"Aim":The purpose of this study is to investigate the effect of non surgical periodontal therapy on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who have periodontitis.
"Materials and methods":A total of 24 type 2 DM patients with periodontitis will be selected for the study, and randomly divided into two equal groups, Plaque index (PI), bleeding on probing (BOP), probing depth (PD) and clinical attachment levels (CAL) were recorded. "Group 1": (12 patients) was treated with oral hygiene instruction, scaling and root planing, and doxycycline (100 mg/day for 15 days)." Group 2": (12 patients) has the same treatment but with placebo, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated hemoglobin (HbA1c) level, will be reevaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082417587N7
Registration date:2014-12-29, 1393/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-29, 1393/10/08
Registrant information
Name
Amirhossein Farahmand
Name of organization / entity
Dental Branch Islamic Azad University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2284 9604
Email address
perio-implant@hotmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-09-11, 1393/06/20
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of non-surgical periodontal therapy plus Doxycycline on HbA1c in patients with type 2 diabetes mellitus (DM).
Public title
A randomized double-blind placebo-controlled, clinical trial on the effect of non-surgical periodontal therapy plus doxycycline on HbA1c in patients with type 2 diabetes mellitus (DM).
Purpose
Treatment
Inclusion/Exclusion criteria
"Inclusion criteria": patients with diabetes mellitus type II (at least 3 months before diagnosis, and A fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis, minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, had an glycated α hemoglobin (HbA1c) value between 7- 9 percent at screening, had reported no changes in diabetes medications within the last 3 months, were in the care of a physician for their diabetes.
"Exclusion criteria": pregnancy or lactation, history of allergy to drugs used in the study; smoking; diabetes related emergency within 30 days ago; use of nonsteroidal anti-inflammatory drugs; or taking low dose daily aspirin (75-325 mg); use of immunosuppressive medications; antibiotic use; dialysis; risk of bleeding complications; the type of disease periodontal (Aggressive); a history of periodontal treatment in the previous 6 months; orthodontic treatment; using the removal prostheses; extensive dental caries; dental abscesses or infections.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the patients were randomly (Balanced Block Randomization) equal divided into two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dental Branch, Islamic Azad University of Tehran
Street address
No 4, 10th Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
19585/175
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
515
Health conditions studied
1
Description of health condition studied
periodontitis
ICD-10 code
K05.3
ICD-10 code description
Periodontitis
Primary outcomes
1
Description
Periodontal pocket
Timepoint
15 days
Method of measurement
Periodontal probe
Secondary outcomes
1
Description
glycated hemoglobin (HbA1c)
Timepoint
3 months
Method of measurement
Blood test
Intervention groups
1
Description
"Intervention group": Doxycycline 100 mg was manufactured by Razak Pharmaceutical Laboratory,Tehran- Iran .
Category
Treatment - Drugs
2
Description
"Control group":Placebo of was prepared in the same manner but without the active drug in it (Made by the Faculty of Pharmaceutical Sciences, Islamic Azad University of Tehran)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Branch Islamic Azad University of Tehran
Full name of responsible person
Amirhossein Farahmand
Street address
No4, 10th Neyestan, Pasdarn Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Council of Dental Branch Islamic Azad University of Tehran
Full name of responsible person
Amirhossein Farahmand
Street address
No 4, 10th Neyestan Alley, Pasdaran Ave, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Council of Dental Branch Islamic Azad University of Tehran