Aggressive PeriodontitisPhase 1/2NCT03727620
Doxycycline in the Treatment of Aggressive Periodontitis
A Phase 1/2 study testing amoxicillin plus metronidazole and Doxycycline in people with Aggressive Periodontitis, run by Mohammed V Souissi University at 1 site in Morocco.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggressive Periodontitis
- What is being tested?
- amoxicillin plus metronidazole and Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMorocco
- Study dates
- 6 Jan 2014to 8 Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 36 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- pregnancy,
- lactation,
- and smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effects of Doxycycline in the Treatment of Aggressive Periodontitis: Comparative Clinical Study
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.
Read the 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
- Aggressive Periodontitis
- Being tested
- amoxicillin plus metronidazole, Doxycycline
- Keywords
- aggressive periodontitis, systemic antibiotics, doxycycline
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin plus metronidazoleDrug
Also called Dispamox and Flagyl
patients were administered 250 mg of Flagyl and 500 mg of Dyspamox, three times a day for 7 days
DoxycyclineDrug
Also called Longamycine
patients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| doxycycline group | Experimental | Drug Longamycine 200 mg the first day , then 100 mg per day for 14 days Receives: 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 Receives: Drug: amoxicillin plus metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start6 Jan 2014
- Primary completion6 Jun 2014
- Study completion8 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aggressive PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed V Souissi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BENRACHADI Latifa, Mohammed V Souissi University
- Investigators
- Latifa BENRACHADI, Professor, Principal investigator, Faculty of medicine dentistery, Mohammed V University of Rabat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727620
- Sponsor's protocol ID
- DOXYAPG18
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12787214Guerrero 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.
PubMed 25139116Xajigeorgiou 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.
PubMed 16553634
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Doxycycline in the Treatment of Aggressive Periodontitis: Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT03727620
- Acronym / sponsor ID
- DOXYAPG18
- Conditions
- Aggressive Periodontitis
- Keywords
- aggressive periodontitis, systemic antibiotics, doxycycline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mohammed V Souissi UniversityUniversity, hospital or other
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- 6 Jun 2014 (actual)
- Study completion
- 8 Dec 2014 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxycycline group | Experimental | Drug: DoxycyclineDrug Longamycine 200 mg the first day , then 100 mg per day for 14 days |
| amoxicillin plus metronidazole group | Active comparator | Drug: amoxicillin plus metronidazoleDrug Dispamox 500 mg, 3 times a day for 7 days Flagyl 250 mg, 3 times a day for 7 days |
Who may qualify
- Ages
- 16 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy,
- lactation,
- and smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amoxicillin plus metronidazoleAlso: Dispamox and Flagylpatients were administered 250 mg of Flagyl and 500 mg of Dyspamox, three times a day for 7 days | Drug | amoxicillin plus metronidazole group |
| DoxycyclineAlso: Longamycinepatients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days | Drug | doxycycline group |
Primary outcome
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.
2 secondary outcomes
Plaque index decrease
Time frame: 3 months
Gingival index decrease
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Background: PubMed 12787214Herrera 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.
- Background: PubMed 25139116Guerrero 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.
- Background: PubMed 16553634Xajigeorgiou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Latifa BENRACHADI, Professor principal investigator
Faculty of medicine dentistery, Mohammed V University of Rabat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing amoxicillin plus metronidazole and Doxycycline in people with Aggressive Periodontitis, run by Mohammed V Souissi University at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of periodontal pockets ≥ 4mm (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727620, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.