Clinical trial NCT05711511: Radiographic Comparison of Obturation Performed by Conventional Method and Obtura II.
Official title: Radiographic Comparison of Obturation Performed by Conventional Method and Obtura II.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Disease
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2023-02-03
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Root canal therapy plays an importanmt role in dental health care.An importanat parameter necessary to achieve a proper endodontic treatment is quality of root canal filling.This study compare the radiographic quality of obturation with cold lateral condensation and thermoplasticiszed gutta percha technique and obtura II system.

Detailed description: The aim of this study is to assess and compare the radiogrphic quality of obturation with thermoplasticized injectable gutta percha technique obtura II system and cold lateral compaction technique in permanent teeth.For this study selected patients will be divided into two groups in a manner that the odd numbers will be alotted to Group A and Group B .Local anesthesia at 2% lidocaineHCl with 1:100000 epinephrine as buccal infiltration in upper teeth and inferior alveolar nerve block in the lower teeth. Access cavity preparation will be done. Canals will be located and negotiated with a DG-16 endodontic explorer . Initial filing will be done from Number 8 to 10 K- files (ISO standardized 0.02 taper) under 5.25% sodium hypochlorite) irrigation and Ethylenediamine Tetra-Acetic Acid as chelating agents.. Working Length will be confirmed with Electronic Apex Locator , and then with working length radiograph will be taken. Rotary preparation will be done with Protaper using S1, S2, F1, F2, F3 files. Master gutta-percha radiograph will be taken at the commencement of the first visit with Protaper F3 gutta-percha point placed in the canals. Intervention will be provided to both groups by the principal investigator. On the second visit, both the canals will be dried with F-3 paper points.Root canal fillings will be then performed using cold lateral condensation in Group A, and thermoplasticized injected gutta-percha in Group B.

Postoperative periapical radiographs will be obtained immediately after the obturation. These radiographs will be examined under illumination in a darkened room at ×2 magnification to assess for voids and termination of obturation. Our study will be based on the radiographic assessment of the buccolingual view of the canals, as it will be the only possible view to visualize on the radiograph in a clinical setting for assessing the quality of endodontic treatment.

Root canal fillings will be assessed

* Presence or absence of voids.
* Acceptable/flush: Root canal filling is within the root canal system and within 2 mm of radiographic apex.
* Under-filled: Root canal filling is \>2 mm short of radiographic apex.
* Over-filled: Root canal filling is extruded beyond the radiographic apex

Eligibility criteria: Inclusion Criteria:

* Single rooted teeth in which endodontic treatment was clinically indicated.
* Single rooted teeeth in which root canal treatment was recommended for elective reasons.

Exclusion Criteria:

* • Teeth with severely curved roots.

  * Sclerosed canals on periapical radiographs.
  * Periodontally compromised teeth.
  * Endodontic retreatment cases.
  * Teeth with apical resorption.
  * Teeth not salvageable by conventional root canal treatment.

Primary outcomes:
measure: optimum extension,overextension ,under extension of obturating material
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Density
timeFrame: immediately after the procedure
measure: adaptation of Gutta percha
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pims ,school of dentistry
Study officials:
affiliation: Pims
name: sheejia asif, Bds
role: PRINCIPAL_INVESTIGATOR
References: