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NCT Number: NCT03507556

Regeneration of Immature Teeth. Case Series

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental health center

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.
  • An immature/open apex.
  • Tooth does not need post and core restoration.
  • Medically healthy patients with no known allergy to used materials.

Exclusion criteria

  • Medically compromised patient,
  • Teeth with periodontal involvement
  • Teeth with vertical root fractures,
  • Non-restorable teeth,

Treatment and study plan

Triple paste and induced bleeding

Procedure

Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol

Drug

triple paste of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol

Primary outcomes

  1. complete healing

    Time frame: from start of intervention up to 100 months.

    Assess clinically and radiographically absence of symptoms and signs. And evidence for continuation of root development

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2030
First posted
Apr 25, 2018
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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