Radiographic Comparison of Obturation Performed by Conventional Method and Obtura II.

Tooth Disease Clinical Trial

Official title:

Radiographic Comparison of Obturation Performed by Conventional Method and Obtura II.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711511
• Other study ID #: SOD/ERB/2022/15
• Status: Recruiting
• Phase: N/A
• Start date: August 27, 2022
• Est. completion date: March 2, 2023

Study information

• Verified date: January 2023
• Source: Pakistan Institute of Medical Sciences
• Contact: Sheejia Asif, Bds
• Phone: 03165518512
• Email: sheejiaasif344[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: March 2, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Disease
• Tooth Diseases

Intervention

Procedure:
• conventional obturation technique
cold lateral condensation ,this technique involves placing a single cone of gutta-percha (GP) with sealer in the prepared root canal and adding secondary GP cones that are compacted together with the use of a spreader. The cones stay together due to frictional grip and the presence of a sealer

Device:
• Obtura II
is a popular warm gutta-percha technique that uses a "gun" to warm and inject the gutta-percha filling into the root canal.Obtura 2 system: The gutta-percha is heated from temperature range of 160C to 200C which is then injected through the needle

Locations

Country	Name	City	State
Pakistan	Pims ,school of dentistry	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optimum extension,overextension ,under extension of obturating material	radiographically observing the extension of obturating material	immediately after the procedure
Secondary	Density	radiographically observing the voids in obturation	immediately after the procedure
Secondary	adaptation of Gutta percha	radiographically observing the gap between gp and canal wall	immediately after procedure