Positive Regulation of Oxidative Stress ProcessPhase 4"SLSRPD"NCT02263352
A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus
A Phase 4 study testing Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day and Scaling and root planing in people with Positive Regulation of Oxidative Stress Process, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Positive Regulation of Oxidative Stress Process
- What is being tested?
- Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day and Scaling and root planing
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2013to Aug 2013
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes
- Patients on oral hypoglycemic drugs with no modification in therapy from the past 12 months
- Chronic periodontitis as per AAP (American Academy of Periodontology) guidelines
- Minimum of 15 natural teeth
- At least four teeth with one or more sites with probing depth (PD) greater than or equal to 5 mm, clinical attachment level (CAL) greater than or equal to 4mm and bleeding on probing (BOP).
Who cannot join
- History of antibiotic therapy within the previous 6 months
- History of anti-inflammatory drugs within the previous 3 months
- Pregnancy and lactation
- Use of contraceptives or any other form of hormone
- Usage of tobacco and tobacco related products
- Periodontal treatment within 12 months.
Trial locations and contacts
1 site in 1 country.
India1 site
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Hyderabad, 500060
About this study
Official title: Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus
This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus.
Read the detailed description
This study is a randomized double blinded clinical trial which was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes were measured at baseline, 2 months and 6 months.
The results were that the Lycopene with scaling and root planing group gave:
Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months respectively.
- Being tested
- Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day, Scaling and root planing
- Keywords
- Diabetes, Periodontitis, Oxidative stress, Antioxidant
- 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.
Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/dayDrug
Also called rhodopurpurin,non-provitamin A carotenoid,
Lycopene 8mgms taken orally ,one per day for two months.
Scaling and root planingDevice
Also called Nonsurgical periodontal therapy, Conventional periodontal therapy.
Scaling and root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus
| Study group | Role | What they receive |
|---|---|---|
| Lycored soft gels , Scaling and Rootplaning. | Experimental | Systemic Lycored soft gels,(Jagsonpal Pharma) was given orally 8mgms/day for 2 months and Scaling and rootplaning (otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline Receives: Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day; Device: Scaling and root planing |
| Scaling and Rootplaning only. | Experimental | Scaling and rootplaning(otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline. Receives: Device: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum MDA
This unique outcome measure was assessed from baseline to 6 months post treatment by spectrophotometric estimation of serum Thiobarbituric acid substances (TBARS). The TBARS Assay measures malondialdehyde (MDA), a reactive compound formed from lipid peroxides that are generated under conditions of oxidative stress. Oxidative modification of lipids occurs with aging and various diseases, and increased oxidative stress is associated with diabetes and its complications. MDA forms an adduct with thiobarbituric acid (TBA). Results are calculated from a standard curve constructed with authentic MDA.
Measured: 6 Months Post treatment.
Secondary outcomes (3)
Change in Modified Gingival Index
The change in Modified gingival index from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
Measured: 6 Months post treatment.
Change in Probing pocket depth (PPD)
The change in Probing pocket depth from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
Measured: 6 Months post treatment.
Change in Clinical attachment level (CAL)
The change in CAL from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
Measured: 6 Months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Positive Regulation of Oxidative Stress ProcessStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health and Nutrition
- Responsible party
- Principal investigator, Manasa Ambati, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Dr.Manasa Ambati, MDS(Perio), Principal investigator, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263352
- Sponsor's protocol ID
- 10/98/12
- Acronym
- "SLSRPD"
- Status last verified
- Oct 2014
- First submitted
- 1 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Neyestani TR, Shariatzadeh N, Gharavi A, Kalayi A, Khalaji N. Physiological dose of lycopene suppressed oxidative stress and enhanced serum levels of immunoglobulin M in patients with Type 2 diabetes mellitus: a possible role in the prevention of long-term complications. J Endocrinol Invest. 2007 Nov;30(10):833-8. doi: 10.1007/BF03349224.
