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NCT04200638: RCT2019
Effect of Three Mechanical Systems on Removal of Endotoxins From Necrotic Teeth
NA trial testing ProTaper Next in Endodontic Disease in 30 participants. Status unknown.
13 September 2019
Quick facts
| Lead sponsor | Universidad Autonoma de Baja California |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 10 February 2019 |
| Primary completion | 13 September 2019 |
| Estimated completion | 6 December 2019 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- ProTaper Next
Conditions studied
- Endodontic Disease — all drugs for Endodontic Disease →
Sponsor
Universidad Autonoma de Baja California — full company profile →
Who can join
Adults 18 to 65, any sex, with Endodontic Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The patients will be randomly assigned into two equal groups Group : OneShape Group: ProtaperNext Endodontics procedure steps: Patient will be anesthetized by using infiltration local anesthesia or nerve block according to the tooth location in mandibular or maxillary arch respectively. All caries will be removed, then isolation using rubber dam, the crown and surrounding structures will be disinfected with 30% H2O2( hydrogen peroxide) for 30 seconds, followed by 2.5% NaOCl for the same period of time and then inactivated with 5% sodium thiosulphate. 2- For the access cavity preparation, a sterile/apyrogenic high-speed diamond bur will be used in conjunction with manual irrigation with sterile saline. Before entering the pulp chamber, the access cavity will be disinfected according to the protocol described above. 2- Root canal length will be determined, by preoperative radiograph then (S1) will be taken by introducing a sterile/apyrogenic paper point #15/ 20 (5paper points) into the full length of the canal and left there for 1 minute. Then, the sample will be placed in an apyrogenic glass and stored in -20°. Then canal length will be confirmed by apex locator. 3- Cleaning and shaping will be done using either One shape or Protaper next rotary instruments in crown down preparation technique with the use of in an endodontic motor according to the manufacturer instructions, the canals will be thoroughly irrigated using 3ml of 2.5% Sodium hypochlorite between every subsequent instrument. Lab procedures to identify microorganisms
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04200638
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ProTaper Next
Trials testing the same drug.
- NCT03791762 — Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instruments · NA · completed
- NCT03708081 — Comparative Evaluation of Different File Systems in Postoperative Pain · completed
Other recruiting trials for Endodontic Disease
Currently open trials in the same condition.
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- NCT06574152 — Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery · NA · recruiting
- NCT05935306 — Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery · NA · recruiting
- NCT06660797 — Irrigation Activating Techniques on Irrigant Penetration Depth and Microbial Reduction · NA · recruiting
Other Universidad Autonoma de Baja California trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04200638 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad Autonoma de Baja California
- Last refreshed: 16 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04200638.
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