Periapical LesionsNCT06400030
A Comparison Between Two Types of Sealers in the Healing of Periapical Lesions
A study testing Root canal treatment with AH Plus sealer and Root canal treatment with BioCeramic sealer in people with Periapical Lesions, run by Damascus University at 1 site in Syria.
Trial summary
This clinical study will evaluate the effect of BioCeramic sealer with single cone compared with the control group treated with AH Plus with lateral condensation in root canal obturation on the healing of periapical lesions. The study sample will consist of 41 patients with 65 teeth with clear periapical lesions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Lesions
- What is being tested?
- Root canal treatment with AH Plus sealer and Root canal treatment with BioCeramic sealer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSyria
- Study dates
- 22 Jun 2020to 15 Apr 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- One maxillary anterior tooth with a clear periapical lesion at least.
- Normal anatomic features and straight or slightly curved roots.
- The treated teeth must have complete roots and a closed apex.
- The ability to isolate the teeth with a rubber dam and restore them.
- Good oral hygiene.
- Good systemic health.
Who cannot join
- Root caries.
- Root fractures or resorption.
- Signs of occlusal trauma on the treated tooth.
- Internal or external resorption.
- Active periodontal disease.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of BioCeramic Sealer With Single Cone Technique on the Healing of Periapical Lesions: A Randomized Controlled Trial
This clinical study will evaluate the effect of BioCeramic sealer with single cone compared with the control group treated with AH Plus with lateral condensation in root canal obturation on the healing of periapical lesions.
The study sample will consist of 41 patients with 65 teeth with clear periapical lesions.
Root canal obturation will be applied for all patients. BioCeramic sealer will be applied for the experimental group only.
The changes of the dimensions of the periapical lesion will be assessed using CBCT radiographs; pre- and post- treatment changes for each group will be evaluated individually.
Read the detailed description
Periapical lesions is considered as the most common symptoms associated with infected root canals.
Recently, the BioCeramic sealer has been considered one of the most common endodontic sealer that possess antibacterial properties, so it can have an effective role in the healing of periapical lesions, as well as its ability to prevent periapical leakage due to its attachment to the dentinal walls and gutta-percha cones.
This study will evaluate the effect of BioCeramic sealer on the healing of periapical lesions and the changes of the dimensions of the lesions.
Root canal obturation with gutta-percha cones will be applied in the two groups: The control group will receive the AH Plus with lateral condensation technique, and the experimental group will receive BioCeramic sealer with single cone technique.
CBCT radiographs will be gotten before and after one year of the treatment to evaluate the periapical lesion dimensions changes.
- Conditions
- Periapical Lesions
- Being tested
- Root canal treatment with AH Plus sealer, Root canal treatment with BioCeramic sealer
- Keywords
- Single Cone Technique, Lateral Condensation, BioCeramic-based Sealer, AH Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment with AH Plus sealerProcedure or surgery
- AH Plus sealer Group: the base and accelerator of AH Plus Sealer was mixed, then the walls of the canal were coated with the AH Plus sealer using K-File, then lateral condensation was performed through a number of gutta-percha cones.
Root canal treatment with BioCeramic sealerProcedure or surgery
- BioCeramic Sealer Group: the canals in this group were filled using BioCeramic-based sealer and a single gutta-percha cone, and gently insert it into the root canal to the preselected working length without applying pressure.
| Study group | Role | What they receive |
|---|---|---|
| AH Plus sealer Group (Control Group) | Other | in this group, root canal system was filled with AH Plus sealer in conjunction with lateral condensation. Receives: Procedure: Root canal treatment with AH Plus sealer |
| BioCeramic Sealer Group (Experimental Group | Experimental | in this group, root canal system was filled with BioCeramic-based sealer in conjunction with single gutta-percha cone. Receives: Procedure: Root canal treatment with BioCeramic sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the periapical lesion diameter
This diameter of the periapical lesions is going to be measured on a CBCT image.
Initially, the sections of the periapical lesions will be evaluated in the three planes (sagittal, coronal, and axial). The section that contains the largest area of the lesion in each studied plane, will be used for measurement.
- If the shape of periapical lesion is circular, the periapical diameter would be taken (at this plane) relying on the scale in the program accompanying the radiograph (CBCT).
