Diabetes MellitusNCT06463535
Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Diabetes: A Randomized Clinical Trial
A study testing Omega 3 and SRP alone in people with Diabetes Mellitus and Periodontal Diseases, run by British University In Egypt at 1 site in Egypt.
Trial summary
Patient grouping Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3) Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL). Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Periodontal Diseases
- What is being tested?
- Omega 3 and SRP alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients had type 2 DM for more than 2 years (diagnosed according to the American Diabetes Association criteria), with no other systemic problem. •Subjects had 14 or more natural teeth, of which at least five had a site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment level ≥ 3 mm. From this point, according to the American Academy of Periodontology, subjects with moderate to severe periodontitis were included
Who cannot join
- Pregnant and breastfeeding women, smokers or former smokers, patients with other autoimmune or systemic disease, those patients who took antibiotics in the last 6 months and patients weren't willing to follow our study protocol or plaque regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level
Patient grouping
- Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
- Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL). 6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.
Read the detailed description
A parallel design randomized clinical trial was performed involving thirty participants divided into two groups, 15 participants in each group selected from the outpatient clinic in Oral medicine and Periodontology department.
Diabetic control was assessed by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 m. HbA1c was assessed at baseline, 3m, and 6m.
Patient grouping
- Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
- Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) Periodontal treatment protocol
Group 1 and 2 patients were treated by non-surgical approach in following steps:
- Each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices.
- Full mouth SRP using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions.
- Chlorehexidine CHX mouthwash was prescribed for patients to be used twice daily.
- For each patient, follow up visits every 2 weeks were done to ensure plaque control.
- Patients were re- examined after 2 weeks (baseline), 3 and 6 months
- Conditions
- Diabetes Mellitus, Periodontal Diseases
- Being tested
- Omega 3, SRP alone
- Medical subject headings
- Diabetes Mellitus, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Drug
SRP + OMEGA 3
SRP aloneProcedure or surgery
Scaling and root planning
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3 Receives: Drug: Omega 3; Procedure: SRP alone |
| group II | Active comparator | Type 2 Diabetes Mellitus patients with CPD + SRP Receives: Procedure: SRP alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of chemerin
Serum level of chemerin
Measured: 6 months
Secondary outcomes (4)
periodontal clinical parameters
PD in mm
Measured: 6 months
hba1c
Glycated Heamoglobin
Measured: 6 months
GCF level of chemerin
GCF level of chemerin
Measured: 6 months
periodontal clinical parameters
CAL in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start15 Jun 2023
- Primary completion15 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El-Gawish, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463535
- Sponsor's protocol ID
- BU7720
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ghalwash D, Ammar A, Hamdy A, El-Gawish A. Impact of the Adjunctive Use of Omega-3 in Periodontitis Patients With Diabetes on Local and Systemic Chemerin Levels: A Randomized Clinical Trial. Int J Dent. 2025 Jul 30;2025:7927250. doi: 10.1155/ijod/7927250. eCollection 2025.
PubMed 40771657
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level
- ClinicalTrials.gov ID
- NCT06463535
- Acronym / sponsor ID
- BU7720
- Conditions
- Diabetes Mellitus, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Jun 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.
Patient grouping
- Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
- Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) different clinical parameters were recorded ; plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (CAL). 6.Omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.
Detailed description
A parallel design randomized clinical trial was performed involving thirty participants divided into two groups, 15 participants in each group selected from the outpatient clinic in Oral medicine and Periodontology department.
Diabetic control was assessed by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 m. HbA1c was assessed at baseline, 3m, and 6m.
Patient grouping
- Group 1 (Type 2 Diabetes Mellitus patients with CPD + SRP and Omega-3)
- Group 2 (Type 2 Diabetes Mellitus patients with CPD + SRP) Periodontal treatment protocol
Group 1 and 2 patients were treated by non-surgical approach in following steps:
- Each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices.
- Full mouth SRP using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions.
- Chlorehexidine CHX mouthwash was prescribed for patients to be used twice daily.
- For each patient, follow up visits every 2 weeks were done to ensure plaque control.
- Patients were re- examined after 2 weeks (baseline), 3 and 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Drug: Omega 3, Procedure: SRP aloneType 2 Diabetes Mellitus patients with CPD + SRP and Omega-3 |
| group II | Active comparator | Procedure: SRP aloneType 2 Diabetes Mellitus patients with CPD + SRP |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients had type 2 DM for more than 2 years (diagnosed according to the American Diabetes Association criteria), with no other systemic problem. •Subjects had 14 or more natural teeth, of which at least five had a site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment level ≥ 3 mm. From this point, according to the American Academy of Periodontology, subjects with moderate to severe periodontitis were included
Key exclusion criteria (1 listed)
- Pregnant and breastfeeding women, smokers or former smokers, patients with other autoimmune or systemic disease, those patients who took antibiotics in the last 6 months and patients weren't willing to follow our study protocol or plaque regimen
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 |
|---|---|---|
| Omega 3SRP + OMEGA 3 | Drug | group I |
| SRP aloneScaling and root planning | Procedure or surgery | group I, group II |
Primary outcome
Serum level of chemerin
Time frame: 6 months
Serum level of chemerin
4 secondary outcomes
periodontal clinical parameters
Time frame: 6 months
hba1c
Time frame: 6 months
GCF level of chemerin
Time frame: 6 months
periodontal clinical parameters
Time frame: 6 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 18 Jun 2024.
- Derived from this study: PubMed 40771657Ghalwash D, Ammar A, Hamdy A, El-Gawish A. Impact of the Adjunctive Use of Omega-3 in Periodontitis Patients With Diabetes on Local and Systemic Chemerin Levels: A Randomized Clinical Trial. Int J Dent. 2025 Jul 30;2025:7927250. doi: 10.1155/ijod/7927250. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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 study testing Omega 3 and SRP alone in people with Diabetes Mellitus and Periodontal Diseases, run by British University In Egypt at 1 site in Egypt.
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 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 18 Jun 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 Egypt. 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.
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?
Serum level of chemerin (time frame: 6 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 NCT06463535, which also lists 1 linked publication.
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 18 Jun 2024.