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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sinus Tract; Singler Visit; Multi Visit; Single Cone Obturation Technique; Bioceramic Sealer
• Intervention / Treatment: Procedure: sinus tract healing in single or multi visit with single cone technique with bioceramic sealer

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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 .
Experimental: 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.	Procedure: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing rate of intra oral sinus tract when treat with single cone technique with bioceramic sealer	Is this technique will effect on healing rate of sinus tract	7 days , 14 days, 30 days

Collaborators and Investigators

• Sponsor: Majmaah University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1075865046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No