Pulp Revascularization Versus MTA Apexification (RCT)

March 19, 2017 updated by: Enas Ebrahim Sayed

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of periapical pathosis
Time Frame: 9 months
Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
9 months
Amount of radiographic increase in root length:
Time Frame: baseline and 9 months
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:
Time Frame: baseline and 9 months
Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.
baseline and 9 months
Decrease of apical diameter:
Time Frame: baseline and 9 months
the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements
baseline and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enas Ebrahim Sayed

Investigators

  • Principal Investigator: ahmed alkhadem, lecturer, evidence based center, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2012

Primary Completion (Actual)

December 2, 2015

Study Completion (Actual)

December 2, 2015

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 19, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Revas1
  • cebd (Other Identifier: center of evidence based/cu)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Necrotic Pulp

Clinical Trials on revascularization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe