groups are as similar as possible at the start of the study. At the end of the study, if one group has better outcome than the other, the investigators would be able to conclude with some confidence that one intervention is better than the other.
Randomization process was achieved in three steps:
- Sequence generation: Sequence generation will be done for the patient's number (from 1 to 10) using computer sequence generation (www.random.org) which will give a table for group A and group B with randomized patient's numbers (5 number in each group).
- Allocation concealment mechanism: It is a procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient participated in the study. For the allocation concealment mechanism, each of 10 papers (each paper was eight folded) numbered from 1 to 10 were, individually packed, in opaque envelopes. Each participant picked an envelope at the beginning of the second visit. The number in the envelope determined which procedure will be performed to the patient. The partner will decide the procedure for the operator according to that number.
- Implementation:
The random allocation sequence will be done in the Center of The Evidence Based Dentistry, Faculty of Oral and Dental Medicine, Ain Shams University. However, allocation concealment and participant assignment to the intervention will be done by the other investigator.
4.4. Blinding (Masking): Double blinded (Patient and Assessor). Patient will not informed what procedure he/she was subjected to. Assessor will be blinded to the intervention applied on the patient (during pain and swelling assessment).
4.5. Intervention:
Preoperative CBCT scan:
A preoperative CBCT scan will be done to all cases with a high resolution Cone Beam Computed Tomography machine (Planmeca ProMax 3d MID; Planmeca, Helsinki, Finland), with endodontic mode, operating at 90 KV, 12mA with a voxel dimension of 75μm.
In this study 18 patients will be randomly divided into 2 groups (9 patients per each group), where treatment will be completed in 2 visits.
First visit:
A calcium hydroxide intracanal medicament will be utilized in all teeth of both groups.
Second visit:
Group A: Teeth will be treated by regenerative endodontic procedures with placing of 3mm MTA coronal plug .
Group B: Teeth will be treated by regenerative endodontic procedures with placing of 5mm MTA coronal plug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: 5mm bioceramic putty coronal plugGroup A: Teeth will be treated by regenerative endodontic procedures with placing of 5mm coronal plug. |
| Group B | Experimental | Other: 3mm bioceramic putty coronal plugGroup B: Teeth will be treated by regenerative endodontic procedures with placing of 3mm coronal plug. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All patients were medically free [American Society of Anesthesiologists (ASA) Class I or II].
- Age ranging between 10-18 years old.
- No sex predilection.
- Patients having asymptomatic and/or symptomatic immature necrotic anterior teeth.
Key exclusion criteria (8 listed)
- Patients with a history of allergy to any of the material used in the study.
- Patients with systemic diseases (e.g. diabetes mellitus, bleeding disorders, heart diseases, liver diseases, kidney diseases, genetic disorders and syndromes).
- Psychologically disturbed patients.
- Teeth that needed a post and core as the final restoration.
- Patients who had teeth with periodontal pockets more than 3 mm or generalized chronic periodontitis
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 |
|---|---|---|
| 5mm bioceramic putty coronal plugTeeth will be treated by regenerative endodontic procedures with placing of 5mm bioceramic putty coronal plug. | Other | Group A |
| 3mm bioceramic putty coronal plugTeeth will be treated by regenerative endodontic procedures with placing of 3mm bioceramic putty coronal plug. | Other | Group B |
Primary outcome
Root maturation
Time frame: after 12 month
after superimposition of the pre and post operative CBCT percentage growth of the root was calculated after 1. measuring the root length in millimeter in the pre and post operative CBCT increase in length = (follow up length - base line length). 2. Amount of radiographic increase in the root dentinal wall thickness Dentin thickness in the post operative CBCT = (root thickness-pulp space) and was compared to the baseline CBCT radiograph. The increase in thickness was calculated as follows: increase in thickness = (follow-up thickness -base line thickness). 3. measuring the decrease of apical diameter: Using the preset measurement scale, the diameter of the apical foramen was measured in millimeters on the 12 months follow up CBCT radiograph and was compared to the baseline CBCT radiograph (decrease of apical diameter = follow-up apical diameter-base line apical diameter).
1 secondary outcome
periapical healing
Time frame: 12 month
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 29 Aug 2025.
- Individual participant dataSharing planned: Yes. photographs, radiographs, age, sex, general health condition
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5mm bioceramic putty coronal plug and 3mm bioceramic putty coronal plug in people with Immature Permanent Teeth With Open Apex, run by Rania ElSayed Soliman 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 8 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 29 Aug 2025. 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?
Root maturation (time frame: after 12 month). 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 29 Aug 2025.