Regenerative Endodontic Treatment of Traumatised Teeth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03045185|
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tooth Injuries Endodontically Treated Teeth||Procedure: RET using Ciprofloxacin 100mg, and Metronidazole 100mg.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective interventional uncontrolled trial|
|Masking:||None (Open Label)|
|Masking Description:||Single group so no masking|
|Official Title:||A Prospective Clinical Study of Regenerative Endodontic Treatment of Traumatised Non-vital Immature Teeth Using Bi-antibiotic Paste|
|Actual Study Start Date :||January 1, 2013|
|Actual Primary Completion Date :||January 1, 2015|
|Actual Study Completion Date :||January 1, 2017|
Experimental: Treatment Group
RET using Ciprofloxacin 100mg, and Metronidazole 100mg.
Procedure: RET using Ciprofloxacin 100mg, and Metronidazole 100mg.
First Treatment Visit: Tooth isolation, access, pulp extirpation and root canal irrigation with 0.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the Bi antibiotic paste (mixture of Bi antibiotic paste (Ciprofloxacin 100mg and Metronidazole 100mg with sterile water). Sealing tooth access with glass ionomer cement.
Second Treatment Visit: Tooth analgesia using plain local analgesics, isolatation and re-access as described above. Irrigation of root canal system using normal saline followed by paper point dying. Initiation of bleeding through insertion of a sterile 23-gauge needle with a length of 2 mm beyond the working length into the periapical tissues. Access sealed using Portland cement, followed by glass ionomer and then composite resin.
- Change in root length [ Time Frame: Month 3, Month 9, Year 2, and year 3. ]Root length from cement enamel junction to radiographic apex measured over time
- Change in root dentinal wall width [ Time Frame: Month 3, Month 9, Year 2, and year 3. ]Root dentinal width measured radiographically at 2/3 root length over time
- Change in apical foramen width [ Time Frame: Month 3, Month 9, Year 2, and year 3. ]Apical foramen width measured radiographically over time
- Change in periodontal healing [ Time Frame: Month 3, Month 6, Month 9, Year 2, and year 3. ]Absence of signs and symptoms of infection over time
- Change in crown Colour [ Time Frame: Month 3,Month 12, year 2, and year 3. ]Crown colour change measured using CIELAB scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045185
|Principal Investigator:||Hani Nazzal, BDS, PhD||University of Leeds, School of Dentistry, Paediatric Dentistry Department|