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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
Sponsor:
Information provided by (Responsible Party):
BENRACHADI Latifa, Mohammed V Souissi University

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.

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Drug: amoxicillin plus metronidazole Drug: Doxycycline Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: doxycycline group
Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days
Drug: Doxycycline
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   16 Years to 36 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Morocco
BENRACHADI Latifa
Rabat, Morocco
Sponsors and Collaborators
Mohammed V Souissi University
Investigators
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Principal Investigator: Latifa BENRACHADI, Professor Faculty of medicine dentistery, Mohammed V University of Rabat

Publications:
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Responsible Party: BENRACHADI Latifa, Professor, Mohammed V Souissi University
ClinicalTrials.gov Identifier: NCT03727620     History of Changes
Other Study ID Numbers: DOXYAPG18
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BENRACHADI Latifa, Mohammed V Souissi University:
aggressive periodontitis
systemic antibiotics
doxycycline
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Amoxicillin
Metronidazole
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials