Differences in biting behavior in patients with teeth connected in small bridges and teeth standing free adjacent to a dental implant

ISRCTN ISRCTN24104637
DOI https://doi.org/10.1186/ISRCTN24104637
Submission date
08/03/2021
Registration date
01/04/2021
Last edited
30/09/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Patients with a missing tooth may have treatment using a dental bridge, where a false tooth sits in place of the missing tooth and is held in place by crowns (a cap that covers a natural tooth) that have been cemented onto the teeth or implants (replacement teeth surgically placed in the jawbone to serve as the roots of missing teeth) on either side of the gap. It has been shown that patients with implant-supported bridges and tooth-supported bridges on both the lower and upper jaw have a decreased ability to control biting forces associated with holding and splitting food between the teeth, compared to patients with full natural teeth. The reduced sensory capacity observed in patients with dental implants is due to the lack of sensory information that would usually be detected and transmitted by receptors via the root of the teeth. However, patients with tooth-supported bridges show similar reduced sensory capacity, despite these receptors being present in the adjacent teeth.

When replacing missing teeth, an alternative to tooth-supported bridges may be implant-supported prostheses that leave the adjacent teeth free to function as sensors, as required for normal biting function. The primary aim of the study is to investigate the sensory-motor capacity in patients with small tooth-supported resin-bonded bridges and with single implants. Further aims are to evaluate the differences in the patient's assessment of function and aesthetics between the two treatments and also to compare this with the aesthetic evaluation of dental professionals.

Who can participate?
Participants older than 18 years old who lack an upper anterior (incisors or canine) tooth which has been currently replaced with a tooth-supported resin-bonded bridge and planned for treatment with single anterior implants.

What does the study involve?
Participants will receive treatment with single anterior implants. The study will involve the assessment of participants on two occasions, once with the resin-bonded bridge in place and once after treatment with the implant crown in place. Assessment involves the performance of a non-invasive bite test, scanning inside the mouth, having photographs taken, and filling out a questionnaire.

What are the possible benefits and risks of participating?
The benefit of this study is that it may contribute to more knowledge regarding the treatment of tooth loss. There are no risks involved in the study.

Where is the study run from?
Folktandvården Eastmaninstitutet (Sweden)

When is the study starting and how long is it expected to run for?
From March 2016 to August 2022

Who is funding the study?
Karolinska Institutet (Sweden)

Who is the main contact?
Dr Nicole Winitsky, nicole.winitsky@sll.se

Contact information

Dr Nicole Winitsky
Scientific

Dalagatan 11
Stockholm
113 24
Sweden

ORCiD logoORCID ID 0000-0003-3171-6522
Phone +46 709-158258
Email nicole.winitsky@sll.se

Study information

Study designSingle-centre observational cross-sectional case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet
Scientific titleSensory-motoric capacity in patients treated with tooth- and implant-supported restorations
Study acronymSMC-TISR
Study objectivesPatients with non-connected teeth adjacent to single implants are able control their biting behavior better and also rate their sensation of biting and esthetics higher than patients with teeth connected with fixed tooth supported bridges.
Ethics approval(s)Approved 12/11/2018, Regional Ethical Review Board Stockholm (Tomtebodavägen 18A, 171 65 Solna, Sweden; +46 (0)8-524 870 00; kansli@stockholm.epn.se), ref: 2018/1677-31/1
Health condition(s) or problem(s) studiedSingle anterior tooth loss in the upper jaw
InterventionPatients planned for single implant treatment of central incisors, at present wearing a resin-bonded bridge, were included in the study. The same sensory-motoric bite-test was run twice. Once prior to implant treatment with the resin-bonded bridge in place and once after implant treatment has been performed. The patients were used as their own controls. Besides biting and force measurements, the patients were scanned with an intraoral scanner, photographed and questionnaires concerning function and aesthetics were filled in by the patient. The aesthetic evaluation will also be performed by professionals.
Intervention typeBehavioural
Primary outcome measure1. Control of biting behavior measured using a custom-built apparatus (Umeå University, Physiology section, IBM, Umeå, Sweden) invented to measure bite forces during hold-and-split tasks before and after the implant treatment
2. Patient Reported Outcome Measure (PROM) of biting measured using a questionnaire before and after the implant treatment
Secondary outcome measuresAesthetics evaluated by patients and professionals using questionnaires and a visual analogue rating scale (VAS) and Pink Esthetic Score (PES)/White Esthetic Score (WES) before and after the implant treatment
Overall study start date18/03/2016
Completion date23/08/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsAt least 14 patients
Key inclusion criteria1. Missing a single tooth in position 11 or 21
2. Wearing a resin-bonded bridge planned for single implant treatment
3. Aged ≥18 years
Key exclusion criteriaNut allergy
Date of first enrolment08/12/2020
Date of final enrolment23/08/2022

Locations

Countries of recruitment

  • Sweden

Study participating centres

Folktandvården Eastmaninstitutet
Dalagatan 11
Stockholm
113 24
Sweden
Uppsala Käkkrirurgiska center
Vaksalagatan 8
Uppsala
753 20
Sweden

Sponsor information

Folktandvården Stockholm AB
Hospital/treatment centre

Magnus Ladulåsgatan 65
Stockholm
118 27
Sweden

Phone +46 (0)8-123 166 00
Email pia.skott@sll.se
Website https://www.folktandvardenstockholm.se

Funders

Funder type

University/education

Karolinska Institutet
Government organisation / Local government
Alternative name(s)
Karolinska Institute, KI
Location
Sweden

Results and Publications

Intention to publish date12/12/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPlanned Publication in a high-impact peer-review journal during 2022.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. All of the individual participant data collected during the trial will be made available through the BIOVIA Notebook 2020 SP2- (ELN- The electronic notebook), after deidentification, immediately following publication with no end date. The data will be shared upon request with researchers who provide a methodologically sound proposal. Contact person Dr Nicole Winitsky. Consent from participants has been signed prior to the gathering of data and all information was anonymized.

Additional documents will be made available through the BIOVIA Notebook 2020 SP2- (ELN- The electronic notebook) and possible to view upon request via the details above.

Editorial Notes

30/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2021 to 23/08/2022.
2. The overall trial end date was changed from 12/05/2022 to 23/08/2022.
3. Uppsala Käkkrirurgiska Center was added as a trial participating centre.
15/03/2021: Trial’s existence confirmed by Regional Ethical Review Board Stockholm.