Clinical evaluation of polyetherketoneketone (PEKK) post and core system in restoring teeth that have had tooth pulp treatment
| ISRCTN | ISRCTN13456471 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13456471 |
| Secondary identifying numbers | 2164 |
- Submission date
- 05/10/2019
- Registration date
- 14/10/2019
- Last edited
- 05/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Restorations in compromised endodontically treated teeth aim to protect the remaining dental tissue from fracture, prevent the return of sepsis to the root canal system, and compensate for lost dental structures. There are several ways to restore compromised endodontically treated teeth, one of them is called post and core. Several factors affect the fracture resistance of teeth restored with post and core. Fibreglass reinforced resin posts are often prefabricated posts, limiting their fitting of the channel's precise shape. Recently a new dental material has been introduced called polyetherketoneketone (PEKK). This material has similar characteristics to human bone and is shock absorbent and lightweight. The aim of this study is to compare patients receiving treatment with a one-piece milled post and core made from PEKK and prefabricated fibre posts.
Who can participate?
Adults with destroyed lower premolars
What does the study involve?
Chosen teeth are randomly allocated into two groups to undergo restorations supported with either a one-piece milled post and core made from PEKK or prefabricated fibre posts. All teeth are assessed clinically at 3, 6, and 12 months and radiographically at 6 and 12 months after treatment.
What are the possible benefits and risks of participation?
The treatment may introduce a new material for fabricating posts and cores. There are no known risks to participants as any failed treatments will be re-done using another method.
Where is the study run from?
Tishreen University (Syria)
When is the study starting and how long is it expected to run for?
May 2019 to December 2021
Who is funding the study?
Tishreen University (Syria)
Who is the main contact?
Dr Naif Ghanem
dr.naifgh1210@gmail.com
Dr Naser Baherli
Naser.Bahrli059@outlook.com
Contact information
Scientific
Alzeraa
lattakia
00963
Syria
 ORCID ID |
0000-0003-3403-958X |
|---|---|
| Phone | +992436995 |
| naif.ghanem@tishreen.edu.sy |
Study information
| Study design | Randomized two parallel-group clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Evaluating the success of post and core system fabricated by polyetherketoneketone (PEKK) material in restoring endodontically treated teeth: a randomized controlled trial |
| Study acronym | PEKK_ post and core_ endodontically treated teeth |
| Study objectives | Current study hypothesis as of 19/04/2021: Null hypothesis: There are no differences in survival rates between the two groups: one-piece milled post and core from (PEKK), and prefabricated fiber posts. Alternative hypothesis: There are differences in survival rates between the two groups: one-piece milled post and core from (PEKK), and prefabricated fiber posts. Previous study hypothesis: Null hypothesis: There are no differences in survival rates between the three groups: one-piece milled post and core from (PEKK), one-piece milled post and core from fiber-reinforced composite blocks and prefabricated fiber posts. Alternative hypothesis: There are differences in survival rates between the three groups: one-piece milled post and core from (PEKK), one-piece milled post and core from fiber-reinforced composite blocks and prefabricated fiber posts. |
| Ethics approval(s) | Approved 02/04/2019, The Institutional Review Board of Tishreen University (Tishreen University, Faculty of Dentistry, Department of Fixed Prosthodontics), No. 2164 |
| Health condition(s) or problem(s) studied | Damaged endodontically treated lower premolars with two or fewer remaining cavity walls that need post and core |
| Intervention | Current interventions as of 19/04/2021: A randomized two parallel-groups clinical trial was designed to evaluate the differences in survival rates between the two groups: Group 1: one-piece milled post and core from (PEKK) Group 2: prefabricated fiber posts (control group) According to the patient identification number, stratified random allocation was performed based on a website (Randomization.com) to achieve balance between groups in size. Double blinding will be used (patient and examiner). The control group is the group of prefabricated fiber posts. Previous interventions: A randomized three parallel-groups clinical trial was designed to evaluate the differences in survival rates between the three groups: Group 1: one-piece milled post and core from (PEKK) Group 2: one-piece milled post and core from fibre-reinforced composite blocks. Group 3: prefabricated fiber posts (control group) According to the patient identification number, restricted random allocation was performed by blocking with a block length of 3 and 6 based on a the website (Randomization.com) to achieve balance between groups in size. Double blinding will be used (patient and examiner). The control group is the group of prefabricated fiber posts. The primary endpoint was the loss of restoration for any reason. Secondary endpoints were tooth loss, post debonding, post fracture, vertical or horizontal root fracture, endodontic or periradicular conditions requiring endodontic retreatment, secondary caries and failure of core build-up, and loss of restoration because of technical failures. The patients were recalled at 3, 6, and 12 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The loss of restoration for any reason, conducted by using of an explorer at 3, 6, and 12 months post-treatment and periapical radiographic examination performed by use of a paralleling technique at 6 and 12 months post-treatment |
| Secondary outcome measures | Conducted by visual inspection at 3, 6, and 12 months post-treatment 1. Tooth loss 2. Post debonding 3. Post fracture 4. Vertical or horizontal root fracture 5. Endodontic or periradicular conditions requiring endodontic retreatment 6. Secondary caries 7. Failure of core build-up 8. Loss of restoration because of technical failures |
| Overall study start date | 02/06/2019 |
| Completion date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Patients older than 18 years 2. Patients are required to have one mandibular premolar for which endodontic treatment is indicated 3. The remaining cavity walls of the premolar after endodontic treatment two or fewer 4. No or treated periodontitis with a maximum probing depth of 4 mm and no bleeding on probing 5. Tooth mobility not more than score 1 6. The premolar are required to be in occlusal function with a natural tooth following restoration and none are used as abutments for fixed or removable prostheses 7. A willingness to return for a follow-up examination for at least 1 year |
| Key exclusion criteria | 1. Tooth will aim to serve as an abutment for fixed or removable prostheses 2. Medical contraindications to dental treatment 3. Poor oral hygiene 4. Teeth with failed endodontic therapy 5. Patients with severe parafunctional habits |
| Date of first enrolment | 01/01/2020 |
| Date of final enrolment | 01/09/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Lattakia
00963
Syria
Sponsor information
University/education
Alzeraa
Lattakia
00963
Syria
| Phone | +963 (0)41420291 |
|---|---|
| dentistry@tishreen.edu.sy | |
| Website | http://www.tishreen.edu.sy/ |
"ROR" |
https://ror.org/04nqts970 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 19/04/2021: The results will be published in one of the prosthodontic journals which are related to the Scopus group. The results that will be published are: 1. Survival rates of (PEKK) posts and cores 2. A comparison between one-piece milled (PEKK) posts and cores, and prefabricated fiber posts (control group). Previous publication and dissemination plan: The results will be published in one of the prosthodontic journals which are related to the Scopus group. The results that will be published are: 1. Survival rates of (PEKK) posts and cores 2. A comparative study about the two materials that are used to fabricate one-piece milled posts and cores |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2024 | 05/03/2024 | Yes | No |
Editorial Notes
05/03/2024: Publication reference and total final enrolment added.
26/05/2022: Ethics approval details updated.
19/04/2021: The following changes were made to the trial record:
1. The plain English summary, hypothesis, interventions and publication and dissemination plan were updated.
2. The target number of participants was changed from 60 to 30.
3. The study design was changed from 'Randomized three parallel-groups clinical trial' to 'Randomized two parallel-group clinical trial'.
14/10/2019: Trial’s existence confirmed by Tishreen University
