Condition category
Oral Health
Date applied
20/10/2004
Date assigned
28/07/2005
Last edited
29/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mcgill.ca/

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

  1. 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.

  2. 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.

  3. Research approaches

    Emami E, de Grandmont P, Feine JS, Research approaches in prosthodontics., Eur J Prosthodont Restor Dent, 2008, 16, 4, 185-189.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Additional files

Editorial Notes