NCT03727620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

October 10, 2018

Last Update Submit

October 31, 2018

Conditions

Aggressive Periodontitis

Keywords

aggressive periodontitissystemic antibioticsdoxycycline

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • Plaque index decrease

    3 months

  • Gingival index decrease

    3 months

Study Arms (2)

doxycycline group

EXPERIMENTAL

Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days

Drug: Doxycycline

amoxicillin plus metronidazole group

ACTIVE COMPARATOR

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

Interventions

amoxicillin plus metronidazoleDRUG

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
amoxicillin plus metronidazole group
DoxycyclineDRUG

patients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days

Also known as: Longamycine
doxycycline group

Eligibility Criteria

Age16 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy,
  • lactation,
  • and smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BENRACHADI Latifa

Rabat, Morocco

Location

Related Publications (3)

  • 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.

    PMID: 12787214BACKGROUND

  • 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.

    PMID: 25139116BACKGROUND

  • 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.

    PMID: 16553634BACKGROUND

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

AmoxicillinMetronidazoleDoxycycline

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Latifa BENRACHADI, Professor

    Faculty of medicine dentistery, Mohammed V University of Rabat

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2018

First Posted

November 1, 2018

Study Start

January 6, 2014

Primary Completion

June 6, 2014

Study Completion

December 8, 2014

Last Updated

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)