Can new dental fillings induce regeneration of damaged teeth?
| ISRCTN | ISRCTN48235766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48235766 |
- Submission date
- 16/04/2022
- Registration date
- 19/05/2022
- Last edited
- 05/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The purpose of this study is to investigate a potential therapeutic role for a new group of dental filling materials – Biodentine and ProRoot MTA – in stimulating the repair of the dental pulp or ‘nerve’ of the tooth. This material has recently demonstrated benefits over traditionally used filling materials and has been now been marketed specifically for its role in treating deep decay and exposed pulp tissue. The tooth which you are to have extracted can be used to investigate this potential.
Who can participate?
Male or female aged 10-60 years (patients under 18 years with the consent of parent/guardian).
What does the study involve?
Participants will be randomly allocated to receive a direct pulp capping procedure using MTA or Biodentine. After 6 months the tooth is removed for evaluation.
What are the possible benefits and risks of participating?
There are no adverse risks.
There are general benefits in that you will be contributing to original research in an area with a potential therapeutic benefit for patient care. There are no risks from participation.
Where is the study run from?
Dublin Dental University Hospital (Ireland)
When is the study starting and how long does it run for?
April 2017 to May 2022
Who is funding the study?
Trinity College Dublin (Ireland)
Who is the main contact?
Professor Hal Duncan (Hal.Duncan@dental.tcd.ie)
Contact information
Principal Investigator
Dublin Dental University Hospital
Dublin
Dublin 2
Ireland
 ORCID ID |
0000-0001-8690-2379 |
|---|---|
| Phone | +353 862209219 |
| Hal.Duncan@dental.tcd.ie |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | 41584 PIS 01Mar2017.pdf |
| Scientific title | Experimental pulp capping with hydraulic calcium silicate cements induces a range of responses including regeneration of tubular dentine |
| Study acronym | Nil known |
| Study objectives | The objectives were to study the nature and the quality of the mineralised bridge and soft tissue response after application of Biodentine and MTA after longer term 6-month intervals; to analyse the presence of bacteria adjacent to the capping material and in the pulp tissue and finally to assess the morphological nature of the cells in contact with the mineralised bridge. |
| Ethics approval(s) | Approved 25/04/2017, St James’s Hospital REC (Tallaght Hospital, Tallaght, Dublin 24, Ireland; +353 1 4142199; Sadhbh.ONeill@tuh.ie), ref: 2017/04/01 |
| Health condition(s) or problem(s) studied | Treatment of disease of the dental pulp |
| Intervention | Direct pulp capping procedure using MTA or Biodentine. MTA is the control/gold standard. After 6 months the teeth were extracted and histologically evaluated. Random sequence generation was performed using a computer-generated number (www.random.org) and to provide allocation concealment a dental nurse not involved in the recruitment of patients carried out the online randomisation. The virtual coin was ‘flipped’ before each appointment to decide which material should be used. |
| Intervention type | Other |
| Primary outcome measure | Dental hard tissue bridge formation: Histology at 6 months |
| Secondary outcome measures | Discoloration: Photographed at 6 months |
| Overall study start date | 25/04/2017 |
| Completion date | 01/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 16 |
| Total final enrolment | 21 |
| Key inclusion criteria | Male or female patients aged between 14-50 years (patients under 18 years required the consent of a parent/guardian) with an experimental tooth responding positively to pulp sensibility testing (cold thermal and electric), which was scheduled for extraction. The tooth was to be extracted for either orthodontic or prevention reasons and needed to be completely caries-free. |
| Key exclusion criteria | Teeth excluded from participation in the trial were: non-vital or carious teeth, teeth that could not be isolated with a rubber dam or teeth that required sectioning of the roots in order to be extracted. |
| Date of first enrolment | 01/08/2017 |
| Date of final enrolment | 01/06/2021 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Division of Restorative Dentistry & Periodontology
Lincoln Place
Dublin
Dublin 2
Ireland
Sponsor information
Hospital/treatment centre
Lincoln Place
Dublin
Dublin 2
Ireland
| Phone | +353 16127356 |
|---|---|
| Blanaid.Daly@dental.tcd.ie | |
| Website | http://www.dentalhospital.ie/ |
"ROR" |
https://ror.org/03v4j0e89 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in high impact factor journal 'International Endodontic Journal' and international presentation |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/03/2017 | 20/04/2022 | No | Yes |
Additional files
Editorial Notes
05/07/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/01/2022 to 01/05/2022.
2. The intention to publish date was changed from 01/07/2022 to 01/07/2023.
3. The plain English summary was updated to reflect these changes.
20/04/2022: Trial's existence confirmed by St James’s Hospital REC
