NCT05454436

Brief Summary

The aim of clinical trial is to see is there any difference in the outcome of healing of the intraoral sinus tract when treat in single or multi-visit root canal treatment by an endodontist.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

First Submitted

Initial submission to the registry

June 15, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

June 15, 2022

Last Update Submit

September 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Healing rate of intra oral sinus tract in single visit and multi visit root canal treatment

    To see is there sinus tract disappear after treatment

    7 days , 14 days, 30 days

Secondary Outcomes (1)

  • Healing rate of intra oral sinus tract when treat with single cone technique with bioceramic sealer

    7 days , 14 days, 30 days

Study Arms (2)

Healing rate of intra oral sinus tract in single visit by SCT with bioceramic sealer

EXPERIMENTAL

When a patient comes with intra oral sinus tract will treat in a single visit. The treatment protocol will be: cleaning and shaping by NITI file ( pro taper gold ) with Naocl 5.25%, EDTA 17% and saline then the canal will be obturate by single cone technique with bioceramic sealer.

Procedure: sinus tract healing in single or multi visit with single cone technique with bioceramic sealer

Healing rate of intra oral sinus tract in multi visit by SCT with bioceramic sealer

EXPERIMENTAL

When a patient comes with intra-oral sinus tract will treat in a multi-visit. The treatment protocol will : cleaning and shaping by NITI file ( pro taper gold ) with Naocl 5.25%, EDTA 17%, and saline then ca(oh)2 use as Intracanal medication the after disappear the sinus tract the canal will obturate by single cone technique with bioceramic sealer.

Procedure: sinus tract healing in single or multi visit with single cone technique with bioceramic sealer

Interventions

Investigators will see the healing rate between single visit and multi visit with single cone technique with bioceramic sealer .

Healing rate of intra oral sinus tract in multi visit by SCT with bioceramic sealerHealing rate of intra oral sinus tract in single visit by SCT with bioceramic sealer

Eligibility Criteria

Age6 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTo see is there any significate difference in gender
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Tooth with a sinus tract and radiographic evidence of periradicular bone destruction, Tooth with a necrotic pulp confirmed by pulp tests or with previous root canal treatment, Tooth that was restorable and had an indication for root canal treatment or retreatment, Tooth with a mobility score \<3 Absence of periodontal pockets \>4 mm deep Patients without significant systemic disease.

You may not qualify if:

  • Tooth without a sinus tract . Tooth that was not restorable Tooth with a mobility score \>3 Absence of periodontal pockets \<4 mm deep Patients with significant systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group : Group A: The treatment will be in a single visit Group B:The treatment will be in Multi visit
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Department of Restorative Dental Sciences. College of Dentistry,

Study Record Dates

First Submitted

June 15, 2022

First Posted

July 12, 2022

Study Start

October 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

September 9, 2022

Record last verified: 2022-09