ObturationNCT06260423
The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer
A study testing Experienced dentist using lateral compaction with bioceramic sealer., Unexperienced dentist using lateral compaction with bioceramic sealer. and Experienced dentist using Single cone with bioceramic sealer. in people with Obturation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obturation
- What is being tested?
- Experienced dentist using lateral compaction with bioceramic sealer., Unexperienced dentist using lateral compaction with bioceramic sealer. and Experienced dentist using Single cone with bioceramic sealer.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Apr 2025
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with symptoms of irreversible pulpitis without apical periodontitis related to the maxillary first premolar ranging from 20 to 40 years old and with separate roots were selected from patients referred to the diagnosis clinic, Faculty of dental medicine Al-Azhar University, Cairo, Boys branch.
Who cannot join
- Patients with any systemic disorders.
- Pregnancy.
- teeth with positive response to palpation test
- Non vital teeth.
- Teeth with positive response to percussion test.
- Teeth with mobility of grade II or III.
Show all 14Show fewer
- teeth with probing depth more than 3 mm.
- Teeth with abnormal morphology.
- Teeth with root curvatures more than 20 degree (according to Schneider's method).
- Teeth with internal or external root resorption.
- Teeth with vertical root fracture.
- Teeth with open apices.
- Teeth with any root canal type other than type I.
- Patients with (VDS) test with score 4 or less. 15- teeth with fused roots or single root.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar university
Cairo, 11651
Mohamed Badr, Master, 0201111777739, badrabueida@gmail.com
About this study
Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically.
Read the detailed description
The idea of using single cone obturation is not novel historically, silver points were used in conjunction with various sealers. It has the advantages of being simple, is easy to learn, quick and does not require any complicated armamentarium or devices. Furthermore, unlike lateral or vertical compaction no force is used, therefore minimizing the risks of dentinal cracks. Recently single cone obturation in combination with bioceramic sealers has been advocated as an alternative obturation technique and is rapidly gaining popularity among dentists. Some studies have demonstrated that the amount of the overall porosity of the single cone fillings is comparable to other techniques.
- Conditions
- Obturation
- Being tested
- Experienced dentist using lateral compaction with bioceramic sealer., Unexperienced dentist using lateral compaction with bioceramic sealer., Experienced dentist using Single cone with bioceramic sealer., Unexperienced dentist using Single cone with bioceramic sealer.
- Keywords
- single cone, single matched cone
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experienced dentist using lateral compaction with bioceramic sealer.Procedure or surgery
Root canal treatment using bioceramic sealers.
Unexperienced dentist using lateral compaction with bioceramic sealer.Procedure or surgery
Root canal treatment using bioceramic sealers.
Experienced dentist using Single cone with bioceramic sealer.Procedure or surgery
Root canal treatment using bioceramic sealers.
Unexperienced dentist using Single cone with bioceramic sealer.Procedure or surgery
Root canal treatment using bioceramic sealers.
| Study group | Role | What they receive |
|---|---|---|
| Experienced dentist using lateral compaction with bioceramic sealer group. | Experimental | The canals in this group obturation were obturated by an Experienced dentist using lateral compaction with bioceramic sealer. Receives: Procedure: Experienced dentist using lateral compaction with bioceramic sealer. |
| Unexperienced dentist using lateral compaction with bioceramic sealer group. | Experimental | The canals in this group obturation were obturated by an Unexperienced dentist using lateral compaction with bioceramic sealer. Receives: Procedure: Unexperienced dentist using lateral compaction with bioceramic sealer. |
| Experienced dentist using Single cone with bioceramic sealer group. | Experimental | The canals in this group obturation were obturated by an Experienced dentist using Single cone with bioceramic sealer. Receives: Procedure: Experienced dentist using Single cone with bioceramic sealer. |
| Unexperienced dentist using Single cone with bioceramic sealer group. | Experimental | The canals in this group obturation were obturated by an Unexperienced dentist using Single cone with bioceramic sealer. Receives: Procedure: Unexperienced dentist using Single cone with bioceramic sealer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment
The postoperative pain assessment was done using the modified verbal descriptor scale as follows:
None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Measured: 24 hours
Postoperative pain assessment
The postoperative pain assessment was done using the modified verbal descriptor scale as follows:
None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Measured: 48 hours
Postoperative pain assessment
The postoperative pain assessment was done using the modified verbal descriptor scale as follows:
None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Measured: 72 hours
Postoperative pain assessment
The postoperative pain assessment was done using the modified verbal descriptor scale as follows:
None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Measured: 96 hours
Postoperative pain assessment
The postoperative pain assessment was done using the modified verbal descriptor scale as follows:
None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Measured: 120 hours
Secondary outcomes (1)
The quality of obturation and the voids within the root canal filling
the quality of obturation and the voids within the root canal filling were evaluated using Modified Coll and Sadrian criteria.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObturationStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Taha Badr, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260423
- Sponsor's protocol ID
- 18/1/2024
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer
- ClinicalTrials.gov ID
- NCT06260423
- Acronym / sponsor ID
- 18/1/2024
- Conditions
- Obturation
- Keywords
- single cone, single matched cone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 15 Feb 2024 (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.
Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically.
Detailed description
The idea of using single cone obturation is not novel historically, silver points were used in conjunction with various sealers. It has the advantages of being simple, is easy to learn, quick and does not require any complicated armamentarium or devices. Furthermore, unlike lateral or vertical compaction no force is used, therefore minimizing the risks of dentinal cracks. Recently single cone obturation in combination with bioceramic sealers has been advocated as an alternative obturation technique and is rapidly gaining popularity among dentists. Some studies have demonstrated that the amount of the overall porosity of the single cone fillings is comparable to other techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experienced dentist using lateral compaction with bioceramic sealer group. | Experimental | Procedure: Experienced dentist using lateral compaction with bioceramic sealer.The canals in this group obturation were obturated by an Experienced dentist using lateral compaction with bioceramic sealer. |
| Unexperienced dentist using lateral compaction with bioceramic sealer group. | Experimental | Procedure: Unexperienced dentist using lateral compaction with bioceramic sealer.The canals in this group obturation were obturated by an Unexperienced dentist using lateral compaction with bioceramic sealer. |
| Experienced dentist using Single cone with bioceramic sealer group. | Experimental | Procedure: Experienced dentist using Single cone with bioceramic sealer.The canals in this group obturation were obturated by an Experienced dentist using Single cone with bioceramic sealer. |
| Unexperienced dentist using Single cone with bioceramic sealer group. | Experimental | Procedure: Unexperienced dentist using Single cone with bioceramic sealer.The canals in this group obturation were obturated by an Unexperienced dentist using Single cone with bioceramic sealer. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with symptoms of irreversible pulpitis without apical periodontitis related to the maxillary first premolar ranging from 20 to 40 years old and with separate roots were selected from patients referred to the diagnosis clinic, Faculty of dental medicine Al-Azhar University, Cairo, Boys branch.
Key exclusion criteria (14 listed)
- Patients with any systemic disorders.
- Pregnancy.
- teeth with positive response to palpation test
- Non vital teeth.
- Teeth with positive response to percussion test.
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 |
|---|---|---|
| Experienced dentist using lateral compaction with bioceramic sealer.Root canal treatment using bioceramic sealers. | Procedure or surgery | Experienced dentist using lateral compaction with bioceramic sealer group. |
| Unexperienced dentist using lateral compaction with bioceramic sealer.Root canal treatment using bioceramic sealers. | Procedure or surgery | Unexperienced dentist using lateral compaction with bioceramic sealer group. |
| Experienced dentist using Single cone with bioceramic sealer.Root canal treatment using bioceramic sealers. | Procedure or surgery | Experienced dentist using Single cone with bioceramic sealer group. |
| Unexperienced dentist using Single cone with bioceramic sealer.Root canal treatment using bioceramic sealers. | Procedure or surgery | Unexperienced dentist using Single cone with bioceramic sealer group. |
Primary outcome
Postoperative pain assessment
Time frame: 24 hours
The postoperative pain assessment was done using the modified verbal descriptor scale as follows: None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Postoperative pain assessment
Time frame: 48 hours
The postoperative pain assessment was done using the modified verbal descriptor scale as follows: None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Postoperative pain assessment
Time frame: 72 hours
The postoperative pain assessment was done using the modified verbal descriptor scale as follows: None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Postoperative pain assessment
Time frame: 96 hours
The postoperative pain assessment was done using the modified verbal descriptor scale as follows: None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
Postoperative pain assessment
Time frame: 120 hours
The postoperative pain assessment was done using the modified verbal descriptor scale as follows: None (Score0), Mild(Score1), Moderate (Score2), and severe (Score3).
1 secondary outcome
The quality of obturation and the voids within the root canal filling
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experienced dentist using lateral compaction with bioceramic sealer., Unexperienced dentist using lateral compaction with bioceramic sealer. and Experienced dentist using Single cone with bioceramic sealer. in people with Obturation, run by Al-Azhar University at 1 site in Egypt.
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 14 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Mohamed Badr, Master (0201111777739, badrabueida@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessment (time frame: 24 hours). The study lists 5 primary outcomes in all. 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 15 Feb 2024.