The performance of a two-unit bridge supported by one implant in the lateral part of the upper and lower jaw
ISRCTN | ISRCTN79055740 |
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DOI | https://doi.org/10.1186/ISRCTN79055740 |
Secondary identifying numbers | METc UMCG RR201800656 |
- Submission date
- 10/03/2021
- Registration date
- 14/03/2021
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Sometimes it is impossible or undesirable to place two adjacent dental implants in a diastema (the space or gap between two teeth) to replace two teeth. Several factors could play a role like a shortage of bone, a shortage of the length of the diastema or financial constraints. There is a lack of evidence for this treatment. Besides, no study has ever reported on patient satisfaction with this treatment to the best of the researchers' knowledge. Therefore, the aim of this study is to evaluate survival, clinical performance, complications and patient-reported outcomes of single implant-supported two-unit cantilever fixed partial denture in the posterior region of the mouth.
Who can participate?
Patients who received a single implant-supported fixed partial denture with a cantilever in the posterior region between January 2004 and February 2018
What does the study involve?
The survival rate of the implants and the fixed partial dentures and data regarding the marginal bone level, presence of plaque, calculus (hardened plaque), bleeding on probing, mucosal health, pocket probing depth and patient satisfaction are collected during an evaluation visit. Complications are recorded from their medical records.
What are the possible benefits and risks of participating?
All patients were scheduled for a regular check-up (care as usual). The patients were able to give their opinion on the treatment and results (retrospectively) by filling in two questionnaires. No risks were involved.
Where is the study run from?
University Medical Center of Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
September 2018 to July 2019
Who is funding the study?
University Medical Center of Groningen (Netherlands)
Who is the main contact?
Dr C Jensen-Louwerse
c.jensen@umcg.nl
Contact information
Scientific
Antonius Deusinglaan 1
Groningen
9713AV
Netherlands
0000-0002-3483-5220 | |
Phone | +31 (0)50 3616274 |
c.jensen@umcg.nl |
Study information
Study design | Retrospective case series |
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Primary study design | Observational |
Secondary study design | Case series |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | No participant information sheet available |
Scientific title | Single implant-supported two-unit cantilever fixed partial dentures in the posterior region: a retrospective case series with a mean follow-up of 6.5 years |
Study objectives | The aim of this retrospective study is to evaluate survival, clinical performance, complications and patient-reported outcomes of single implant-supported two-unit cantilever fixed partial dentures (FPD) in the posterior region. |
Ethics approval(s) | The Medical Ethical Committee of the University Medical Center Groningen considered this retrospective case series study not to be subject to the Medical Research Involving Human Subjects Act (METc RR-Number 201800656) |
Health condition(s) or problem(s) studied | Evaluation of the functioning of implant-supported cantilever fixed partial dentures |
Intervention | Patients who received a single implant-supported fixed partial denture with a cantilever in the posterior region between January 2004 and February 2018 are included. The survival rate of the implants and the fixed partial dentures and data regarding the marginal bone level, presence of plaque, calculus, bleeding on probing, mucosa health, pocket probing depth and patient satisfaction are collected during an evaluation visit. Complications are recorded from the medical records. The average follow-up period of this particular retrospective study is 6.5 ± 4.8 years at the time of data collection. |
Intervention type | Device |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | Survival rate of implants assessed using clinical examination at the follow-up evaluation |
Secondary outcome measures | 1. Marginal bone level (MBL) measured using radiographic assessments at baseline and during the follow-up evaluation 2. Clinical assessments by one examiner at the follow-up evaluation: 2.1. Plaque assessed per implant using the modified plaque index 2.2. Presence of calculus observed during clinical examination 2.3. Bleeding assessed per implant using the modified sulcus bleeding index 2.4. Gingival health assessed per implant using the gingival index 2.5. Probing depth assessed at four sites per implant using a manual standardized pressure periodontal probe (Click-Probe®, Kerr, Bioggio, Switzerland) measuring to the nearest 1 mm 3. Complications recorded from medical records at the follow-up evaluation 4. Patients’ satisfaction measured using OHIP-NL49 and VAS questionnaire at the follow-up evaluation |
Overall study start date | 01/09/2018 |
Completion date | 01/07/2019 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 25 |
Total final enrolment | 23 |
Key inclusion criteria | All patients treated with a single implant-supported two-unit cantilever FPD in the posterior region of maxilla or mandible between the period January 1st, 2004 and January 1st, 2018 in a private referral practice in Apeldoorn, The Netherlands. The inclusion criteria for the study are: 1. One dental implant restored with a crown with one cantilever unit positioned mesially or distally, in the posterior region of maxilla or mandible 2. Presence of antagonistic teeth 3. Follow-up period at least 1 year after placement of the restoration 4. Presence of a radiograph taken directly after placement of the implant |
Key exclusion criteria | Does not meet the inclusion criteria |
Date of first enrolment | 01/10/2018 |
Date of final enrolment | 01/04/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Apeldoorn
7315 CA
Netherlands
Sponsor information
Hospital/treatment centre
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Phone | +31 (0)50 3616161 |
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info@umcg.nl | |
Website | http://www.umcg.nl/EN |
https://ror.org/03cv38k47 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/10/2021 |
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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 | Data will be shared on a personal basis. If a researcher is interested in the data they can contact Dr C Jensen-Louwerse (c.jensen@umcg.nl). Patients were informed verbally and in writing about the study and signed the informed consent form. All data is stored in Red Cap and processed anonymously. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 19/08/2021 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: Publication reference added.
12/03/2021: Trial's existence confirmed by the Medical Ethical Committee of the University Medical Centre Groningen.