Pulp Revascularization Versus MTA Apexification (RCT)
Primary Purpose
Necrotic Pulp
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
revascularization
Apexification
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp focused on measuring regeneration, MTA apexification and TAP, revascularization
Eligibility Criteria
Inclusion Criteria:
- Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Revascularization
Apexfication
Arm Description
Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.
Apexification using grey MTA apically compacted without mechanical preparation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Resolution of periapical pathosis
Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
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)
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.
Decrease of apical diameter:
the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03083015
Brief Title
Pulp Revascularization Versus MTA Apexification
Acronym
RCT
Official Title
A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 6, 2012 (Actual)
Primary Completion Date
December 2, 2015 (Actual)
Study Completion Date
December 2, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Enas Ebrahim Sayed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp
Keywords
regeneration, MTA apexification and TAP, revascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
For the allocation concealment mechanism, each of 66 papers (each paper was eight folded) numbered from 1 to 66 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 was to be performed for the patient. The partner was to decide the procedure for the operator according to that number.
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Revascularization
Arm Type
Experimental
Arm Description
Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.
Arm Title
Apexfication
Arm Type
Active Comparator
Arm Description
Apexification using grey MTA apically compacted without mechanical preparation.
Intervention Type
Procedure
Intervention Name(s)
revascularization
Other Intervention Name(s)
regeneration
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Apexification
Intervention Description
a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.
Primary Outcome Measure Information:
Title
Pain intensity measures
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Resolution of periapical pathosis
Description
Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
Time Frame
9 months
Title
Amount of radiographic increase in root length:
Description
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)
Time Frame
baseline and 9 months
Title
Amount of radiographic increase in the root dentinal wall thickness:
Description
Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.
Time Frame
baseline and 9 months
Title
Decrease of apical diameter:
Description
the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements
Time Frame
baseline and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed alkhadem, lecturer
Organizational Affiliation
evidence based center, Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25443280
Citation
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.
Results Reference
result
PubMed Identifier
25069909
Citation
Alobaid 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.
Results Reference
result
Links:
URL
http://dx.doi.org/10.1016/j.joen.2014.08.023
Description
test link
URL
http://dx.doi.org/10.1016/j.joen.2014.02.016
Description
test link
Learn more about this trial
Pulp Revascularization Versus MTA Apexification
We'll reach out to this number within 24 hrs