Necrotic PulpNCT04018456
Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis
A study testing Biodentine and White MTA in people with Necrotic Pulp and Apical Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis. Read more about this study
- Who is it for?
- Ages 10 to 45 years
- Conditions the study is for
- Necrotic Pulp, Apical Periodontitis
- What is being tested?
- Biodentine and White MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Jun 2023
- 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 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
- Negative response of pulp tissue to electrical or thermal pulp tester.
- Widening in lamina dura or periapical radiolucency not more than 3 mm.
Who cannot join
- 1. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.
- 3. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).
- 4. Teeth with previous root canal. 5. Teeth need to post and core as final restoration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial
The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.
Read the detailed description
- Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.
Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.
At the end of treatment, the access cavity will be sealed with composite restoration.
- Conditions
- Necrotic Pulp, Apical Periodontitis
- Being tested
- Biodentine, White MTA
- Keywords
- Necrotic pulp,, Apical periodontitis, Regeneration, MTA, Biodentine
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineOther
Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.
White MTAOther
Also called white mineral trioxide aggregate
MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine | Experimental | Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment. Receives: Other: Biodentine |
| White MTA | Active comparator | Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment. Receives: Other: White MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discoloration of teeth
Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade.
Measured: Up to one Year after completion of regenerative endodontic treatment
Secondary outcomes (2)
Healing of Periapical Tissue
Healing of periapical tissue will be assessed clinically and radiographically through follow up period: 3, 6, 9, 12 months. When the case is clinically asymptomatic: (without sinus tract, swelling, with no palpation, or percussions pain) and radiographically showed absence or reduction of the radiolucency are together will considered successful of regenerative treatment.
Measured: after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Restoring the sensibility of tooth
Electric pulp tester (EPT)
Measured: after 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Aug 2021
- Primary completion1 Jan 2022
- Study completion1 Jun 2023
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 Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amatallah Hussein Nasser Al-Rawhani, Cairo University
- Investigators
- Amatallah HN Al-Rawhani, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018456
- Sponsor's protocol ID
- CU-2019-7-7
- Status last verified
- Jan 2024
- First submitted
- 7 Jul 2019
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.
PubMed 31155298
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial
- ClinicalTrials.gov ID
- NCT04018456
- Acronym / sponsor ID
- CU-2019-7-7
- Conditions
- Necrotic Pulp, Apical Periodontitis
- Keywords
- Necrotic pulp,, Apical periodontitis, Regeneration, MTA, Biodentine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 12 Jul 2019 (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 this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.
Detailed description
- Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.
Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.
At the end of treatment, the access cavity will be sealed with composite restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine | Experimental | Other: BiodentineIntervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment. |
| White MTA | Active comparator | Other: White MTAControl group: application of White MTA as pulp space barrier during regenerative endodontic treatment. |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
- Negative response of pulp tissue to electrical or thermal pulp tester.
- Widening in lamina dura or periapical radiolucency not more than 3 mm.
Key exclusion criteria (3 listed)
- 1. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.
- 3. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).
- 4. Teeth with previous root canal. 5. Teeth need to post and core as final restoration
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 |
|---|---|---|
| BiodentineBiodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material. | Other | Biodentine |
| White MTAAlso: white mineral trioxide aggregateMTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material. | Other | White MTA |
Primary outcome
Discoloration of teeth
Time frame: Up to one Year after completion of regenerative endodontic treatment
Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade.
2 secondary outcomes
Healing of Periapical Tissue
Time frame: after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Restoring the sensibility of tooth
Time frame: after 6,9 and Up to 12 months after completion of regenerative endodontic treatment
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 23 Jan 2024.
- Results publication: PubMed 31155298Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.
- 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.
Amatallah HN Al-Rawhani, Master principal investigator
Cairo 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 Biodentine and White MTA in people with Necrotic Pulp and Apical Periodontitis, run by Cairo 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 3 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: finished, as of the sponsor's last update on 23 Jan 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?
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?
Discoloration of teeth (time frame: Up to one Year after completion of regenerative endodontic treatment). 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 NCT04018456, 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 23 Jan 2024.