Sinus TractNCT05454436
The Outcome of Healing Intraoral Sinus Tract With a Single or Multi-visit With Bioceramic Sealer
A study testing sinus tract healing in single or multi visit with single cone technique with bioceramic sealer in people with Sinus Tract and Singler Visit, run by Majmaah University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Tract, Singler Visit, Multi Visit
- What is being tested?
- sinus tract healing in single or multi visit with single cone technique with bioceramic sealer
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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:
- Healed: the sinus tract disappeared completely.
- Healing: the sinus tract getting smaller and can't be traced with small gutta-percha ( we need to mention GP size)
- failed: the sinus tract persisted more than 30 days after treatment
- Conditions
- Sinus Tract, Singler Visit, Multi Visit, Single Cone Obturation Technique, Bioceramic Sealer
- Being tested
- sinus tract healing in single or multi visit with single cone technique with bioceramic sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus tract healing in single or multi visit with single cone technique with bioceramic sealerProcedure or surgery
Investigators will see the healing rate between single visit and multi visit with single cone technique with bioceramic sealer .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: sinus tract healing in single or multi visit with single cone technique with bioceramic sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Is this technique will effect on healing rate of sinus tract
Measured: 7 days , 14 days, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group : Group A: The treatment will be in a single visit Group B:The treatment will be in Multi visit
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FAISAL ABDULLAH ALNASSAR, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454436
- Sponsor's protocol ID
- 1075865046
- Status last verified
- Sep 2022
- First submitted
- 15 Jun 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Healing Intraoral Sinus Tract With a Single or Multi-visit With Bioceramic Sealer
- ClinicalTrials.gov ID
- NCT05454436
- Acronym / sponsor ID
- 1075865046
- Conditions
- Sinus Tract, Singler Visit, Multi Visit, Single Cone Obturation Technique, Bioceramic Sealer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Healed: the sinus tract disappeared completely.
- Healing: the sinus tract getting smaller and can't be traced with small gutta-percha ( we need to mention GP size)
- failed: the sinus tract persisted more than 30 days after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group : Group A: The treatment will be in a single visit Group B:The treatment will be in Multi visit
| Arm | Type | Receives |
|---|---|---|
| Healing rate of intra oral sinus tract in single visit by SCT with bioceramic sealer | Experimental | Procedure: sinus tract healing in single or multi visit with single cone technique with bioceramic sealerWhen 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. |
| Healing rate of intra oral sinus tract in multi visit by SCT with bioceramic sealer | Experimental | Procedure: sinus tract healing in single or multi visit with single cone technique with bioceramic sealerWhen 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. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sinus tract healing in single or multi visit with single cone technique with bioceramic sealerInvestigators will see the healing rate between single visit and multi visit with single cone technique with bioceramic sealer . | Procedure or surgery | Healing rate of intra oral sinus tract in multi visit by SCT with bioceramic sealer, Healing rate of intra oral sinus tract in single visit by SCT with bioceramic sealer |
Primary outcome
Healing rate of intra oral sinus tract in single visit and multi visit root canal treatment
Time frame: 7 days , 14 days, 30 days
To see is there sinus tract disappear after treatment
1 secondary outcome
Healing rate of intra oral sinus tract when treat with single cone technique with bioceramic sealer
Time frame: 7 days , 14 days, 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sinus tract healing in single or multi visit with single cone technique with bioceramic sealer in people with Sinus Tract and Singler Visit, run by Majmaah University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate of intra oral sinus tract in single visit and multi visit root canal treatment (time frame: 7 days , 14 days, 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.