Contact information
Type
Scientific
Primary contact
Prof Jocelyne Feine
ORCID ID
Contact details
Oral Health and Society Research Unit
Suite #101
Faculty of Dentistry
McGill University
3550 University Street
Montreal
Quebec
H3A 2A7
Canada
+1 514 398 7203 ext. 00052
jocelyne.feine@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UCT-36052
Study information
Scientific title
The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals: a randomised controlled trial
Acronym
SIN II
Study hypothesis
Null Hypothesis:
That there will be no difference in nutritional status measured by serum homocysteine levels in elderly edentulous males and females wearing mandibular 2-implant overdentures and those wearing mandibular conventional dentures at six months following delivery of the prostheses.
Ethics approval
McGill University Faculty of Medicine IRB, original approval received November 15, 2002; renewed yearly; latest renewal approved 29 August 2006 (study number A08-M75-02B).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Edentulism (lack of all teeth)
Intervention
Control: Complete conventional dentures
Experimental: Mandibular 2-implant overdenture with ball attachments and maxillary conventional denture
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Serum level of homocysteine.
Secondary outcome measures
1. Patient satisfaction
2. Vitamin status
3. Changes in serum albumin
4. Changes in dietary habits
5. Changes in function
6. Cost effectiveness
Overall trial start date
01/09/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female seniors aged 65 and older
2. Completely edentulous for a minimum of five years
3. Wishing to replace existing conventional dentures
4. An adequate understanding of written and spoken English or French
5. Able to understand and respond to questionnaires used in the study
6. Willing and able to accept the protocol and give informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
254
Participant exclusion criteria
1. Insufficient bone to place two implants in the anterior mandible
2. Other oral conditions that preclude immediate prosthetic treatment
3. Acute or chronic symptoms of temporomandibular disorders
4. History of radiation therapy to the orofacial region
5. Systemic or neurological disease that contraindicate implant surgery
6. Any neoplasia diagnosed less than five years previously
7. Body mass index (BMI) less than 20 or greater than 32 kg/m^2
8. Score of 20 or less on the Mini-Mental State Evaluation
9. Taking any of the following which will affect blood nutrient concentrations:
9.1. Dietary supplements
9.2. Anti-neoplastic medication
9.3. Phenytoin or corticosteroids
9.4. Insulin
10. Other conditions that jeopardise surgical treatment (e.g. alcoholism)
11. Psychological or psychiatric conditions that could influence diet and reaction to treatment
Recruitment start date
01/09/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Oral Health and Society Research Unit
Montreal, Quebec
H3A 2A7
Canada
Sponsor information
Organisation
McGill University (Canada)
Sponsor details
845 Sherbrooke Street West
James Administration Bldg.
Suite 429
Montreal
Quebec
H3A 2T5
Canada
+1 514 398 4455
jacques.hurtubise@mcgill.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-36052)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Straumann Canada (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 etiological factor results in: http://www.ncbi.nlm.nih.gov/pubmed/18434573
2. 2008 sex differences results in: http://www.ncbi.nlm.nih.gov/pubmed/18394770
3. 2008 research approaches in: http://www.ncbi.nlm.nih.gov/pubmed/19177731
4. 2009 methodological issues in: http://www.ncbi.nlm.nih.gov/pubmed/19157673
5. 2011 mandibular bone height results in: http://www.ncbi.nlm.nih.gov/pubmed/20708062
6. 2012 implant overdentures and nutrition results in: http://www.ncbi.nlm.nih.gov/pubmed/21951464
7. 2012 treatment satisfaction results in: http://www.ncbi.nlm.nih.gov/pubmed/22522414
8. 2013 dietary intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24158335
Publication citations
-
Etiological factor results
Emami E, de Grandmont P, Rompré PH, Barbeau J, Pan S, Feine JS, Favoring trauma as an etiological factor in denture stomatitis., J. Dent. Res., 2008, 87, 5, 440-444.
-
Sex differences results
Pan S, Awad M, Thomason JM, Dufresne E, Kobayashi T, Kimoto S, Wollin SD, Feine JS, Sex differences in denture satisfaction., J Dent, 2008, 36, 5, 301-308, doi: 10.1016/j.jdent.2008.02.009.
-
Research approaches
Emami E, de Grandmont P, Feine JS, Research approaches in prosthodontics., Eur J Prosthodont Restor Dent, 2008, 16, 4, 185-189.
-
Methodological issues
Moynihan P, Thomason M, Walls A, Gray-Donald K, Morais JA, Ghanem H, Wollin S, Ellis J, Steele J, Lund J, Feine J, Researching the impact of oral health on diet and nutritional status: methodological issues., J Dent, 2009, 37, 4, 237-249, doi: 10.1016/j.jdent.2008.12.003.
-
Mandibular bone height results
Pan S, Dagenais M, Thomason JM, Awad M, Emami E, Kimoto S, Wollin SD, Feine JS, Does mandibular edentulous bone height affect prosthetic treatment success?, J Dent, 2010, 38, 11, 899-907, doi: 10.1016/j.jdent.2010.08.002.
-
Implant overdentures and nutrition results
Awad MA, Morais JA, Wollin S, Khalil A, Gray-Donald K, Feine JS, Implant overdentures and nutrition: a randomized controlled trial., J. Dent. Res., 2012, 91, 1, 39-46, doi: 10.1177/0022034511423396.
-
Treatment satisfaction results
Michaud PL, de Grandmont P, Feine JS, Emami E, Measuring patient-based outcomes: is treatment satisfaction associated with oral health-related quality of life?, J Dent, 2012, 40, 8, 624-631, doi: 10.1016/j.jdent.2012.04.007.
-
Dietary intake results
Hamdan NM, Gray-Donald K, Awad MA, Johnson-Down L, Wollin S, Feine JS, Do implant overdentures improve dietary intake? A randomized clinical trial., J. Dent. Res., 2013, 92, 12 Suppl, 146S-53S, doi: 10.1177/0022034513504948.