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

Not Applicable

Not yet recruiting

• Conditions: Sinus Tract; Multi Visit; Bioceramic Sealer; Singler Visit; Single Cone Obturation Technique
• Interventions: Procedure: sinus tract healing in single or multi visit with single cone technique with bioceramic sealer

• Registration Number: NCT05454436
• Lead Sponsor: Majmaah University

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.

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 Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-09
• Study Start: 2022-10-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healing rate of intra oral sinus tract in multi visit by SCT with bioceramic sealer	sinus tract healing in single or multi visit with single cone technique 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.
Healing rate of intra oral sinus tract in single visit by SCT with bioceramic sealer	sinus tract healing in single or multi visit with single cone technique 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.

Primary Outcome Measures

Name	Time	Method
Healing rate of intra oral sinus tract in single visit and multi visit root canal treatment	7 days , 14 days, 30 days	To see is there sinus tract disappear after treatment

Secondary Outcome Measures

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