Pulp and Periapical Tissue DiseaseNCT05098483
Regenerative Endodontics for Non-vital Primary Molars
A study testing Regeneration in primary molars by using MTA, Regeneration in primary molars by using biodentine and Conventional Root canal treatment in primary molars in people with Pulp and Periapical Tissue Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp and Periapical Tissue Disease
- What is being tested?
- Regeneration in primary molars by using MTA, Regeneration in primary molars by using biodentine and Conventional Root canal treatment in primary molars
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2023to 26 Oct 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non-vital mandibular primary second molar.
- Restorable tooth
Who cannot join
- Patients allergic to medicaments or antibiotics necessary to complete the procedure.
- Special Health Care Needs
- Excessive mobility
- Presence of internal or external root resorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Regenerative Endodontics Using MTA and Biodentine for Non-vital Primary Molars Compared to Conventional Root Canal Treatment. (A Randomized Controlled Clinical Trial)
Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold
Read the detailed description
Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups:
Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months
- Conditions
- Pulp and Periapical Tissue Disease
- Being tested
- Regeneration in primary molars by using MTA, Regeneration in primary molars by using biodentine, Conventional Root canal treatment in primary molars
- Keywords
- Regenerative endodontic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regeneration in primary molars by using MTAProcedure or surgery
Regenerative endodontic procedure in nonvital primary molars using MTA capping material
Regeneration in primary molars by using biodentineProcedure or surgery
Regenerative endodontic treatment in primary molars with biodentine as capping material
Conventional Root canal treatment in primary molarsProcedure or surgery
Removal of pulp tissue from the canals of primary molars
| Study group | Role | What they receive |
|---|---|---|
| Conventional root canal treatment | Active comparator | The caries will be removed. An excavator will be used to remove the coronal portion of the dental pulp while the radicular portion will be cleaned using k- files. 2.5% Sodium hypochlorite will be used as irrigant solution.The canals will be filled with ZOE cement and a stainless-steel crown will be inserted to restore the tooth. Receives: Procedure: Conventional Root canal treatment in primary molars |
| Regenerative endodontic treatment using MTA | Experimental | Access cavity will be prepared in each primary molar then each canal will be copiously irrigated by sodium hypochlorite. Triple antibiotic paste will be inserted in eash canal then sealed with temporary restoration till the second visit.
In the second visit canals will be irrigated with EDTA, after that induction of bleeding will be created by overinstumentation inside each canal. Finally sealed with MTA under the GIC restoration and S.S.C Receives: Procedure: Regeneration in primary molars by using MTA |
| Regenerative endodontic treatment using Biodentine | Experimental | Access cavity will be prepared in each primary molar then canals will be copiously irrigated by sodium hypochlorite. Mixture of Triple antibiotic paste will be introduced in eash canal then cavity will be sealed with temporary restoration till the second visit.
In the second visit canals will be irrigated with EDTA, after that bleeding will be created by overinstumentation inside each canal. Finally sealed with biodentine under the GIC restoration and S.S.C Receives: Procedure: Regeneration in primary molars by using biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical measures
39 children with no pain or swelling (i.e) successful outcomes
Measured: 12 months
Radiographic measures
39 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start5 Sep 2023
- Primary completion26 Oct 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp and Periapical Tissue DiseaseStudies 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
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Hasaballah, Ain Shams University
- Investigators
- Mai Hasaballah, Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098483
- Sponsor's protocol ID
- Ain-Shams-University
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2021
- Last updated
- 1 Jul 2025
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Regenerative Endodontics Using MTA and Biodentine for Non-vital Primary Molars Compared to Conventional Root Canal Treatment. (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05098483
- Acronym / sponsor ID
- Ain-Shams-University
- Conditions
- Pulp and Periapical Tissue Disease
- Keywords
- Regenerative endodontic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 28 Oct 2021 (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.
Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold
Detailed description
Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups:
Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional root canal treatment | Active comparator | Procedure: Conventional Root canal treatment in primary molarsThe caries will be removed. An excavator will be used to remove the coronal portion of the dental pulp while the radicular portion will be cleaned using k- files. 2.5% Sodium hypochlorite will be used as irrigant solution.The canals will be filled with ZOE cement and a stainless-steel crown will be inserted to restore the tooth. |
| Regenerative endodontic treatment using MTA | Experimental | Procedure: Regeneration in primary molars by using MTAAccess cavity will be prepared in each primary molar then each canal will be copiously irrigated by sodium hypochlorite. Triple antibiotic paste will be inserted in eash canal then sealed with temporary restoration till the second visit. In the second visit canals will be irrigated with EDTA, after that induction of bleeding will be created by overinstumentation inside each canal. Finally sealed with MTA under the GIC restoration and S.S.C |
| Regenerative endodontic treatment using Biodentine | Experimental | Procedure: Regeneration in primary molars by using biodentineAccess cavity will be prepared in each primary molar then canals will be copiously irrigated by sodium hypochlorite. Mixture of Triple antibiotic paste will be introduced in eash canal then cavity will be sealed with temporary restoration till the second visit. In the second visit canals will be irrigated with EDTA, after that bleeding will be created by overinstumentation inside each canal. Finally sealed with biodentine under the GIC restoration and S.S.C |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Non-vital mandibular primary second molar.
- Restorable tooth
Key exclusion criteria (4 listed)
- Patients allergic to medicaments or antibiotics necessary to complete the procedure.
- Special Health Care Needs
- Excessive mobility
- Presence of internal or external root resorption.
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 |
|---|---|---|
| Regeneration in primary molars by using MTARegenerative endodontic procedure in nonvital primary molars using MTA capping material | Procedure or surgery | Regenerative endodontic treatment using MTA |
| Regeneration in primary molars by using biodentineRegenerative endodontic treatment in primary molars with biodentine as capping material | Procedure or surgery | Regenerative endodontic treatment using Biodentine |
| Conventional Root canal treatment in primary molarsRemoval of pulp tissue from the canals of primary molars | Procedure or surgery | Conventional root canal treatment |
Primary outcome
Clinical measures
Time frame: 12 months
39 children with no pain or swelling (i.e) successful outcomes
Radiographic measures
Time frame: 12 months
39 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome
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 1 Jul 2025.
- Individual participant dataSharing planned: No
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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 Hasaballah 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 Regeneration in primary molars by using MTA, Regeneration in primary molars by using biodentine and Conventional Root canal treatment in primary molars in people with Pulp and Periapical Tissue Disease, 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 2 inclusion and 4 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 1 Jul 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?
Clinical measures (time frame: 12 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?
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 1 Jul 2025.