Regeneration of Immature Teeth. Case Series

Not Applicable

Active, not recruiting

• Conditions: Revascularization
• Interventions: Procedure: Triple paste and induced bleeding; Drug: Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol

• Registration Number: NCT03507556
• Lead Sponsor: Jordan University of Science and Technology

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-06-28
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-25
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25
• Primary Completion: 2021-11
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triple paste and induced bleeding	Triple paste and induced bleeding	The triple paste is a mixture of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol will be used and next visit intracanal bleeding will be induced
Triple paste and induced bleeding	Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol	The triple paste is a mixture of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol will be used and next visit intracanal bleeding will be induced

Primary Outcome Measures

Name	Time	Method
complete healing	from start of intervention up to 100 months.	Assess clinically and radiographically absence of symptoms and signs. And evidence for continuation of root development

Trial Locations

Locations (1)

Dental health center; 🇯🇴 Irbid, Jordan