- If the shape of periapical lesion is not circular, the largest and smallest diameter of the lesion will be taken (at this plane) depending on the scale in the program accompanying the CBCT image, then the mean diameter will be calculated by collecting the previous two diameter and dividing them by 2.
Ultimately, the three diameters of the lesion (taken at the three planes) are collected and the total is divided into 3 to obtain the mean diameter of the lesion.
Measured: before and after one year of the treatment (root canal obturation)
Secondary outcomes (1)
Change in the presence of edema
The detection of the edema will be performed using clinical examination (palpating the buccal tissues of the treated tooth).
Time Frame: before, after six months, and after one year of the treatment (root canal obturation)
Measured: before, after six months, and one year of the treatment (root canal obturation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start22 Jun 2020
- Primary completion1 Mar 2022
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Periapical LesionsStudies 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400030
- Sponsor's protocol ID
- UDDS-Endo-1-2024
- Status last verified
- May 2024
- First submitted
- 20 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32183124Martins JFB, Scheeren B, van der Waal SV. The Effect of Unintentional AH-Plus Sealer Extrusion on Resolution of Apical Periodontitis After Root Canal Treatment and Retreatment-A Retrospective Case-control Study. J Endod. 2023 Oct;49(10):1262-1268. doi: 10.1016/j.joen.2023.07.021. Epub 2023 Jul 28.
PubMed 37516239Chybowski EA, Glickman GN, Patel Y, Fleury A, Solomon E, He J. Clinical Outcome of Non-Surgical Root Canal Treatment Using a Single-cone Technique with Endosequence Bioceramic Sealer: A Retrospective Analysis. J Endod. 2018 Jun;44(6):941-945. doi: 10.1016/j.joen.2018.02.019. Epub 2018 Mar 29.
PubMed 29606401Khandelwal A, Janani K, Teja K, Jose J, Battineni G, Riccitiello F, Valletta A, Palanivelu A, Spagnuolo G. Periapical Healing following Root Canal Treatment Using Different Endodontic Sealers: A Systematic Review. Biomed Res Int. 2022 Jul 8;2022:3569281. doi: 10.1155/2022/3569281. eCollection 2022.
PubMed 35845966Del Fabbro M, Corbella S, Sequeira-Byron P, Tsesis I, Rosen E, Lolato A, Taschieri S. Endodontic procedures for retreatment of periapical lesions. Cochrane Database Syst Rev. 2016 Oct 19;10(10):CD005511. doi: 10.1002/14651858.CD005511.pub3.
PubMed 27759881
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of BioCeramic Sealer With Single Cone Technique on the Healing of Periapical Lesions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06400030
- Acronym / sponsor ID
- UDDS-Endo-1-2024
- Conditions
- Periapical Lesions
- Keywords
- Single Cone Technique, Lateral Condensation, BioCeramic-based Sealer, AH Plus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 6 May 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.
This clinical study will evaluate the effect of BioCeramic sealer with single cone compared with the control group treated with AH Plus with lateral condensation in root canal obturation on the healing of periapical lesions.
The study sample will consist of 41 patients with 65 teeth with clear periapical lesions.
Root canal obturation will be applied for all patients. BioCeramic sealer will be applied for the experimental group only.
The changes of the dimensions of the periapical lesion will be assessed using CBCT radiographs; pre- and post- treatment changes for each group will be evaluated individually.
Detailed description
Periapical lesions is considered as the most common symptoms associated with infected root canals.
Recently, the BioCeramic sealer has been considered one of the most common endodontic sealer that possess antibacterial properties, so it can have an effective role in the healing of periapical lesions, as well as its ability to prevent periapical leakage due to its attachment to the dentinal walls and gutta-percha cones.
This study will evaluate the effect of BioCeramic sealer on the healing of periapical lesions and the changes of the dimensions of the lesions.
Root canal obturation with gutta-percha cones will be applied in the two groups: The control group will receive the AH Plus with lateral condensation technique, and the experimental group will receive BioCeramic sealer with single cone technique.
CBCT radiographs will be gotten before and after one year of the treatment to evaluate the periapical lesion dimensions changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AH Plus sealer Group (Control Group) | Other | Procedure: Root canal treatment with AH Plus sealerin this group, root canal system was filled with AH Plus sealer in conjunction with lateral condensation. |
| BioCeramic Sealer Group (Experimental Group | Experimental | Procedure: Root canal treatment with BioCeramic sealerin this group, root canal system was filled with BioCeramic-based sealer in conjunction with single gutta-percha cone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- One maxillary anterior tooth with a clear periapical lesion at least.
