Postoperative PainNCT06146894
The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment
A study testing Single obturation technique (Bioceramic Sealer), lateral condensation technique (Bioceramic Sealer) and Warm Vertical condensation technique (Bioceramic Sealer) in people with Postoperative Pain, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The goal of this prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (American Society of Anesthesiology class I or II) and require nonsurgical root… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Single obturation technique (Bioceramic Sealer), lateral condensation technique (Bioceramic Sealer) and Warm Vertical condensation technique (Bioceramic Sealer)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 28 Jun 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-60 years who presented no systemic disease (American Society of Anesthesiology class I or II) and required nonsurgical root canal treatment.
- Diagnosis of asymptomatic irreversible pulpitis in a molar tooth with 3 independent root canals.
Who cannot join
- Presence of immature root apexes, root fracture, or periodontal disease
- Use of any analgesic, anti- inflammatory, or antibiotics before the treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
kafrelsheikh University
Kafr ash Shaykh, Kafr El-Shaikh, 33511
hisham abada, phd
About this study
Official title: The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment: A Prospective Clinical Randomized Study
The goal of this prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (American Society of Anesthesiology class I or II) and require nonsurgical root canal treatment The main question it aims to answer which obturation technique used with bioceramic sealer cause less postobturation pain in single-visit root canal treatment in comparison to AH plus sealer used with lateral condensation or warm vertical compaction.
Participants will receive single visit root canal treatment using bioceramic sealer with different obturation techniques Group 1: Single cone technique Group 2: lateral condensation technique Group 3: Vertical compaction technique to see effect of different obturation technique on postobturation pain in single-visit root canal treatment.
- Conditions
- Postoperative Pain
- Being tested
- Single obturation technique (Bioceramic Sealer), lateral condensation technique (Bioceramic Sealer), Warm Vertical condensation technique (Bioceramic Sealer), lateral condensation technique (AH Plus Sealer), Warm Vertical condensation technique (AH plus Sealer)
- Keywords
- Postoperative Pain, Bioceramic sealer, Obturation
- Medical subject headings
- Pain, Postoperative, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single obturation technique (Bioceramic Sealer)Procedure or surgery
Root canal will be obturated using single cone technique using Bioceramic Sealer
lateral condensation technique (Bioceramic Sealer)Procedure or surgery
Root canal will be obturated using lateral condensation technique using Bioceramic Sealer
Warm Vertical condensation technique (Bioceramic Sealer)Procedure or surgery
Root canal will be obturated using vertical condensation technique using Bioceramic Sealer
lateral condensation technique (AH Plus Sealer)Procedure or surgery
Root canal will be obturated using lateral condensation technique using AH plus Sealer
Warm Vertical condensation technique (AH plus Sealer)Procedure or surgery
Root canal will be obturated using vertical condensation technique using AH plus Sealer
| Study group | Role | What they receive |
|---|---|---|
| Single cone technique (Bioceramic Sealer) | Experimental | Not described Receives: Procedure: Single obturation technique (Bioceramic Sealer) |
| lateral condensation technique (Bioceramic Sealer) | Experimental | Not described Receives: Procedure: lateral condensation technique (Bioceramic Sealer) |
| Warm Vertical condensation technique (Bioceramic Sealer) | Experimental | Not described Receives: Procedure: Warm Vertical condensation technique (Bioceramic Sealer) |
| lateral condensation technique (AH plus Sealer) | Experimental | Not described Receives: Procedure: lateral condensation technique (AH Plus Sealer) |
| Warm Vertical condensation technique (AH plus Sealer) | Experimental | Not described Receives: Procedure: Warm Vertical condensation technique (AH plus Sealer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postobturation pain
Presence of post-obturation pain will accessed by visual analog scale (VAS) scale (0-10), where 0 showed no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, and 10 worst possible pain.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Dec 2023
- Primary completion10 Jun 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mahmoud Hamdy Abada, Kafrelsheikh University
- Investigators
- Hisham Abada, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146894
- Sponsor's protocol ID
- HA2427
- Status last verified
- Jun 2024
- First submitted
- 17 Nov 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment: A Prospective Clinical Randomized Study
- ClinicalTrials.gov ID
- NCT06146894
- Acronym / sponsor ID
- HA2427
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Bioceramic sealer, Obturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 27 Nov 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 prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (American Society of Anesthesiology class I or II) and require nonsurgical root canal treatment The main question it aims to answer which obturation technique used with bioceramic sealer cause less postobturation pain in single-visit root canal treatment in comparison to AH plus sealer used with lateral condensation or warm vertical compaction.
Participants will receive single visit root canal treatment using bioceramic sealer with different obturation techniques Group 1: Single cone technique Group 2: lateral condensation technique Group 3: Vertical compaction technique to see effect of different obturation technique on postobturation pain in single-visit root canal treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single cone technique (Bioceramic Sealer) | Experimental | Procedure: Single obturation technique (Bioceramic Sealer) |
| lateral condensation technique (Bioceramic Sealer) | Experimental | Procedure: lateral condensation technique (Bioceramic Sealer) |
| Warm Vertical condensation technique (Bioceramic Sealer) | Experimental | Procedure: Warm Vertical condensation technique (Bioceramic Sealer) |
| lateral condensation technique (AH plus Sealer) | Experimental | Procedure: lateral condensation technique (AH Plus Sealer) |
| Warm Vertical condensation technique (AH plus Sealer) | Experimental | Procedure: Warm Vertical condensation technique (AH plus Sealer) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 18-60 years who presented no systemic disease (American Society of Anesthesiology class I or II) and required nonsurgical root canal treatment.
- Diagnosis of asymptomatic irreversible pulpitis in a molar tooth with 3 independent root canals.
Key exclusion criteria (2 listed)
- Presence of immature root apexes, root fracture, or periodontal disease
- Use of any analgesic, anti- inflammatory, or antibiotics before the treatment.
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 |
|---|---|---|
| Single obturation technique (Bioceramic Sealer)Root canal will be obturated using single cone technique using Bioceramic Sealer | Procedure or surgery | Single cone technique (Bioceramic Sealer) |
| lateral condensation technique (Bioceramic Sealer)Root canal will be obturated using lateral condensation technique using Bioceramic Sealer | Procedure or surgery | lateral condensation technique (Bioceramic Sealer) |
| Warm Vertical condensation technique (Bioceramic Sealer)Root canal will be obturated using vertical condensation technique using Bioceramic Sealer | Procedure or surgery | Warm Vertical condensation technique (Bioceramic Sealer) |
| lateral condensation technique (AH Plus Sealer)Root canal will be obturated using lateral condensation technique using AH plus Sealer | Procedure or surgery | lateral condensation technique (AH plus Sealer) |
| Warm Vertical condensation technique (AH plus Sealer)Root canal will be obturated using vertical condensation technique using AH plus Sealer | Procedure or surgery | Warm Vertical condensation technique (AH plus Sealer) |
Primary outcome
postobturation pain
Time frame: 30 days
Presence of post-obturation pain will accessed by visual analog scale (VAS) scale (0-10), where 0 showed no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, and 10 worst possible pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Related InfoLink provided by the sponsor.
- 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.
Hisham Abada, PhD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single obturation technique (Bioceramic Sealer), lateral condensation technique (Bioceramic Sealer) and Warm Vertical condensation technique (Bioceramic Sealer) in people with Postoperative Pain, run by Kafrelsheikh 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 2 inclusion and 2 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 6 Jun 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 Hisham Abada, PhD (01003772427 ext. 002, Hisham.dentist@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postobturation pain (time frame: 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 6 Jun 2024.