The performance of a two-unit bridge supported by one implant in the lateral part of the upper and lower jaw

ISRCTN ISRCTN79055740
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Charlotte Jensen-Louwerse
Scientific

Antonius Deusinglaan 1
Groningen
9713AV
Netherlands

ORCiD logoORCID ID 0000-0002-3483-5220
Phone +31 (0)50 3616274
Email c.jensen@umcg.nl

Study information

Study designRetrospective case series
Primary study designObservational
Secondary study designCase series
Study setting(s)Other
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleSingle 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 objectivesThe 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) studiedEvaluation of the functioning of implant-supported cantilever fixed partial dentures
InterventionPatients 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureSurvival rate of implants assessed using clinical examination at the follow-up evaluation
Secondary outcome measures1. 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 date01/09/2018
Completion date01/07/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants25
Total final enrolment23
Key inclusion criteriaAll 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 criteriaDoes not meet the inclusion criteria
Date of first enrolment01/10/2018
Date of final enrolment01/04/2019

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Private referral practice in Apeldoorn: "De Mondhoek"
Zwolse Binnenweg 5
Apeldoorn
7315 CA
Netherlands

Sponsor information

University Medical Center Groningen
Hospital/treatment centre

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone +31 (0)50 3616161
Email info@umcg.nl
Website http://www.umcg.nl/EN
ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/10/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planData 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?
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.