Clinical trial NCT05454436: The Outcome of Healing Intraoral Sinus Tract With a Single or Multi-visit With Bioceramic Sealer
Official title: The Outcome of Healing Intraoral Sinus Tract With a Single or Multi-visit With Bioceramic Sealer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Tract
Singler Visit
Multi Visit
Single Cone Obturation Technique
Bioceramic Sealer
Lead sponsor: Majmaah University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group :

Group A: The treatment will be in a single visit Group B:The treatment will be in Multi visit
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Healing rate of intra oral sinus tract in single visit and multi visit root canal treatment
timeFrame: 7 days , 14 days, 30 days
Secondary outcomes:
measure: Healing rate of intra oral sinus tract when treat with single cone technique with bioceramic sealer
timeFrame: 7 days , 14 days, 30 days
Other outcomes:
Locations:
Study officials:
References: