Doxycycline in the Treatment of Aggressive Periodontitis
Primary Purpose
Aggressive Periodontitis
Status
Completed
Phase
Phase 1
Locations
Morocco
Study Type
Interventional
Intervention
amoxicillin plus metronidazole
Doxycycline
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive Periodontitis focused on measuring aggressive periodontitis, systemic antibiotics, doxycycline
Eligibility Criteria
Inclusion Criteria:
- subjects in good general health,
- presence of at least 20 teeth,
- no periodontal treatment performed during the previous 12 months,
- absence of antibiotic intake during six months before the study,
- and no known allergies to antibiotics used in the study
Exclusion Criteria:
- pregnancy,
- lactation,
- and smoking.
Sites / Locations
- BENRACHADI Latifa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
doxycycline group
amoxicillin plus metronidazole group
Arm Description
Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days
Drug Dispamox 500 mg, 3 times a day for 7 days Flagyl 250 mg, 3 times a day for 7 days
Outcomes
Primary Outcome Measures
Decrease of periodontal pockets ≥ 4mm
• Probing pockets depths were assessed to the nearest millimeter using a standard periodontal probe, when recruiting patient at baseline and the re-evaluation 3 months after nonsurgical mechanical debridement.
Secondary Outcome Measures
Plaque index decrease
Plaque index was assessed by using Loe and silness scores at baseline and the re-evaluation 3 months after nonsurgical mechanical debridement
Gingival index decrease
Gingival index was assessed by using Loe and silness scores at baseline and and at the re-evaluation 3 months after nonsurgical mechanical debridement
Full Information
NCT ID
NCT03727620
First Posted
October 10, 2018
Last Updated
October 31, 2018
Sponsor
Mohammed V Souissi University
1. Study Identification
Unique Protocol Identification Number
NCT03727620
Brief Title
Doxycycline in the Treatment of Aggressive Periodontitis
Official Title
Clinical Effects of Doxycycline in the Treatment of Aggressive Periodontitis: Comparative Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 6, 2014 (Actual)
Primary Completion Date
June 6, 2014 (Actual)
Study Completion Date
December 8, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mohammed V Souissi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study was to compare the clinical effects of systemic use of doxycycline to amoxicillin plus metronidazole as adjunctive treatment in nonsurgical debridement of aggressive periodontitis (AgP). Twenty four patients with aggressive periodontitis were enrolled in this clinical study. They all received oral hygiene instruction and full-mouth nonsurgical debridement using manual instruments. The test group received as adjunctive antibiotic treatment 200 mg of doxycycline the first day followed by 100 mg per day during 14 days. The control group received 500 of amoxicillin and 250 of metronidazole, three times a day for 7 days.
Detailed Description
This comparative clinical study was conducted in the department of Periodontology, Center for Dental Consultation and Treatment (CDCT), Rabat, Morocco.
Prior to participation, the purpose of the investigation was fully explained to all participants and written informed consent was obtained from all patients. The study protocol was approved by the biomedical ethical committee of University Mohammed V in Rabat, Morocco, and conducted according to the principles outlined in the Declaration of Helsinki on experimentation involving human subjects.
Patients : Twenty four subjects diagnosed with localized (LAgP) or generalized aggressive periodontitis (GAgP) (8 patients with LAgP and 16 with GAgP) were enrolled in the study. Patients were aged between 16 and 26 years and were from both genders (22 female and 2 male).The diagnosis was based on the classification of the American Academy of Periodontology (AAP).
Clinical variables were pocket depth, plaque index, gingival index
At the end of the debridement sessions, patients were assigned doxycycline or the amoxicillin plus metronidazole regardless the type of AgP. So that, experimental group of patients were administered 200 mg of doxycycline the first day followed by 100 mg per day for 14 days, and the control group were administered 250 mg of metronidazole and 500 mg of amoxicillin, three times a day for 7 days.
Data analysis The data were analyzed using the patient as a unit (subject based analysis). The statistical analysis was performed with a statistical program (SPSS Inc., Chicago, IL, USA). The improvement of periodontal status was evaluated by calculating, for each patient, the difference in Plaque Index (DIP), gingival index (DIG) and probing depth (DPD) ≥ 4mm, between baseline and 3 months post treatment. For each patient, the quantitative variables (PI, GI, and MPD) were expressed as medians and quartiles and were compared before and after treatment using the Wilcoxon test. Improved plaque index (DIP), gingival index (DIG), and probing depth (DPD ≥ 4mm) was compared between the two groups (doxycycline and amoxicillin plus metronidazole) using the Mann-Whitney test. A level P<0,05 was accepted for statistical significance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis
Keywords
aggressive periodontitis, systemic antibiotics, doxycycline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
doxycycline group
Arm Type
Experimental
Arm Description
Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days
Arm Title
amoxicillin plus metronidazole group
Arm Type
Active Comparator
Arm Description
Drug Dispamox 500 mg, 3 times a day for 7 days Flagyl 250 mg, 3 times a day for 7 days
Intervention Type
Drug
Intervention Name(s)
amoxicillin plus metronidazole
Other Intervention Name(s)
Dispamox and Flagyl
Intervention Description
patients were administered 250 mg of Flagyl and 500 mg of Dyspamox, three times a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Longamycine
Intervention Description
patients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days
Primary Outcome Measure Information:
Title
Decrease of periodontal pockets ≥ 4mm
Description
• Probing pockets depths were assessed to the nearest millimeter using a standard periodontal probe, when recruiting patient at baseline and the re-evaluation 3 months after nonsurgical mechanical debridement.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plaque index decrease
Description
Plaque index was assessed by using Loe and silness scores at baseline and the re-evaluation 3 months after nonsurgical mechanical debridement
Time Frame
3 months
Title
Gingival index decrease
Description
Gingival index was assessed by using Loe and silness scores at baseline and and at the re-evaluation 3 months after nonsurgical mechanical debridement
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subjects in good general health,
presence of at least 20 teeth,
no periodontal treatment performed during the previous 12 months,
absence of antibiotic intake during six months before the study,
and no known allergies to antibiotics used in the study
Exclusion Criteria:
pregnancy,
lactation,
and smoking.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Latifa BENRACHADI, Professor
Organizational Affiliation
Faculty of medicine dentistery, Mohammed V University of Rabat
Official's Role
Principal Investigator
Facility Information:
Facility Name
BENRACHADI Latifa
City
Rabat
Country
Morocco
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12787214
Citation
Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.8.x.
Results Reference
background
PubMed Identifier
25139116
Citation
Guerrero A, Nibali L, Lambertenghi R, Ready D, Suvan J, Griffiths GS, Wilson M, Tonetti MS. Impact of baseline microbiological status on clinical outcomes in generalized aggressive periodontitis patients treated with or without adjunctive amoxicillin and metronidazole: an exploratory analysis from a randomized controlled clinical trial. J Clin Periodontol. 2014 Nov;41(11):1080-9. doi: 10.1111/jcpe.12299. Epub 2014 Sep 11.
Results Reference
background
PubMed Identifier
16553634
Citation
Xajigeorgiou C, Sakellari D, Slini T, Baka A, Konstantinidis A. Clinical and microbiological effects of different antimicrobials on generalized aggressive periodontitis. J Clin Periodontol. 2006 Apr;33(4):254-64. doi: 10.1111/j.1600-051X.2006.00905.x.
Results Reference
background
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Doxycycline in the Treatment of Aggressive Periodontitis
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