Chronic PeriodontitisPhase 2NCT01921738
The Effect of Azithromycin in the Treatment of Chronic Periodontitis
A Phase 2 study testing 1% Azithromycin gel and Azithromycin in people with Chronic Periodontitis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to investigate the effects of Azithromycin (systemic and locally) on the clinical and microbiological parameters of periodontal in patients with chronic periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- 1% Azithromycin gel and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Apr 2013
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate to severe chronic periodontitis
- At least twenty teeth
- Age over 18 years
Who cannot join
- With Systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system
- History of antibiotic therapy within the 4 months prior to study
- History of Allergy to the macrolide group of antibiotics
- Smoking
- The lack of patient cooperation
- History of periodontal treatment during the 4 months prior to the trial
Show all 9Show fewer
- Pregnancy
- Lactating females
- Patients treated with drugs such as: Anti-acid, Warfarin and Cyclisporine 10) Alcohol use.
Trial locations and contacts
1 site in 1 country.
Iran1 site
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Isfahan, 81746-73461
About this study
Official title: The Effects of Systemic and Locally Azithromycin Adjunct to Scaling and Root Planning on Clinical and Microbiological Periodontal Indices in Moderate to Severe Chronic Periodontitis
The aim of this study is to investigate the effects of Azithromycin (systemic and locally) on the clinical and microbiological parameters of periodontal in patients with chronic periodontitis.
Read the detailed description
The double-blind, placebo-controlled clinical trial that is carried out in eighty patients who referred to the Department of Periodontology, Isfahan School of Dentistry. Main inclusion criteria were: 1) Patients with moderate to severe chronic periodontitis 2) At least twenty teeth 3) Age over 18 years. Main exclusion criteria were: 1) History of allergy to the macrolide group 2) History of antibiotic therapy within the 4 months ago 3) The lack of patient cooperation. For all patients is initially performed scaling and root planning (SRP). Oral health education is given to all patients. After one month, patients are randomly divided into four equal groups (two test groups and two control groups). Azithromycin(AZM) 250 milligram (mg) capsules, two times a day (bid), for three days will be given to a test group. In the other test group, 1% AZM gel is locally injected into the periodontal pockets in single-root teeth. Placebo capsules with the same dose and frequency will be given to a control group. In the other control group, placebo gel is injected in the same places. Clinical parameters included pocket depth (PD), clinical attachment level (CAL), papillary bleeding index (PBI), and periodontal disease index (PDI), which are recorded at baseline (before SRP), at 1, 2, 3 and 4 months after treatment. Using polymerase chain reaction (PCR), microbiological assessment of the percentage of Porphyromonas gingivalis (P.g) and Actinobacillus actinomycetemcomitans (A.a) are randomly done for 40 patients (10 patients from each group) at baseline and at 3 months after the treatment.
- Conditions
- Chronic Periodontitis
- Being tested
- 1% Azithromycin gel, Azithromycin, placebo gel, placebo capsule
- Keywords
- Chronic Periodontitis, Azithromycin, SRP
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Azithromycin gelDrug
Also called Avindo Gel (Azithromycin Gel 1%), serial number: 8904069410010
Participants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes.
AzithromycinDrug
Also called Zithromax (Zimexir, Exir, Brojerd, Iran), serial number: 6260153032097
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)
placebo gelDrug
Also called carbopol 934P/974P
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.
placebo capsuleDrug
Also called sugar capsule
Participants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days.
| Study group | Role | What they receive |
|---|---|---|
| 1% Azithromycin gel | Experimental | Participants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes. Receives: Drug: 1% Azithromycin gel |
| Azithromycin capsule | Experimental | Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules) Receives: Drug: Azithromycin |
| Placebo Gel | Placebo comparator | Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel. Receives: Drug: placebo gel |
| placebo capsule | Placebo comparator | Participants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days. Receives: Drug: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Periodontal Pocket Depth
measurement was done with color coded periodontal probe (Nordent).
Measured: at one, two, three and four months after the intervention.
Change from baseline in Clinical Attachment Level
measurement was done with color coded periodontal probe (Nordent).
Measured: at one, two, three and four months after the intervention.
Change from baseline in Modified Gingival Index
visual scale, according to Lobene classification.
Measured: at one, two, three and four months after the intervention.
Change from baseline in Papillary Bleeding Index
measurement was done with color coded periodontal probe (Nordent), according to (Muhlemann and Saxer) classification.
Measured: at one, two, three and four months after the intervention.
Change from baseline in Porphyromonas gingivalis count
measurement was done with Real Time PCR (Primer Design kits).
Measured: at three months after the intervention
Change from baseline in Actinobacillus actinomycetemcomitans count
measurement was done with Real Time PCR (Primer Design kits).
