Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedOctober 19, 2016
October 1, 2016
2.3 years
July 11, 2015
October 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Serum levels glycosylated hemoglobin
Baseline and 6 months after intervention
Study Arms (2)
Treatment Group
EXPERIMENTALThe Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions
Control Group
ACTIVE COMPARATORThe Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions
Interventions
Full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France) and Gracey curretes (Hu- Friedy, Chicago, USA).
Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France)
Eligibility Criteria
You may qualify if:
- Diagnostic of T2DM (diagnosed at least 1'5 years prior the study).
- Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm).
You may not qualify if:
- Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months.
- Having received non-surgical periodontal treatment within the past 6 months.
- Pregnancy
- Significant change of medication for diabetes during the course of the study
- Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jose López-López, Phd
University of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dentistry
Study Record Dates
First Submitted
July 11, 2015
First Posted
January 11, 2016
Study Start
June 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 19, 2016
Record last verified: 2016-10