Evaluation of two dental materials in regenerative treatment of non-vital teeth with incomplete root development
| ISRCTN | ISRCTN69846868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69846868 |
| Secondary identifying numbers | 848/SM |
- Submission date
- 07/01/2024
- Registration date
- 16/01/2024
- Last edited
- 16/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Traumatic injuries in anterior teeth commonly occur among young children. These injuries may lead to loss of tooth vitality and inflammation of the surrounding tissues, which requires endodontic treatment. Loss of vitality leads to the growth of the root stopping, resulting in the formation of a weak root with thin and short walls that are more prone to fracture. These teeth are called "immature teeth". Several methods have been described to treat these teeth and regenerative endodontics treatment has gained great interest recently because it focuses on restoring damaged structures and thus promoting root development and strengthening the walls. The main goal of regenerative treatment is to keep the pulp space free of bacteria and prevent the recurrence of infection. Bacteria from the mouth may penetrate the pulp space if the coronal seal is not adequate, leading to the recurrence of infection, which is one of the main reasons for treatment failure. This study aims to evaluate two bioceramic types of cement clinically and radiographically as coronal sealing materials in the regenerative treatment of non-vital immature teeth with apical periodontitis.
Who can participate?
Patients aged 9 to 25 years old with non-vital permanent anterior teeth with open apex and apical periodontitis
What does the study involve?
Participants were randomly divided into two groups based on the used coronal sealing material. Well Root PT (Vericom, Gangwon-Do, Korea) was applied in the first group, and MTA Biorep (Itena Clinical, Paris, France) in the second group. All patients in both groups were treated with the same protocol except for the application of the coronal plug material. The clinical and radiographic variables were registered at baseline and at 12 months after treatment. The clinical variables were pain on biting or percussion, soft tissue swelling, sinus tract, mobility, and response to pulp sensitivity test. The radiographic variables were changes in root length, root thickness, and healing of the periapical lesions.
What are the possible benefits and risks of participating?
Participants may benefit from continued development of the roots of non-vital teeth, leading to better prognosis and longer tooth durability, in addition to the potential for restoring tooth vitality. One possible risk of participating in this study is the appearance of clinical symptoms, such as pain or swelling. In such cases, conventional treatment will be performed.
Where is the study run from?
The Department of Endodontics, Faculty of Dentistry, Damascus University (Syria)
When is the study starting and how long is it expected to run for?
January 2020 to May 2023
Who is funding the study?
Investigator initiated and funded (Syria)
Who is the main contact?
Alaa Shaker, dr.alaashaker@gmail.com (Syria)
Contact information
Public, Scientific, Principal Investigator
Department of Endodontics, Faculty of Dentistry, Damascus University, Fayez Mansour Street, Al Mazzeh
Damascus
011
Syria
| Phone | +963949826303 |
|---|---|
| alaa1.shaker@damascusuniversity.edu.sy |
Public
Department of Endodontics, Faculty of Dentistry, Damascus University, Fayez Mansour Street, Al Mazzeh
Damascus
011
Syria
| Phone | +963949826303 |
|---|---|
| dr.alaashaker@gmail.com |
Study information
| Study design | Singlecentre interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Revascularization of non-vital immature permanent teeth with two bioceramic cements: a randomized controlled trial |
| Study acronym | BIOCERAMIC |
| Study objectives | The null hypothesis was that there is no difference between both materials (MTA Biorep and Well Root PT) on the clinical and radiographical success of revascularization procedure |
| Ethics approval(s) |
Approved 01/05/2020, Ethics Committee of Damascus University (Mousalam Baroudy Street, Damascus, 011, Syria; +9631133923010; vice.research@damascusuniversity.edu.sy), ref: MD-160124-179 |
| Health condition(s) or problem(s) studied | Treatment of necrotic immature teeth with apical periodontitis |
| Intervention | Twenty non-vital immature permanent anterior teeth with apical periodontitis were included in this study. Samples were randomly distributed at www.randomizer.org into two groups (n=10) based on the used coronal plug materials; group I (GI): Well Root PT (Vericom, Gangwon-Do, Korea), and group II (GII): MTA Biorep (Itena Clinical, Paris, France). Treatment was conducted according to the American Association of Endodontics guidelines (18/05/2021). All patients in both groups were treated with the same protocol except for the application of coronal plug material. The sodium hypochlorite (1.5 %) was used for irrigation and the triple antibiotic paste (5 mg/mL) was used as a medication. The scaffold used was a blood clot. Follow-up was done clinically and radiographically for up to 12 months for the two groups. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The degree of success is measured using the American Association of Endodontists' criterion at baseline and 12 months |
| Secondary outcome measures | The following secondary outcome measures were assessed at baseline and 12 months: 1. Pain on biting is measured by asking the patient if it is present or absent 2. Pain on percussion is measured by tapping the tooth with a mirror 3. Soft tissue swelling is measured using visual examination 4. Sinus tract is measured using visual examination 5. Mobility is measured by applying pressure with two metal instruments 6. Pulp sensitivity is measured using Ethyl Chloride spray 7. Root length is measured radiographically using Image J software 8. Root thickness is measured radiographically using Image J software 9. The area of the periapical lesion is measured radiographically using Image J software |
| Overall study start date | 01/01/2020 |
| Completion date | 01/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 9 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Patients are free from any systemic diseases that may hinder the normal healing process 2. Non-vital permanent anterior teeth with open apex and apical periodontitis 3. Single-rooted teeth 4. The tooth does not require post and core for the final restoration 5. Age range from 9-25 years old |
| Key exclusion criteria | 1. Tooth with vital pulp or complete root formation 2. Tooth with previous endodontic treatment 3. Patients allergic to the medications and antibiotics necessary to complete the treatment 4. Un-cooperative patients |
| Date of first enrolment | 01/07/2020 |
| Date of final enrolment | 15/03/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
[-]
Syria
Sponsor information
University/education
Mousalam Baroudy Street
Damascus
011
Syria
| Phone | +963-11-33923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 10/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Alaa Shaker (dr.alaashaker@gmail.com) |
Editorial Notes
16/01/2024: Study's existence confirmed by the Ethics Committee of Damascus University (Syria)
