NCT05711511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 25, 2023

Last Update Submit

January 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • optimum extension,overextension ,under extension of obturating material

    radiographically observing the extension of obturating material

    immediately after the procedure

Secondary Outcomes (2)

  • Density

    immediately after the procedure

  • adaptation of Gutta percha

    immediately after procedure

Study Arms (2)

coventional obturation technique

EXPERIMENTAL

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.

Procedure: conventional obturation techniqueDevice: Obtura II

Obtura II

ACTIVE COMPARATOR

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.

Procedure: conventional obturation techniqueDevice: Obtura II

Interventions

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

Obtura IIcoventional obturation technique
Obtura IIDEVICE

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

Obtura IIcoventional obturation technique

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pims ,school of dentistry

Islamabad, 04403, Pakistan

RECRUITING

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • sheejia asif, Bds

    Pims

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheejia Asif, Bds

CONTACT

Aqsa Waheed, Bds

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 3, 2023

Study Start

August 27, 2022

Primary Completion

February 27, 2023

Study Completion

March 2, 2023

Last Updated

February 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations