Pulp Revascularization Versus MTA Apexification

Necrotic Pulp Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083015
• Other study ID #: Revas1
• Secondary ID: cebd
• Status: Completed
• Phase: N/A
• First received: March 7, 2017
• Last updated: March 19, 2017
• Start date: December 6, 2012
• Est. completion date: December 2, 2015

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2, 2015
• Est. primary completion date: December 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp

Intervention

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
• Apexification
a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Enas Ebrahim Sayed

References & Publications (2)

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; — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Resolution of periapical pathosis	Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.	9 months
Secondary	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
Secondary	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
Secondary	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

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