Clinical Trials Directory

Trials / Completed

CompletedNCT03727620

Doxycycline in the Treatment of Aggressive Periodontitis

Clinical Effects of Doxycycline in the Treatment of Aggressive Periodontitis: Comparative Clinical Study

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Mohammed V Souissi University · Academic / Other
Sex
All
Age
16 Years – 36 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGamoxicillin plus metronidazolepatients were administered 250 mg of Flagyl and 500 mg of Dyspamox, three times a day for 7 days
DRUGDoxycyclinepatients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days

Timeline

Start date
2014-01-06
Primary completion
2014-06-06
Completion
2014-12-08
First posted
2018-11-01
Last updated
2018-11-01

Locations

1 site across 1 country: Morocco

Source: ClinicalTrials.gov record NCT03727620. Inclusion in this directory is not an endorsement.