Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00933491
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

Dental implants are regarded as a standard of care in restoring missing teeth. Although there is a high prevalence of diabetics who receive dental implants, the relationship between dental implants and diabetes has not clearly been investigated.

A total of 32 subjects (14 patients with type II diabetes and 18 non-diabetes subjects) who have dental implants were recruited. The purposes of this research study were: (1) to evaluate diabetes patients to determine risk factors for bone loss at dental implants and teeth; and (2) to evaluate bone-resorptive biomarkers (proteins related to bone loss) present in saliva and blood serum, comparing the two groups.

Condition or Disease	Intervention/Treatment	Phase
Diabetes

Detailed Description

OBJECTIVE:

Regulators of peri-implant bone loss in patients with diabetes appear to involve multiple risk factors that have not been clearly elucidated. This study was conducted to explore putative local etiologic factors on implant bone loss in relation to type 2 diabetes mellitus, including clinical, microbial, salivary biomarker, and psychosocial factors.

MATERIALS AND METHODS:

Thirty-two subjects (divided into type 2 diabetes mellitus and non-diabetic controls), having at least one functional implant and six teeth, were enrolled in a 1-year longitudinal investigation. Analyses of clinical measurements and standardized intra-oral radiographs, saliva and serum biomarkers (via protein arrays for 20 selected markers), and plaque biofilm (via qPCR for eight periodontal pathogens) were performed at baseline and 1 year. In addition, the subjects were asked to respond to questionnaires to assess behavioral and psychosocial variables.

Study Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus: A Feasibility Cohort Study
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Diabetic Type II Diabetes
Control Non-diabetics

Outcome Measures

Primary Outcome Measures

1. Radiographic Bone Level [12 months]

   Mean radiographic bone level at 12 months

2. Radiographic Bone Level [Baseline]

   Mean radiographic bone level at baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• be at least 40 years old

• have at least one dental implant that has been in function for at least 6 months

• have at least 6 natural teeth

• have good general oral health

• not be pregnant or breastfeeding or planning to become pregnant within the next year

• if you are a pre-menopausal woman you or your male partner must be surgically sterile or you must be using reliable birth control (i.e., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) now and throughout the study or abstain from sex throughout the study

Exclusion Criteria:

• not have an active oral infection, including periodontitis and rampant caries

• not have a history of chronic systemic illness or infection, history of oral cancer, life expectancy of less than 5 years

• not have had cancer treatment in the last 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michigan Center for Oral Health Research	Ann Arbor	Michigan	United States	48106

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Tae-Ju Oh, DDS, MS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Michigan Clinical Research Database homepage

Publications

None provided.

• Responsible Party: Tae-Ju Oh, Clinical Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT00933491
• Other Study ID Numbers: 2008-03
• First Posted: Jul 7, 2009
• Last Update Posted: Nov 4, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Tae-Ju Oh, Clinical Professor, University of Michigan: healthy
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

Participant Flow

Arm/Group Title	Diabetic	Control
Arm/Group Description	Type II Diabetes	Non-diabetics
Period Title: Overall Study
STARTED	14	18
COMPLETED	14	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Diabetic	Control	Total
Arm/Group Description	Type II Diabetes	Non-diabetics	Total of all reporting groups
Overall Participants	14	18	32
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	18 100%	32 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	65	64	64.5
Sex: Female, Male (Count of Participants)
Female	7 50%	9 50%	16 50%
Male	7 50%	9 50%	16 50%
Region of Enrollment (participants) [Number]
United States	14 100%	18 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Radiographic Bone Level
Description	Mean radiographic bone level at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic	Control
Arm/Group Description	Type II Diabetes	Non-diabetics
Measure Participants	14	18
Mean (Standard Deviation) [mm]	2.69 (.17)	2.54 (.15)

2. Primary Outcome

Title	Radiographic Bone Level
Description	Mean radiographic bone level at baseline
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic	Control
Arm/Group Description	Type II Diabetes	Non-diabetics
Measure Participants	14	18
Mean (Standard Deviation) [mm]	2.59 (.15)	2.71 (.14)

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	We monitored for adverse events from subject recruitment phase to completion of the study which took two years (2008-2010).
Arm/Group Title	Diabetic		Control
Arm/Group Description	Type II Diabetes		Non-diabetics
All Cause Mortality
	Diabetic		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Diabetic		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Diabetic		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.