- Normal anatomic features and straight or slightly curved roots.
- The treated teeth must have complete roots and a closed apex.
- The ability to isolate the teeth with a rubber dam and restore them.
- Good oral hygiene.
Key exclusion criteria (6 listed)
- Root caries.
- Root fractures or resorption.
- Signs of occlusal trauma on the treated tooth.
- Internal or external resorption.
- Active periodontal 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 |
|---|---|---|
| Root canal treatment with AH Plus sealer- AH Plus sealer Group: the base and accelerator of AH Plus Sealer was mixed, then the walls of the canal were coated with the AH Plus sealer using K-File, then lateral condensation was performed through a number of gutta-percha cones. | Procedure or surgery | AH Plus sealer Group (Control Group) |
| Root canal treatment with BioCeramic sealer- BioCeramic Sealer Group: the canals in this group were filled using BioCeramic-based sealer and a single gutta-percha cone, and gently insert it into the root canal to the preselected working length without applying pressure. | Procedure or surgery | BioCeramic Sealer Group (Experimental Group |
Primary outcome
Change in the periapical lesion diameter
Time frame: before and after one year of the treatment (root canal obturation)
This diameter of the periapical lesions is going to be measured on a CBCT image. Initially, the sections of the periapical lesions will be evaluated in the three planes (sagittal, coronal, and axial). The section that contains the largest area of the lesion in each studied plane, will be used for measurement. * If the shape of periapical lesion is circular, the periapical diameter would be taken (at this plane) relying on the scale in the program accompanying the radiograph (CBCT). * If the shape of periapical lesion is not circular, the largest and smallest diameter of the lesion will be taken (at this plane) depending on the scale in the program accompanying the CBCT image, then the mean diameter will be calculated by collecting the previous two diameter and dividing them by 2. Ultimately, the three diameters of the lesion (taken at the three planes) are collected and the total is divided into 3 to obtain the mean diameter of the lesion.
1 secondary outcome
Change in the presence of edema
Time frame: before, after six months, and one year of the treatment (root canal obturation)
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 6 May 2024.
- Background: 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.
- Background: PubMed 37516239Martins JFB, Scheeren B, van der Waal SV. The Effect of Unintentional AH-Plus Sealer Extrusion on Resolution of Apical Periodontitis After Root Canal Treatment and Retreatment-A Retrospective Case-control Study. J Endod. 2023 Oct;49(10):1262-1268. doi: 10.1016/j.joen.2023.07.021. Epub 2023 Jul 28.
- Background: PubMed 29606401Chybowski EA, Glickman GN, Patel Y, Fleury A, Solomon E, He J. Clinical Outcome of Non-Surgical Root Canal Treatment Using a Single-cone Technique with Endosequence Bioceramic Sealer: A Retrospective Analysis. J Endod. 2018 Jun;44(6):941-945. doi: 10.1016/j.joen.2018.02.019. Epub 2018 Mar 29.
- Background: PubMed 35845966Khandelwal A, Janani K, Teja K, Jose J, Battineni G, Riccitiello F, Valletta A, Palanivelu A, Spagnuolo G. Periapical Healing following Root Canal Treatment Using Different Endodontic Sealers: A Systematic Review. Biomed Res Int. 2022 Jul 8;2022:3569281. doi: 10.1155/2022/3569281. eCollection 2022.
- Background: PubMed 27759881Del Fabbro M, Corbella S, Sequeira-Byron P, Tsesis I, Rosen E, Lolato A, Taschieri S. Endodontic procedures for retreatment of periapical lesions. Cochrane Database Syst Rev. 2016 Oct 19;10(10):CD005511. doi: 10.1002/14651858.CD005511.pub3.
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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.
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 treatment with AH Plus sealer and Root canal treatment with BioCeramic sealer in people with Periapical Lesions, run by Damascus University at 1 site in Syria.
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 6 inclusion and 6 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 6 May 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 Syria. 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?
Change in the periapical lesion diameter (time frame: before and after one year of the treatment (root canal obturation)). 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 NCT06400030, which also lists 5 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 6 May 2024.