Measured: at three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahsa Maksabi, Isfahan University of Medical Sciences
- Investigators
- Mahsa Maksabi, D.D.S, Principal investigator, Department of Periodontology, Isfahan School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921738
- Sponsor's protocol ID
- mnts-o77
- Status last verified
- Aug 2013
- First submitted
- 8 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Systemic and Locally Azithromycin Adjunct to Scaling and Root Planning on Clinical and Microbiological Periodontal Indices in Moderate to Severe Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT01921738
- Acronym / sponsor ID
- mnts-o77
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic Periodontitis, Azithromycin, SRP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Aug 2013 (estimated)
- 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 this study is to investigate the effects of Azithromycin (systemic and locally) on the clinical and microbiological parameters of periodontal in patients with chronic periodontitis.
Detailed description
The double-blind, placebo-controlled clinical trial that is carried out in eighty patients who referred to the Department of Periodontology, Isfahan School of Dentistry. Main inclusion criteria were: 1) Patients with moderate to severe chronic periodontitis 2) At least twenty teeth 3) Age over 18 years. Main exclusion criteria were: 1) History of allergy to the macrolide group 2) History of antibiotic therapy within the 4 months ago 3) The lack of patient cooperation. For all patients is initially performed scaling and root planning (SRP). Oral health education is given to all patients. After one month, patients are randomly divided into four equal groups (two test groups and two control groups). Azithromycin(AZM) 250 milligram (mg) capsules, two times a day (bid), for three days will be given to a test group. In the other test group, 1% AZM gel is locally injected into the periodontal pockets in single-root teeth. Placebo capsules with the same dose and frequency will be given to a control group. In the other control group, placebo gel is injected in the same places. Clinical parameters included pocket depth (PD), clinical attachment level (CAL), papillary bleeding index (PBI), and periodontal disease index (PDI), which are recorded at baseline (before SRP), at 1, 2, 3 and 4 months after treatment. Using polymerase chain reaction (PCR), microbiological assessment of the percentage of Porphyromonas gingivalis (P.g) and Actinobacillus actinomycetemcomitans (A.a) are randomly done for 40 patients (10 patients from each group) at baseline and at 3 months after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1% Azithromycin gel | Experimental | Drug: 1% Azithromycin gelParticipants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes. |
| Azithromycin capsule | Experimental | Drug: AzithromycinParticipants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules) |
| Placebo Gel | Placebo comparator | Drug: placebo gelParticipants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel. |
| placebo capsule | Placebo comparator | Drug: placebo capsuleParticipants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with moderate to severe chronic periodontitis
- At least twenty teeth
- Age over 18 years
Key exclusion criteria (9 listed)
- With Systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system
- History of antibiotic therapy within the 4 months prior to study
- History of Allergy to the macrolide group of antibiotics
- Smoking
- The lack of patient cooperation
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 |
|---|---|---|
| 1% Azithromycin gelAlso: Avindo Gel (Azithromycin Gel 1%), serial number: 8904069410010Participants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes. | Drug | 1% Azithromycin gel |
| AzithromycinAlso: Zithromax (Zimexir, Exir, Brojerd, Iran), serial number: 6260153032097Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules) | Drug | Azithromycin capsule |
| placebo gelAlso: carbopol 934P/974PParticipants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel. | Drug | Placebo Gel |
| placebo capsuleAlso: sugar capsuleParticipants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days. | Drug | placebo capsule |
Primary outcome
Change from baseline in Periodontal Pocket Depth
Time frame: at one, two, three and four months after the intervention.
measurement was done with color coded periodontal probe (Nordent).
Change from baseline in Clinical Attachment Level
Time frame: at one, two, three and four months after the intervention.
measurement was done with color coded periodontal probe (Nordent).
Change from baseline in Modified Gingival Index
Time frame: at one, two, three and four months after the intervention.
visual scale, according to Lobene classification.
Change from baseline in Papillary Bleeding Index
Time frame: at one, two, three and four months after the intervention.
measurement was done with color coded periodontal probe (Nordent), according to (Muhlemann and Saxer) classification.
Change from baseline in Porphyromonas gingivalis count
Time frame: at three months after the intervention
measurement was done with Real Time PCR (Primer Design kits).
Change from baseline in Actinobacillus actinomycetemcomitans count
Time frame: at three months after the intervention
measurement was done with Real Time PCR (Primer Design kits).
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 13 Aug 2013.
- Iranian Registry of Clinical TrialsLink provided by the sponsor.
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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.
Mahsa Maksabi, D.D.S principal investigator
Department of Periodontology, Isfahan School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% Azithromycin gel and Azithromycin in people with Chronic Periodontitis, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 9 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 13 Aug 2013. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Change from baseline in Periodontal Pocket Depth (time frame: at one, two, three and four months after the intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2013.