ObturationNCT05808062
The Effect of Canal Dryness on the Quality of Obturation
A study testing Root canal obturation in people with Obturation, run by British University In Egypt at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate root canal obturation quality. The questions to answer are what is the best protocol for canal dryness before obturation ? Is compaction necessary ? Volunteer participants will perform root canal treatment in teeth planned for extraction due to orthodontic reasons Read more about this study
- Who is it for?
- Ages 23 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obturation
- What is being tested?
- Root canal obturation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 31 Dec 2022
- 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 23 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males and females (Category: American Society of Anesthesiologists class 1)
- aged 23-25 years
- presenting with sound maxillary premolars (non-carious and not previously restored)
- a radiographically visible root canal outline
Who cannot join
- dental students of any level were not eligible to avoid including vulnerability factors.
- pregnant volunteers
- volunteers with complicating systemic disease (ASA 3-6)
- poor oral hygiene
- periodontal disease (probing depth >3 mm) related to the tooth
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, The British University in Egypt
Cairo, El-Sherouk, 11837
About this study
Official title: The Effect of Different Canal Dryness Protocols on the Quality of Matched Single Cone Obturation: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate root canal obturation quality. The questions to answer are
- what is the best protocol for canal dryness before obturation ?
- Is compaction necessary ? Volunteer participants will perform root canal treatment in teeth planned for extraction due to orthodontic reasons
- Conditions
- Obturation
- Being tested
- Root canal obturation
- 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.
Root canal obturationProcedure or surgery
Root canal dryness
| Study group | Role | What they receive |
|---|---|---|
| Total dryness | Active comparator | matching paper points are used till they come out completely dry Receives: Procedure: Root canal obturation |
| Partial dryness | Active comparator | a single matching cone is inserted in the canal for 3 seconds only. Receives: Procedure: Root canal obturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
obturation quality
percentage of voids within the filling by micro CT analysis
Measured: after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObturationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shehabeldin saber, British University In Egypt
- Investigators
- Shehabeldin Saber, phD, Principal investigator, Faculty of Dentistry, The British University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808062
- Sponsor's protocol ID
- 21-038
- Status last verified
- Aug 2023
- First submitted
- 29 Mar 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.
PubMed 32183124Nawar NN, Elashiry MM, El Banna A, Saber SM, Schafer E. Ex-vivo evaluation of clinically-set hydraulic sealers used with different canal dryness protocols and obturation techniques: a randomized clinical trial. Clin Oral Investig. 2024 Oct 27;28(11):612. doi: 10.1007/s00784-024-06006-5.
PubMed 39463194
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Canal Dryness Protocols on the Quality of Matched Single Cone Obturation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05808062
- Acronym / sponsor ID
- 21-038
- Conditions
- Obturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Apr 2023 (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 goal of this clinical trial is to evaluate root canal obturation quality. The questions to answer are
- what is the best protocol for canal dryness before obturation ?
- Is compaction necessary ? Volunteer participants will perform root canal treatment in teeth planned for extraction due to orthodontic reasons
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total dryness | Active comparator | Procedure: Root canal obturationmatching paper points are used till they come out completely dry |
| Partial dryness | Active comparator | Procedure: Root canal obturationa single matching cone is inserted in the canal for 3 seconds only. |
Who may qualify
- Ages
- 23 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy males and females (Category: American Society of Anesthesiologists class 1)
- aged 23-25 years
- presenting with sound maxillary premolars (non-carious and not previously restored)
- a radiographically visible root canal outline
Key exclusion criteria (5 listed)
- dental students of any level were not eligible to avoid including vulnerability factors.
- pregnant volunteers
- volunteers with complicating systemic disease (ASA 3-6)
- poor oral hygiene
- periodontal disease (probing depth >3 mm) related to the tooth
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 |
|---|---|---|
| Root canal obturationRoot canal dryness | Procedure or surgery | Partial dryness, Total dryness |
Primary outcome
obturation quality
Time frame: after 30 days
percentage of voids within the filling by micro CT analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Results publication: PubMed 32183124Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.
- Derived from this study: PubMed 39463194Nawar NN, Elashiry MM, El Banna A, Saber SM, Schafer E. Ex-vivo evaluation of clinically-set hydraulic sealers used with different canal dryness protocols and obturation techniques: a randomized clinical trial. Clin Oral Investig. 2024 Oct 27;28(11):612. doi: 10.1007/s00784-024-06006-5.
- Individual participant dataSharing planned: Yes
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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.
Shehabeldin Saber, phD principal investigator
Faculty of Dentistry, The British University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal obturation in people with Obturation, run by British University In Egypt 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 3 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
obturation quality (time frame: after 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808062, which also lists 2 linked publications.
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 3 Aug 2023.