Chronic Periodontitis, GeneralizedPhase 4NCT03783845
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients
A Phase 4 study testing amoxicillin 500mg and metronidazole 400mg in people with Chronic Periodontitis, Generalized, run by Taibah University.
Trial summary
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis? Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Periodontitis, Generalized
- What is being tested?
- amoxicillin 500mg and metronidazole 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 30 Mar 2016
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis
Who cannot join
- Pregnancy
- Alcoholism and smoking
- Presence of any systemic disorders other than hypertension and diabetes
- Diabetic major complications
About this study
Official title: The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?
Read the detailed description
The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes.
Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group
- Conditions
- Chronic Periodontitis, Generalized
- Being tested
- amoxicillin 500mg and metronidazole 400mg
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin 500mg and metronidazole 400mgCombination product
Also called Amoxil and Flagyl
metronidazole 400mg and amoxicillin 500mg three times daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Metronidazole 400mg,three times daily for two weeks
Amoxicillin 500mg,three times daily for two weeks. Receives: Combination Product: amoxicillin 500mg and metronidazole 400mg |
| control group | No intervention | no intervention during study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated haemoglobin (HbA1c)
Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography
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 posted21 Dec 2018
- Study start1 Jun 2015
- Primary completion1 Mar 2016
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Periodontitis, GeneralizedStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser El Makaky, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783845
- Sponsor's protocol ID
- periodontal therapy and HbA1c
- Status last verified
- Oct 2019
- First submitted
- 19 Dec 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03783845
- Acronym / sponsor ID
- periodontal therapy and HbA1c
- Conditions
- Chronic Periodontitis, Generalized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 21 Dec 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.
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?
Detailed description
The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes.
Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Combination Product: amoxicillin 500mg and metronidazole 400mgMetronidazole 400mg,three times daily for two weeks Amoxicillin 500mg,three times daily for two weeks. |
| control group | No intervention | –no intervention during study period |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis
Key exclusion criteria (4 listed)
- Pregnancy
- Alcoholism and smoking
- Presence of any systemic disorders other than hypertension and diabetes
- Diabetic major complications
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 500mg and metronidazole 400mgAlso: Amoxil and Flagylmetronidazole 400mg and amoxicillin 500mg three times daily for two weeks | Combination product | test group |
Primary outcome
glycosylated haemoglobin (HbA1c)
Time frame: 3 months
Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography
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 21 Oct 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin 500mg and metronidazole 400mg in people with Chronic Periodontitis, Generalized, run by Taibah University.
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 1 inclusion and 4 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
glycosylated haemoglobin (HbA1c) (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 21 Oct 2019.