A Phase 1/2 interventional study of amoxicillin plus metronidazole and Doxycycline in Aggressive Periodontitis, sponsored by Mohammed V Souissi University. Completed at 1 site in Morocco. Open to participants aged 16 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-01.
Sponsored by Mohammed V Souissi University · Phase 1/2, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 24 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Mohammed V Souissi University is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days
Drug: Doxycycline
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
Also known as: Dispamox and Flagyl
patients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days
Also known as: Longamycine
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.
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Mohammed V Souissi University