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

Primary Purpose

Tooth Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional obturation technique
Obtura II
Sponsored by
Pakistan Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pims ,school of dentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

coventional obturation technique

Obtura II

Arm Description

In conventional method, paper point will be used to coat the walls of the canal with sealer, Standardized Protaper F-3 master gutta-percha cone will slid to the working length and ISO No.25 finger spreader was applied under vertical loading.The first accessory cone will slid promptly to proper length with a light coating of sealer. Compaction and accessory cone insertion will be continued;each spreader insertion will be seen to be slightly less deep than former, as mirrored by shorter and shorter accessory cone insertion. Condensation continued until the spreader reached 2-3 mm into the canal. Heat will be applied with to the root filling at or below canal orifice level, and the filling will then compacted apically with the help of a cold plugger.

The Obtura II system will be prepared ,sealer will be applied to canal wall . A 23G needle is selected and a stopper will place at 4-6 mm of the WL. The control unit of Obtura II will be on, and the display showed the required temperature of 185°C. The gun will be loaded with a fresh pellet of gutta- percha and plunger will be pushed forward.The needle will be then positioned in the canal so that it reached 3 to 5 mm of the apical preparation. 3-4 mm of the gutta-percha was passively injected without any apical pressure and will be compacted gently with a #11 endodontic plugger. Thus, the apical plug will be created in this manner. A segmental technique will be used in which 3 to 4 mm of gutta-percha will be sequentially injected and compacted. Increments will be added until gutta-percha reached top orifice level, and then compaction will be done with a cold plugger. Excess gutta-percha was severed at or below the orifice level.

Outcomes

Primary Outcome Measures

optimum extension,overextension ,under extension of obturating material
radiographically observing the extension of obturating material

Secondary Outcome Measures

Density
radiographically observing the voids in obturation
adaptation of Gutta percha
radiographically observing the gap between gp and canal wall

Full Information

First Posted
January 25, 2023
Last Updated
January 25, 2023
Sponsor
Pakistan Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05711511
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2022 (Actual)
Primary Completion Date
February 27, 2023 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
coventional obturation technique
Arm Type
Experimental
Arm Description
In conventional method, paper point will be used to coat the walls of the canal with sealer, Standardized Protaper F-3 master gutta-percha cone will slid to the working length and ISO No.25 finger spreader was applied under vertical loading.The first accessory cone will slid promptly to proper length with a light coating of sealer. Compaction and accessory cone insertion will be continued;each spreader insertion will be seen to be slightly less deep than former, as mirrored by shorter and shorter accessory cone insertion. Condensation continued until the spreader reached 2-3 mm into the canal. Heat will be applied with to the root filling at or below canal orifice level, and the filling will then compacted apically with the help of a cold plugger.
Arm Title
Obtura II
Arm Type
Active Comparator
Arm Description
The Obtura II system will be prepared ,sealer will be applied to canal wall . A 23G needle is selected and a stopper will place at 4-6 mm of the WL. The control unit of Obtura II will be on, and the display showed the required temperature of 185°C. The gun will be loaded with a fresh pellet of gutta- percha and plunger will be pushed forward.The needle will be then positioned in the canal so that it reached 3 to 5 mm of the apical preparation. 3-4 mm of the gutta-percha was passively injected without any apical pressure and will be compacted gently with a #11 endodontic plugger. Thus, the apical plug will be created in this manner. A segmental technique will be used in which 3 to 4 mm of gutta-percha will be sequentially injected and compacted. Increments will be added until gutta-percha reached top orifice level, and then compaction will be done with a cold plugger. Excess gutta-percha was severed at or below the orifice level.
Intervention Type
Procedure
Intervention Name(s)
conventional obturation technique
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Obtura II
Intervention Description
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
Primary Outcome Measure Information:
Title
optimum extension,overextension ,under extension of obturating material
Description
radiographically observing the extension of obturating material
Time Frame
immediately after the procedure
Secondary Outcome Measure Information:
Title
Density
Description
radiographically observing the voids in obturation
Time Frame
immediately after the procedure
Title
adaptation of Gutta percha
Description
radiographically observing the gap between gp and canal wall
Time Frame
immediately after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheejia Asif, Bds
Phone
03165518512
Email
sheejiaasif344@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aqsa Waheed, Bds
Phone
03063422518
Email
q.aqsa@rocketmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sheejia asif, Bds
Organizational Affiliation
Pims
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pims ,school of dentistry
City
Islamabad
ZIP/Postal Code
04403
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheejia Asif, BDS
Phone
03165518512
Email
sheejiaasif@gmail.com
First Name & Middle Initial & Last Name & Degree
Aqsa waheed, BDS
Phone
03063422518
Email
q.aqsa@rocketmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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