Diabetes MellitusEARGDNCT02775266
Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes
A study testing Alpha lipoic acid and Scaling and Root planing in people with Diabetes Mellitus and Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Periodontitis
- What is being tested?
- Alpha lipoic acid and Scaling and Root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2016to Oct 2016
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: Diabetic patients with Chronic periodontitis.
-
Exclusion Criteria: Smokers, Pregnant \& lactating women, Prior periodontal therapy within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Systemic Administration of ALA (Alpha Lipoic Acid) as an Adjunct to Scaling and Rootplaning on Serum Resistin Levels in Patients With Chronic Periodontitis and Type 2 Diabetes Mellitus
To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease
Read the detailed description
A total of 40 patients with diabetes and chronic periodontitis attending the department of periodontics will be recruited in the study. 40 subjects will be randomly divided into two groups(control group and test group with 20 subjects in each group). Clinical parameters such as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood sample will be collected by venepuncture ( baseline and after 3 months) and stored in Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at baseline.
- Conditions
- Diabetes Mellitus, Periodontitis
- Being tested
- Alpha lipoic acid, Scaling and Root planing
- Medical subject headings
- Diabetes Mellitus, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acidOther
Scaling and root planing will be done at baseline and systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months.
Scaling and Root planingProcedure or surgery
Scaling and root planing will be done at baseline.
| Study group | Role | What they receive |
|---|---|---|
| ALA + Scaling and Root planing | Active comparator | Systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B) Receives: Other: Alpha lipoic acid; Procedure: Scaling and Root planing |
| Scaling and root planing only | Placebo comparator | Patients will receive scaling and root planning at baseline and 3 months(group A) Receives: Procedure: Scaling and Root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Resistin Levels and HBAIC Levels
2ml of blood sample will be collected by venepuncture at baseline and after 3 months and will be assessed by ELISA stored in EDTA containing vials to identify the levels of resistin in the patients by ELISA.
Glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and assessed by Spectrophotometer.
Measured: 3 months
Secondary outcomes (3)
Gingival Index
Gingival index was recorded with william's periodontal probe at baseline and after 3 months
Measured: 3 months
Probing pocket depth
Were recorded with william's periodontal probe at baseline and after 3 months
Measured: 3 months
Clinical Attachment levels
Were recorded with william's periodontal probe at baseline and after 3 months
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 posted17 May 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kinnera surapaneni, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Kinnera Surapaneni, [MDS], Principal investigator, PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD - 500060Rekha R Koduganti, MDS Perio, Study director, Professor&HOD Dept.of.Periodontics,PMVIDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775266
- Sponsor's protocol ID
- 00159
- Acronym
- EARGD
- Status last verified
- Mar 2017
- First submitted
- 5 May 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.
PubMed 16881798Pendyala G, Thomas B, Kumari S. The challenge of antioxidants to free radicals in periodontitis. J Indian Soc Periodontol. 2008 Sep;12(3):79-83. doi: 10.4103/0972-124X.44100.
PubMed 20142950
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Administration of ALA (Alpha Lipoic Acid) as an Adjunct to Scaling and Rootplaning on Serum Resistin Levels in Patients With Chronic Periodontitis and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02775266
- Acronym / sponsor ID
- EARGD / 00159
- Conditions
- Diabetes Mellitus, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 May 2016 (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.
To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease
Detailed description
A total of 40 patients with diabetes and chronic periodontitis attending the department of periodontics will be recruited in the study. 40 subjects will be randomly divided into two groups(control group and test group with 20 subjects in each group). Clinical parameters such as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood sample will be collected by venepuncture ( baseline and after 3 months) and stored in Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at baseline.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA + Scaling and Root planing | Active comparator | Other: Alpha lipoic acid, Procedure: Scaling and Root planingSystemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B) |
| Scaling and root planing only | Placebo comparator | Procedure: Scaling and Root planingPatients will receive scaling and root planning at baseline and 3 months(group A) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Alpha lipoic acidScaling and root planing will be done at baseline and systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months. | Other | ALA + Scaling and Root planing |
| Scaling and Root planingScaling and root planing will be done at baseline. | Procedure or surgery | ALA + Scaling and Root planing, Scaling and root planing only |
Primary outcome
Serum Resistin Levels and HBAIC Levels
Time frame: 3 months
2ml of blood sample will be collected by venepuncture at baseline and after 3 months and will be assessed by ELISA stored in EDTA containing vials to identify the levels of resistin in the patients by ELISA. Glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and assessed by Spectrophotometer.
3 secondary outcomes
Gingival Index
Time frame: 3 months
Probing pocket depth
Time frame: 3 months
Clinical Attachment levels
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 13 Mar 2017.
- Background: PubMed 16881798Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.
- Background: PubMed 20142950Pendyala G, Thomas B, Kumari S. The challenge of antioxidants to free radicals in periodontitis. J Indian Soc Periodontol. 2008 Sep;12(3):79-83. doi: 10.4103/0972-124X.44100.
- 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.
Kinnera Surapaneni, [MDS] principal investigator
PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD - 500060
Rekha R Koduganti, MDS Perio study director
Professor&HOD Dept.of.Periodontics,PMVIDS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha lipoic acid and Scaling and Root planing in people with Diabetes Mellitus and Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Mar 2017. 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 India. 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.
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 Resistin Levels and HBAIC Levels (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 NCT02775266, which also lists 2 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 13 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.