Pulp Revascularization Versus MTA Apexification

Not Applicable

Completed

• Conditions: Necrotic Pulp
• Interventions: Procedure: revascularization; Procedure: Apexification

• Registration Number: NCT03083015
• Lead Sponsor: Enas Ebrahim Sayed

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.

Study Timeline

• Study Start: 2012-12-06
• Primary Completion: 2015-12-02
• Study Completion: 2015-12-02
• Status Verified: 2017-03
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-17
• Last Update Submitted: 2017-03-19
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revascularization	revascularization	Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.
Apexfication	Apexification	Apexification using grey MTA apically compacted without mechanical preparation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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)
Resolution of periapical pathosis	9 months	Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
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.