The Outcome of Healing Intraoral Sinus Tract With a Single or Multi-visit With Bioceramic Sealer

NCT ID: NCT05454436

Last Updated: 2022-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Methods and material :

Inclusion criteria as follows:

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.

Two groups will be divided into:

Group A: 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.

Group B: 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.

Follow-up examinations were performed at 7, 14, and 30 days postoperatively.

According to the clinical, the outcome was classified as:

1. Healed: the sinus tract disappeared completely.
2. Healing: the sinus tract getting smaller and can't be traced with small gutta-percha ( we need to mention GP size)
3. failed: the sinus tract persisted more than 30 days after treatment

Conditions

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Sinus Tract Singler Visit Multi Visit Single Cone Obturation Technique Bioceramic Sealer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two group :

Group A: The treatment will be in a single visit Group B:The treatment will be in Multi visit
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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 sealer

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Majmaah University

OTHER

Sponsor Role lead

Responsible Party

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FAISAL ABDULLAH ALNASSAR

Assistant professor, Department of Restorative Dental Sciences. College of Dentistry,

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1075865046

Identifier Type: -

Identifier Source: org_study_id

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