The effects of customized dental implant healing caps on tissues around the implant
| ISRCTN | ISRCTN98477184 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98477184 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1807/2017 |
| Sponsor | Medical University of Vienna |
| Funder | MIS Implants Technologies Ltd |
- Submission date
- 28/01/2022
- Registration date
- 18/05/2022
- Last edited
- 28/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Healing abutments (also called healing cuffs or caps) help the gum tissue around dental implants to heal. Frequent changes of healing abutments have been associated with negative effects on wound healing around the implant. The aim of this study is to compare the levels of markers of inflammation and tissue destruction around implants with customized and standard healing abutments.
Who can participate?
Patients with partial posterior edentulism, aged over 18 years, adequate bone quality and availabilty for implant placement, no signs of inflammation in the region where implant placement is planned, good systemic health conditions and stable occlusion
What does the study involve?
Implants are randomly allocated into one of two groups. One group of implants will be fitted with a one-piece titanium customized abutment after implant insertion. Control group implants will be fitted with standard healing abutments. Mouth fluid collection and x-rays will be carried out at suture removal at 1 week after implant placement, following crown delivery after 3 months, and at 6 months follow-up. Intraoral scanning will be performed to compare the changes in the soft tissue around the implant.
What are the possible benefits and risks of participating?
There are no risks expected for participants.
Where is the study run from?
Medical University of Vienna (Austria)
When is the study starting and how long is it expected to run for?
August 2017 to June 2022
Who is funding the study?
MIS Implants Technologies Ltd (UK)
Who is the main contact?
Dr Christian Wehner
christian.wehner@meduniwien.ac.at
Contact information
Principal investigator
Sensengasse 2a
Vienna
1090
Austria
| Phone | +43 (0)1 40070 4720 |
|---|---|
| christian.wehner@meduniwien.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-centre randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effects of customized CAD/CAM abutments on cytokine levels in peri-implant crevicular fluid during early implant healing: a pilot study |
| Study objectives | It is hypothesized that the use of customized healing abutments for dental implants induces an altered inflammatory response compared to standard healing abutments. |
| Ethics approval(s) | Approved 05/09/2017, Ethics Committee of the Medical University of Vienna (Borschkegasse 8b/6, 1090 Vienna, Austria; +43(0)1 404 00 21470; ethik-kom@meduniwien.ac.at), ref: 1807/2017 |
| Health condition(s) or problem(s) studied | Need for dental implant placement to replace missing tooth/teeth |
| Intervention | The aim of this exploratory randomized, controlled clinical trial is to assess the effect of one-piece individualized titanium abutments on biomarkers associated with inflammation and tissue degradation in peri-implant crevicular fluid (PICF) as well as marginal bone levels during the early healing phase. The researchers plan to place a total of 30 dental implants in patients with partial posterior edentulism. Implant sites are randomized using online available tools (https://www.randomizer.org/) to either receive individual or standard healing abutments. 15 implants will receive a one-piece titanium abutment that will be fabricated using computer-aided design/computer-aided manufacturing (CAD/CAM) subsequently after implant insertion. Control group implants (n=15) will be provided with standard healing abutments. Peri-implant sulcus fluid collection, standardized periapical radiographs applying parallel technique and intraoral scanning will be carried out at suture removal 1 week after implant placement (T1), following crown delivery after 3 months (T2), and at 6 months follow-up (T3). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Peri-implant inflammation and tissue destruction measured by levels of biomarkers (pg/ml) in peri-implant crevicular fluid (PICF) at suture removal, at crown delivery and at 6 months follow-up |
| Key secondary outcome measure(s) |
Marginal bone loss (mm) measured radiographically at suture removal, at crown delivery and at 6 months follow-up |
| Completion date | 01/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 22 |
| Total final enrolment | 22 |
| Key inclusion criteria | 1. Aged >18 years old 2. One or more missing teeth in the molar region of the upper and/or lower jaw 3. Adequate bone quality and availability for implant placement 4. No signs of inflammation in the region where implant placement is planned 5. Good systemic health conditions 6. Stable occlusion 7. Willing to participate and attend follow-up appointments |
| Key exclusion criteria | 1. Presence of untreated periodontitis 2. Smokers (>10 cigarettes per day) 3. Alcoholism or drug abuse, history of chemotherapy or radiation 4. Diabetes with >7.5 HbA1c |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 01/01/2022 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at the Division of Conservative Dentistry, University Clinic of Dentistry, Medical University of Vienna. For further information please contact Dr Christian Wehner (christian.wehner@meduniwien.ac.at). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/12/2022 | 28/12/2022 | Yes | No | |
| Protocol file | 22/08/2022 | No | No |
Additional files
- ISRCTN98477184_PROTOCOL.pdf
- Protocol file
Editorial Notes
28/12/2022: Publication reference added.
22/08/2022: Protocol file uploaded.
09/06/2022: The final enrolment has been added.
31/01/2022: Trial's existence confirmed by the Ethics Committee of the Medical University of Vienna.
