Regeneration of Immature Teeth. Case Series

Revascularization Clinical Trial

Official title:

The Regenerative Potential of Immature Necrotic Teeth With Apical Periodontitis Based on Clinical and Radiographic Assessments

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03507556
• Other study ID #: JordanUST1
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2010
• Est. completion date: December 1, 2030

Study information

• Verified date: February 2020
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically.

Description:

All teeth will be disinfected using either triple antibiotic paste (a mixture of metronidazole, ciprofloxacin and amoxicillin mixed with sterile glycole) or non setting calcium hydroxide applied to the pulp space with a sterile lentulospiral and then closed temporarily with a sterile sponge and temporary restoration for 2-3 weeks to allow disinfection of the canals teeth will be reentered under rubber dam isolation and all intracanal medicaments will be washed out from the canal using 10 ml of 2.5% sodium hypochlorite and 20 ml of Ethylene diamine tetra acetic acid (EDTA). Then, a sterile endodontic file will be inserted past the canal terminus into the periapical tissues to induce bleeding to fill the canal space as much as possible and subsequently sealed with a double coronal seal using bioceramic repair material and composite filling. All the teeth will be monitored clinically and radiographically on a biannual basis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2030
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

Inclusion Criteria:

1. Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.

2. An immature/open apex.

3. Tooth does not need post and core restoration.

4. Medically healthy patients with no known allergy to used materials.

Exclusion Criteria:

1. Medically compromised patient,

2. Teeth with periodontal involvement

3. Teeth with vertical root fractures,

4. Non-restorable teeth,

Related Conditions & MeSH terms

• Revascularization

Intervention

Procedure:
• Triple paste and induced bleeding

Drug:
• Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol
triple paste of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol

Locations

Country	Name	City	State
Jordan	Dental health center	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete healing	Assess clinically and radiographically absence of symptoms and signs. And evidence for continuation of root development	from start of intervention up to 100 months.