3D-printable biopolymers and their use in dentistry
| ISRCTN | ISRCTN12199305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12199305 |
- Submission date
- 02/03/2024
- Registration date
- 04/03/2024
- Last edited
- 04/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
All the patients enrolled in the study had a financial convenience , since .
The study was conducted in and lasted from June 2023 to July 2023.
No funds were received for the trial and the responsible was the adjunct professor
Background and study aims
The goal of this clinical study is to assess how well 3D printed biopolymers, mixed with materials that promote bone growth (beta-tricalcium phosphate and hydroxyapatite), work for closing soft tissues after having a tooth removed.
Who can participate?
The study was opened to all patients requiring a tooth extraction
What does the study involve?
The procedure involved removing the tooth, and then randomly choosing whether to close the socket using a 3D printed disk made from two types of biodegradable materials: polylactic acid and polycaprolactone. Both materials were mixed with synthetic ceramic substances that promote bone growth, specifically 10% hydroxyapatite and 20% beta tricalcium phosphate, respectively.
What are the possible benefits and risks of participating?
The procedure was done free of charge.
No risks
Where is the study run from?
Trisakti University (Indonesia)
When is the study starting and how long is it expected to run for?
May 2023 to July 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Nicola De Angelis, n.deangelis74@gmail.com
Contact information
Public, Scientific, Principal Investigator
Largo R. benzi 10
Genoa
16121
Italy
 ORCID ID |
0000-0001-8622-4328 |
|---|---|
| Phone | +39 3474188180 |
| nicolaantonio.deangelis@edu.unige.it |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | 45125 PIS.pdf |
| Scientific title | 3D-printable biopolymers for socket preservation technique: soft tissues response. A randomized clinical trial. |
| Study hypothesis | Soft tissues response after tooth extraction is the same whether the socket is sealed by a polymeric 3D printed disk or is left open to heal |
| Ethics approval(s) |
Approved 03/05/2023, Ethics Committee for Health Research Faculty of Dentistry, Universitas Trisakti (Jl. Kyai Tapa No.260 4, RT.4/RW.16, Jakarta, 11440, Indonesia; +62 21 566 3232; komisietikfkg@trisakti.ac.id), ref: 641/S3/KEPK/FKG/5/2023 |
| Condition | Soft tissues response following teeth extractions |
| Intervention | All the extractions were performed without flap elevation without any antibiotic prophylaxis. A careful cleaning of the socket was done in order to exclude the possible presence of inflammatory tissue, without grafting any additional bone substitute. Once tooth extraction was completed, the operator opened a sealed envelope containing the result of the randomization in order to include the patient in one of the following study groups: TEST 1: a 3D printed disk of poli-D-lactic acid with 10% of hydroxyapatite had to be trimmed inside the gingival margin and ensured with a crossed mattress suture. TEST 2: a 3D printed disk of poli- ε caprolactone with 20% of β-tricalcium phosphate had to be trimmed inside the gingival margin and ensured with a crossed mattress suture. CONTROL: extraction left to heal without any graft materials. Only a collagen sponge was used in case of excessive bleeding. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Soft tissues closure was measured at the baseline and 30 days after the procedure with intraoral photographs |
| Secondary outcome measures | Bone formation was measured at the baseline at 30 days after the procedure with intra-oral periapical X-rays |
| Overall study start date | 03/05/2023 |
| Overall study end date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 39 |
| Total final enrolment | 39 |
| Participant inclusion criteria | 1. Medically healthy 2. No assumption of bifosphonates 3. No or light – medium smokers (maximum 10 cigarettes/day) 4. Requiring a tooth extraction |
| Participant exclusion criteria | 1. Pregnancy and lactation 2. Patients with signs of acute infection at the extraction site |
| Recruitment start date | 01/06/2023 |
| Recruitment end date | 30/06/2023 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
11440
Indonesia
Sponsor information
University/education
Jalan Kyai Tapa No. 1 Grogol
Jakarta
11440
Indonesia
| Phone | +62 21 566 3232 |
|---|---|
| humas@trisakti.ac.id | |
| Website | http://www.mm.trisakti.ac.id/ |
"ROR" |
https://ror.org/019fnr381 |
University/education
Largo R. benzi 10
Genoa
16121
Italy
| Phone | +39 144320305 |
|---|---|
| 681535@unige.it | |
| Website | http://www.unige.it/ |
|
"ROR" |
https://ror.org/0107c5v14 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/03/2024 |
|---|---|
| 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 the study will be amiable upon request from Nicola De Angelis n.deangelis74@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/03/2024 | No | Yes | ||
| Protocol file | version 1 | 04/03/2024 | No | No |
Additional files
Editorial Notes
04/03/2024: Trial's existence confirmed by Ethics Committee for Health Research Faculty of Dentistry, Universitas Trisakti.
