Endodontically Treated Teeth Clinical Trial
Official title:
A Prospective Clinical Study of Regenerative Endodontic Treatment of Traumatised Non-vital Immature Teeth Using Bi-antibiotic Paste
Verified date | February 2017 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim: The aim of this prospective study was to evaluate the treatment outcomes of regenerative endodontic technique (RET) for the management of traumatised non-vital immature teeth in children. Methodology: This study aims to recruit 25-30 healthy children with traumatised non-vital immature upper incisors to be treated with bi-antibiotic regenerative endodontic technique. Patients will be reviewed clinically at 3m,6m,9m,12m,2y,and 3 years and radiographically at 3m,9m, 2y,and 3 years. One operator will undertake all treatments, clinical reviews and standardised radiographic exposures. Radiographic analysis will be carried out by two calibrated experienced clinicians. Standardised photographs will be taken at 3m,12m,2y,and 3 years and crown colour changes will be assessed using a standardised validated methodology.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 1, 2017 |
Est. primary completion date | January 1, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 16 Years |
Eligibility |
Inclusion Criteria: - Patients aged 6-16 years of age - Patients who are fit and healthy or with an ASA1 or ASA2 medical conditions - Patients with cooperation level that would allow treatment under local analgesia - Patients with a traumatised permanent incisors, canines or premolars having at least one of the following: - Necrotic or partially necrotic root canal systems. - Periapical periodontitis/abscess. - Sinus tract. - Patients with permanent incisors, canines or premolars that have incomplete root formation with open apices. Exclusion Criteria: - Patient older than 16 year of age - Patients allergic to Ciprofloxacin, Metronidazole. - Patients with medical conditions and/or receiving medications that would affect patients' body's ability to heal such as diabetic patients or ability of the patients' blood to clot such as patients with Von Willebrand's disease. - Patients with risk of developing infective endocarditis or immune compromised patients. - Patients with non traumatised non-vital permanent incisors, canines or premolars where root development already deemed to be completed. - No concurrent signs of other pathological root resorption, such as replacement root resorption, which could otherwise affect the prognosis of the tooth. - Uncooperative patients. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Leeds |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in root length | Root length from cement enamel junction to radiographic apex measured over time | Month 3, Month 9, Year 2, and year 3. | |
Primary | Change in root dentinal wall width | Root dentinal width measured radiographically at 2/3 root length over time | Month 3, Month 9, Year 2, and year 3. | |
Primary | Change in apical foramen width | Apical foramen width measured radiographically over time | Month 3, Month 9, Year 2, and year 3. | |
Primary | Change in periodontal healing | Absence of signs and symptoms of infection over time | Month 3, Month 6, Month 9, Year 2, and year 3. | |
Secondary | Change in crown Colour | Crown colour change measured using CIELAB scores | Month 3,Month 12, year 2, and year 3. |
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