Background and aim: Scaling and root planing (SRP) is the base of non-surgical therapies in the management of periodonitits, but low dose doxycycline is recognized to have therapeutic properties that can modulate host response. The aim of the present study was to compare some clinical parameters in patients with mild periodontitist treated by SRP with and without using doxycycline 20 mg.
Methods and materials: In this randomized double blind study, 44 patients with mild periododntitis were treated with standard SRP therapy and then randomly received either adjunctive 20 mg doxycycline or placebo for 3 months and twice daily. Inclusion criterion was: having at leat 14 untreated teeth with mild periodontitis in two quadrants that need comprehensive treatment.
Exclusion criteria were: pregnant women; patients with a history of tetracycline sensitivity; any sytemic infection requiring antibiotic prophylaxy for dental procedures; history of intake of tetracycline during the 3 last months; history of periodontal therapy (scaling and root planing or periodontal surgery) during the last 3 months. Before and after treatment clinical parameters including periodontal pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP) and modified gingival index (MGI) were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205058205N2
Registration date:2012-05-21, 1391/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-21, 1391/03/01
Registrant information
Name
Mohammad Reza Amjadi
Name of organization / entity
Deparment of periodontology, Esfahan faculty of dental sciences
Country
Iran (Islamic Republic of)
Phone
00983112279676-00983117922864
Email address
amjadi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of dentistry, Shahid Sadoghi University of Medical Sciences
Expected recruitment start date
2011-07-08, 1390/04/17
Expected recruitment end date
2011-11-23, 1390/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of doxycycline 20 mg as an adjunct to scaling and root planing in mild periodontitis patients
Public title
Clinical effects of subantimicrobial dose doxycycline
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: having at leat 14 untreated teeth with mild periodontitis in two quadrantsthat need comprehensive treatment.
Exclusion criteria were: pregnant women; patients with a history of tetracycline sensitivity; any sytemic infection requiring antibiotic prophylaxy for dental procedures; history of intake of tetracycline during the 3 last months; history of periodontal therapy (scaling and root planing or periodontal surgery) during the last 3 months.
Age
From 25 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoghi university
Street address
Faculty of dentistry of yazd university of medical sciences, Daheye fajr Boulevard, Emam Khomeyni street, Yazd
City
Yazd
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
424
Health conditions studied
1
Description of health condition studied
Clinical effects of subantimicrobial dose doxycycline
ICD-10 code
k08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
PPD: The distance between the gingival margin and depth of sulcus
Timepoint
Before treatment, 3 months after treatment
Method of measurement
Periodontal probe, mm
Secondary outcomes
1
Description
BOP: bleeding on probing
Timepoint
Before treatment, 3 months after treatment
Method of measurement
Periodontal probe,mm
2
Description
CAL: The distance between cementoenamel junction (CEJ) and the bottom of pocket
Timepoint
Before treatment, 3 months after treatment
Method of measurement
Periodontal probe,mm
3
Description
MGI: a gingival index for evaluation of gingival health
Timepoint
Before treatment, 3 months after treatment
Method of measurement
Periodontal probe,mm
Intervention groups
1
Description
Internention 2: control group: after scaling and root planing, patients used the placebo (containig starch) twice daily and for 3 months, orally.
Category
Treatment - Drugs
2
Description
Intervention 1: case group: After scaling and root planing, patients received capsules containing subantimicrobial dose doxycyline (2o mg) twice daily and for 3 months, orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoghi University of Medical Sciences, Faculty of dentistry