Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis.
BACKGROUND
Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment results in a modest reduction in glycosylated hemoglobin (Hb) A1c.


OBJECTIVE
The purpose of the Diabetes and Periodontal Therapy Trial (DPTT) was to determine if periodontal treatment reduces HbA1c in patients with T2DM and periodontitis.


METHODS
DPTT was a phase-III, single-masked, multi-center, randomized trial with a planned enrollment of 600 participants. Participants were randomly assigned to receive periodontal treatment immediately (Treatment Group) or after 6 months (Control Group). HbA1c values and clinical periodontal measures were determined at baseline and 3 and 6 months following randomization. Medication usage and dosing were assessed at each visit. Periodontal treatment consisted of scaling and root planing for a minimum of two 90-minute sessions, plus the use of an antibacterial mouth rinse for at least 32 days afterwards. The primary outcome was change in HbA1c from baseline to 6 months and the trial was powered to detect a between-group difference of 0.6%. Secondary outcomes included changes in periodontal clinical measures, fasting plasma glucose, the Homeostasis Model Assessment (HOMA2) and the need for rescue diabetes or periodontal therapy.


CONCLUSIONS
Dental and medical researchers collaborated to recruit, treat and monitor participants with two chronic diseases to determine if treatment of one condition affects the status of the other.
(a)New York University, College of Dentistry, New York, New York 10010, United States.
S
S
Engebretson
M
M
Gelato
L
L
Hyman
B S
BS
Michalowicz
E
E
Schoenfeld
D001786:Blood Glucose / Q000032:analysis; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D009067:Mouthwashes / Q000627:therapeutic use; D010518:Periodontitis / Q000097:blood / Q000209:etiology / Q000628:therapy*; D012720:Severity of Illness Index; D016037:Single-Blind Method
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D009067:Mouthwashes; C517652:hemoglobin A1c protein, human
Diabetes mellitus; Glycosylated hemoglobin; HbA1c; Periodontal disease; Periodontitis; Type 2