Necrotic PulpRCTNCT03083015
Pulp Revascularization Versus MTA Apexification
A study testing revascularization and Apexification in people with Necrotic Pulp, run by Enas Ebrahim Sayed.
Trial summary
This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- revascularization and Apexification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2012to 2 Dec 2015
- 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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.
Who cannot join
- History of allergy to any of the antibiotics in the tri-mix used in the study
- Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,…
- Psychological disturbance
- External / internal root resorption or cystic lesion.
About this study
Official title: A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial
This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.
Read the detailed description
the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.
- Conditions
- Necrotic Pulp
- Being tested
- revascularization, Apexification
- Keywords
- regeneration, MTA apexification and TAP, revascularization
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revascularizationProcedure or surgery
Also called regeneration
a sterile sharp needle was 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
ApexificationProcedure or surgery
a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.
| Study group | Role | What they receive |
|---|---|---|
| Revascularization | Experimental | Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted. Receives: Procedure: revascularization |
| Apexfication | Active comparator | Apexification using grey MTA apically compacted without mechanical preparation. Receives: Procedure: Apexification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measures
self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.
Measured: 2 days
Secondary outcomes (4)
Resolution of periapical pathosis
Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
Measured: 9 months
Amount of radiographic increase in root length:
Root length was measured as a straight line from the cement-enamel junction to the radiographic apex of the tooth in millimeters = (9months follow up length - baseline length)
Measured: baseline and 9 months
Amount of radiographic increase in the root dentinal wall thickness:
Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.
Measured: baseline and 9 months
Decrease of apical diameter:
the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements
Measured: baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start6 Dec 2012
- Primary completion2 Dec 2015
- Study completion2 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies 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
- Model description
- participants are allocated at random to receive one of two interventions according to the research plan. In RCT the outcomes are measured, so it is considered a quantitative study . This trial conforms to the Consolidated Standard of Reporting Trials (CONSORT)statement.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enas Ebrahim Sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enas Ebrahim Sayed, Cairo University
- Investigators
- ahmed alkhadem, lecturer, Principal investigator, evidence based center, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083015
- Sponsor's protocol ID
- Revas1
- Other IDs
- cebd
- Acronym
- RCT
- Status last verified
- Mar 2017
- First submitted
- 7 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16.
PubMed 25443280Alobaid AS, Cortes LM, Lo J, Nguyen TT, Albert J, Abu-Melha AS, Lin LM, Gibbs JL. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study. J Endod. 2014 Aug;40(8):1063-70. doi: 10.1016/j.joen.2014.02.016. Epub 2014 Jun 13.
PubMed 25069909
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03083015
- Acronym / sponsor ID
- RCT / Revas1
- Conditions
- Necrotic Pulp
- Keywords
- regeneration, MTA apexification and TAP, revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Enas Ebrahim SayedUniversity, hospital or other
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- 2 Dec 2015 (actual)
- Study completion
- 2 Dec 2015 (actual)
- First posted
- 17 Mar 2017 (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.
This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.
Detailed description
the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- participants are allocated at random to receive one of two interventions according to the research plan. In RCT the outcomes are measured, so it is considered a quantitative study . This trial conforms to the Consolidated Standard of Reporting Trials (CONSORT)statement.
| Arm | Type | Receives |
|---|---|---|
| Revascularization | Experimental | Procedure: revascularizationBlood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted. |
| Apexfication | Active comparator | Procedure: ApexificationApexification using grey MTA apically compacted without mechanical preparation. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.
Key exclusion criteria (4 listed)
- History of allergy to any of the antibiotics in the tri-mix used in the study
- Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,…
- Psychological disturbance
- External / internal root resorption or cystic lesion.
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 |
|---|---|---|
| revascularizationAlso: regenerationa sterile sharp needle was 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 | Procedure or surgery | Revascularization |
| Apexificationa 3-5 mm thickness of MTA using a hand plugger and was verified radiographically. | Procedure or surgery | Apexfication |
Primary outcome
Pain intensity measures
Time frame: 2 days
self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.
4 secondary outcomes
Resolution of periapical pathosis
Time frame: 9 months
Amount of radiographic increase in root length:
Time frame: baseline and 9 months
Amount of radiographic increase in the root dentinal wall thickness:
Time frame: baseline and 9 months
Decrease of apical diameter:
Time frame: baseline and 9 months
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 21 Mar 2017.
- Results publication: PubMed 25443280Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16.
- Results publication: PubMed 25069909Alobaid AS, Cortes LM, Lo J, Nguyen TT, Albert J, Abu-Melha AS, Lin LM, Gibbs JL. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study. J Endod. 2014 Aug;40(8):1063-70. doi: 10.1016/j.joen.2014.02.016. Epub 2014 Jun 13.
- test linkLink provided by the sponsor.
- test linkLink provided by the sponsor.
- 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.
ahmed alkhadem, lecturer principal investigator
evidence based center, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing revascularization and Apexification in people with Necrotic Pulp, run by Enas Ebrahim Sayed.
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 1 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain intensity measures (time frame: 2 days). 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 NCT03083015, which also lists 2 linked publications.
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 21 Mar 2017.