Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03045185
Other study ID # REC 12/YH0488
Secondary ID
Status Completed
Phase N/A
First received January 31, 2017
Last updated February 6, 2017
Start date January 1, 2013
Est. completion date January 1, 2017

Study information

Verified date February 2017
Source University of Leeds
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Read more »
Read more »

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Leeds

Outcome

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.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06447519 - Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not? N/A
Not yet recruiting NCT05476419 - Apical Gap Length and Adaptation of Zirconia Post Using Intraoral and Extraoral Scan of Silicon Impression Technique N/A
Completed NCT03478241 - Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems N/A
Recruiting NCT04528979 - Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer N/A
Recruiting NCT04527705 - Outcome of Endodontic Retreatment in One or Two Visits N/A
Completed NCT05381298 - Deep Margin Elevation Vs Crown Lengthening N/A
Active, not recruiting NCT03161639 - Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth N/A
Completed NCT06226740 - Effectiveness of Different Obturation Techniques N/A
Completed NCT04310254 - Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital Teeth N/A
Completed NCT03841370 - Tooth Crown Discoloration Caused by Endodontic Treatment
Recruiting NCT03704857 - Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life N/A
Completed NCT04518371 - Clinical Performance of Milled Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year N/A
Completed NCT04638972 - Accuracy of Apex Locators in Primary Teeth
Not yet recruiting NCT04580862 - Postoperative Pain Endodontic Retreatment N/A
Completed NCT04561167 - Clinical Performance of the Indirect Resin Composite Restorations in Endodontically Treated Teeth N/A
Completed NCT04511117 - Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up N/A
Recruiting NCT05084742 - Long-term Performance and Safety of Biodentine™ in Patients Treated for Endodontic Indications
Not yet recruiting NCT04023357 - Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns. N/A
Not yet recruiting NCT03713918 - Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate N/A
Not yet recruiting NCT06450938 - No Code Artificial Intelligence to Detect Radiographic Features Associated With Unsatisfactory Endodontic Treatment N/A