Periodontal DiseasesPhase 1/2NCT06199440
Azithromycin Versus Doxycycline on Restistin Level in Periodontitis Patients With Type 2 Diabetes
A Phase 1/2 study testing Group I, Group II and Group III in people with Periodontal Diseases and Type 2 Diabetes, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The aim of this study is to evaluate the adjunctive effects of systemic antibiotics used in nonsurgical periodontal treatment (NSPT), compared with NSPT alone, on the periodontal clinical parameters and resistin level in diabetic patients with periodontitis, in order to identify which, one provides an additional… Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Periodontal Diseases, Type 2 Diabetes
- What is being tested?
- Group I, Group II and Group III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2022to 30 Mar 2023
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were clinically diagnosed as having at least three site with CAL ≥ 5mm; moderate to advanced chronic periodontitis according to the criteria of American Academy of Periodontology.
- Free from any other systemic conditions that affect the periodontium except for Diabetes mellitus type II.
- No periodontal therapy, systemic antibiotics or non-steroidal anti-inflammatory agents during the preceding 6 months.
- Non-smokers.
- Non-pregnant.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azithromycin Versus Doxycycline on Resistin Level in Periodontitis Patients With Type 2 Diabetes. A Randomized Controlled Clinical Trial
The aim of this study is to evaluate the adjunctive effects of systemic antibiotics used in nonsurgical periodontal treatment (NSPT), compared with NSPT alone, on the periodontal clinical parameters and resistin level in diabetic patients with periodontitis, in order to identify which, one provides an additional effect to non-surgical periodontal therapy
- Conditions
- Periodontal Diseases, Type 2 Diabetes
- Being tested
- Group I, Group II, Group III
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group IDrug
First group are chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.
Group IIDrug
Second group will receive 250 mg of azithromycin per day for a period of 5 days, after an initial dose of 500 mg one hour before NSPT.
Group IIIDrug
Third group are Type 2 DM patients who received doxycycline 20mg twice/day.
Gingival crevicular fluid will be collected at 0, 1, and 3 months to assess Serum Resistin using a human Resistin enzyme-linked immunosorbent assay Kit following the manufacturer's protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning. Receives: Drug: Group I |
| Group II | Experimental | Received azithromycin dosage is 250 mg/day for 5 days, after an initial dose of 500 mg one hour before NSPT Receives: Drug: Group II |
| Group III | Experimental | Consisted of 5 type 2 Diabetes Mellitus patients with periodontitis who were received doxycycline 20mg twice/day. Receives: Drug: Group III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Improvements in clinical parameters of periodontitis including Gingival Index, Probing Depth and Clinical Attachment Level
Measured: 3 months
Secondary outcomes (1)
Secondary Outcome
Improved resistin level
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 posted10 Jan 2024
- Study start1 Jun 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jazia Alblowi, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199440
- Sponsor's protocol ID
- 121-06-23
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Versus Doxycycline on Resistin Level in Periodontitis Patients With Type 2 Diabetes. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06199440
- Acronym / sponsor ID
- 121-06-23
- Conditions
- Periodontal Diseases, Type 2 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 10 Jan 2024 (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 this study is to evaluate the adjunctive effects of systemic antibiotics used in nonsurgical periodontal treatment (NSPT), compared with NSPT alone, on the periodontal clinical parameters and resistin level in diabetic patients with periodontitis, in order to identify which, one provides an additional effect to non-surgical periodontal therapy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Group IChronic periodontitis patients with diabetes mellitus type II who received scaling and root planning. |
| Group II | Experimental | Drug: Group IIReceived azithromycin dosage is 250 mg/day for 5 days, after an initial dose of 500 mg one hour before NSPT |
| Group III | Experimental | Drug: Group IIIConsisted of 5 type 2 Diabetes Mellitus patients with periodontitis who were received doxycycline 20mg twice/day. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients were clinically diagnosed as having at least three site with CAL ≥ 5mm; moderate to advanced chronic periodontitis according to the criteria of American Academy of Periodontology.
- Free from any other systemic conditions that affect the periodontium except for Diabetes mellitus type II.
- No periodontal therapy, systemic antibiotics or non-steroidal anti-inflammatory agents during the preceding 6 months.
- Non-smokers.
- Non-pregnant.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Group IFirst group are chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning. | Drug | Group I |
| Group IISecond group will receive 250 mg of azithromycin per day for a period of 5 days, after an initial dose of 500 mg one hour before NSPT. | Drug | Group II |
| Group IIIThird group are Type 2 DM patients who received doxycycline 20mg twice/day. Gingival crevicular fluid will be collected at 0, 1, and 3 months to assess Serum Resistin using a human Resistin enzyme-linked immunosorbent assay Kit following the manufacturer's protocol. | Drug | Group III |
Primary outcome
Primary Outcome
Time frame: 3 months
Improvements in clinical parameters of periodontitis including Gingival Index, Probing Depth and Clinical Attachment Level
1 secondary outcome
Secondary Outcome
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 10 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Group I, Group II and Group III in people with Periodontal Diseases and Type 2 Diabetes, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 1 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 10 Jan 2024. 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 Saudi Arabia. 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?
Primary Outcome (time frame: 3 months). 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 10 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.