Doxycycline in the Treatment of Aggressive Periodontitis
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|ClinicalTrials.gov Identifier: NCT03727620|
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aggressive Periodontitis||Drug: amoxicillin plus metronidazole Drug: Doxycycline||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Effects of Doxycycline in the Treatment of Aggressive Periodontitis: Comparative Clinical Study|
|Actual Study Start Date :||January 6, 2014|
|Actual Primary Completion Date :||June 6, 2014|
|Actual Study Completion Date :||December 8, 2014|
Experimental: doxycycline group
Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days
patients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days
Other Name: Longamycine
Active Comparator: amoxicillin plus metronidazole group
Drug Dispamox 500 mg, 3 times a day for 7 days Flagyl 250 mg, 3 times a day for 7 days
Drug: amoxicillin plus metronidazole
patients were administered 250 mg of Flagyl and 500 mg of Dyspamox, three times a day for 7 days
Other Name: Dispamox and Flagyl
- Decrease of periodontal pockets ≥ 4mm [ Time Frame: 3 months ]• 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.
- Plaque index decrease [ Time Frame: 3 months ]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 [ Time Frame: 3 months ]Gingival index was assessed by using Loe and silness scores at baseline and and at the re-evaluation 3 months after nonsurgical mechanical debridement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727620
|Principal Investigator:||Latifa BENRACHADI, Professor||Faculty of medicine dentistery, Mohammed V University of Rabat|