Pulp Revascularization Versus MTA Apexification

Study Overview
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Brief Summary
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This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.

Detailed Description
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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.

Official Title
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A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial

Conditions
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Necrotic Pulp

Intervention / Treatment
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* Procedure: revascularization
* Procedure: Apexification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revascularization<br>Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted. | Procedure: revascularization<br>* 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<br>* Other names: regeneration;|
| Active Comparator: Apexfication<br>Apexification using grey MTA apically compacted without mechanical preparation. | Procedure: Apexification<br>* a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of periapical pathosis | Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph. | 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) | 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. | 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 | baseline and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regeneration, MTA apexification and TAP, revascularization