Trial Outcomes & Findings for Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population (NCT NCT01798225)

NCT ID: NCT01798225

Last Updated: 2018-10-04

Results Overview

Glycated Hemoglobin A1c

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 113 participants
• Primary outcome timeframe: Change between baseline to 6-month post-treatment
• Results posted on: 2018-10-04

Participant Flow

Recruitment period from 12/18/2007 to 01/12/2010. Recruitment happened from previous studies and community events.

Participant milestones

Measure	Control Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills. Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.	Doxycycline Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills) Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)
Overall Study STARTED	57	56
Overall Study COMPLETED	57	53
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population

Baseline characteristics by cohort

Measure	Control n=57 Participants Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills. Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.	Doxycycline n=56 Participants Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills) Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)	Total n=113 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	38 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	56 participants n=7 Participants	113 participants n=5 Participants

PRIMARY outcome

Timeframe: Change between baseline to 6-month post-treatment

Glycated Hemoglobin A1c

Outcome measures

Measure	Control n=57 Participants Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills. Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.	Doxycycline n=56 Participants Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills) Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)
Glycated Hemoglobin A1c	8 percentage of Glycated Hemoglobin A1c Interval 5.3 to 12.8	8.2 percentage of Glycated Hemoglobin A1c Interval 4.7 to 14.1

PRIMARY outcome

Timeframe: Change between baseline to 6-month post-treatment

Outcome measures

Measure	Control n=57 Participants Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills. Placebo: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.	Doxycycline n=56 Participants Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills) Doxycycline: Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)
Periodontal Pocket Probing Depth (PD)	-1.98 mm Standard Error 0.0001	-1.37 mm Standard Error 0.0001

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Doxycycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Renata Leite

Medical University of South Carolina

Phone: 843-792-3908

Email: leiter@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place