The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals

ISRCTN	ISRCTN24273915
DOI	https://doi.org/10.1186/ISRCTN24273915
Secondary identifying numbers	UCT-36052

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jocelyne Feine
Scientific

Oral Health and Society Research Unit
Suite #101
Faculty of Dentistry
McGill University
3550 University Street
Montreal, Quebec
H3A 2A7
Canada

Phone	+1 514 398 7203 ext. 00052
Email	jocelyne.feine@mcgill.ca

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of improved oral prostheses on the nutritional state of elderly edentulous individuals: a randomised controlled trial
Study acronym	SIN II
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2002
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	254
Key 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
Key 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
Date of first enrolment	01/09/2002
Date of final enrolment	31/12/2006

Oral Health and Society Research Unit

Montreal, Quebec
H3A 2A7
Canada

McGill University (Canada)
University/education

845 Sherbrooke Street West
James Administration Bldg., Suite 429
Montreal, Quebec
H3A 2T5
Canada

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-36052)

No information available

Straumann Canada (Canada)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	etiological factor results	01/05/2008	Yes	No
Results article	sex differences results	01/05/2008	Yes	No
Other publications	research approaches	01/12/2008	Yes	No
Other publications	methodological issues	01/04/2009	Yes	No
Results article	mandibular bone height results	01/11/2010	Yes	No
Results article	implant overdentures and nutrition results	01/01/2012	Yes	No
Results article	treatment satisfaction results	01/08/2012	Yes	No
Results article	dietary intake results	01/12/2013	Yes	No