RCT: Pulp Revascularization Versus MTA Apexification

Sponsor

Enas Ebrahim Sayed (Other)

Overall Status

Completed

CT.gov ID

NCT03083015

Collaborator

(none)

Enrollment

Arms

35.8

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Necrotic Pulp	Procedure: revascularization Procedure: Apexification	N/A

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

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 6, 2012

Actual Primary Completion Date :

Dec 2, 2015

Actual Study Completion Date :

Dec 2, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain intensity measures [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.

Secondary Outcome Measures

Resolution of periapical pathosis [9 months]
Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
Amount of radiographic increase in root length: [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)
Amount of radiographic increase in the root dentinal wall thickness: [baseline and 9 months]
Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.
Decrease of apical diameter: [baseline and 9 months]
the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Enas Ebrahim Sayed

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Enas Ebrahim Sayed, Dentist at ministry of health, Cairo University

ClinicalTrials.gov Identifier:

NCT03083015

Other Study ID Numbers:

Revas1
cebd

First Posted:

Mar 17, 2017

Last Update Posted:

Mar 21, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Enas Ebrahim Sayed, Dentist at ministry of health, Cairo University

regeneration, MTA apexification and TAP

revascularization

Additional relevant MeSH terms:

Dental Pulp Necrosis

Necrosis

Study Results

No Results Posted as of Mar 21, 2017