PubMed 18075285Chandra RV, Prabhuji ML, Roopa DA, Ravirajan S, Kishore HC. Efficacy of lycopene in the treatment of gingivitis: a randomised, placebo-controlled clinical trial. Oral Health Prev Dent. 2007;5(4):327-36.
PubMed 18173095Cohen DW, Friedman LA, Shapiro J, Kyle GC, Franklin S. Diabetes mellitus and periodontal disease: two-year longitudinal observations. I. J Periodontol. 1970 Dec;41(12):709-12. doi: 10.1902/jop.1970.41.12.709. No abstract available.
PubMed 5275715
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02263352
- Acronym / sponsor ID
- "SLSRPD" / 10/98/12
- Keywords
- Diabetes, Periodontitis, Oxidative stress, Antioxidant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Collaborators
- National Institute of Health and Nutrition
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Oct 2014 (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.
This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus.
Detailed description
This study is a randomized double blinded clinical trial which was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes were measured at baseline, 2 months and 6 months.
The results were that the Lycopene with scaling and root planing group gave:
Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lycored soft gels , Scaling and Rootplaning. | Experimental | Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day, Device: Scaling and root planingSystemic Lycored soft gels,(Jagsonpal Pharma) was given orally 8mgms/day for 2 months and Scaling and rootplaning (otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline |
| Scaling and Rootplaning only. | Experimental | Device: Scaling and root planingScaling and rootplaning(otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus) which was performed at baseline. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- Patients on oral hypoglycemic drugs with no modification in therapy from the past 12 months
- Chronic periodontitis as per AAP (American Academy of Periodontology) guidelines
- Minimum of 15 natural teeth
- At least four teeth with one or more sites with probing depth (PD) greater than or equal to 5 mm, clinical attachment level (CAL) greater than or equal to 4mm and bleeding on probing (BOP).
Key exclusion criteria (6 listed)
- History of antibiotic therapy within the previous 6 months
- History of anti-inflammatory drugs within the previous 3 months
- Pregnancy and lactation
- Use of contraceptives or any other form of hormone
- Usage of tobacco and tobacco related products
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 |
|---|---|---|
| Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/dayAlso: rhodopurpurin,non-provitamin A carotenoid,Lycopene 8mgms taken orally ,one per day for two months. | Drug | Lycored soft gels , Scaling and Rootplaning. |
| Scaling and root planingAlso: Nonsurgical periodontal therapy, Conventional periodontal therapy.Scaling and root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus | Device | Lycored soft gels , Scaling and Rootplaning., Scaling and Rootplaning only. |
Primary outcome
Change in Serum MDA
Time frame: 6 Months Post treatment.
This unique outcome measure was assessed from baseline to 6 months post treatment by spectrophotometric estimation of serum Thiobarbituric acid substances (TBARS). The TBARS Assay measures malondialdehyde (MDA), a reactive compound formed from lipid peroxides that are generated under conditions of oxidative stress. Oxidative modification of lipids occurs with aging and various diseases, and increased oxidative stress is associated with diabetes and its complications. MDA forms an adduct with thiobarbituric acid (TBA). Results are calculated from a standard curve constructed with authentic MDA.
3 secondary outcomes
Change in Modified Gingival Index
Time frame: 6 Months post treatment.
Change in Probing pocket depth (PPD)
Time frame: 6 Months post treatment.
Change in Clinical attachment level (CAL)
Time frame: 6 Months post treatment.
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 Oct 2014.
- Background: PubMed 18075285Neyestani TR, Shariatzadeh N, Gharavi A, Kalayi A, Khalaji N. Physiological dose of lycopene suppressed oxidative stress and enhanced serum levels of immunoglobulin M in patients with Type 2 diabetes mellitus: a possible role in the prevention of long-term complications. J Endocrinol Invest. 2007 Nov;30(10):833-8. doi: 10.1007/BF03349224.
- Background: PubMed 18173095Chandra RV, Prabhuji ML, Roopa DA, Ravirajan S, Kishore HC. Efficacy of lycopene in the treatment of gingivitis: a randomised, placebo-controlled clinical trial. Oral Health Prev Dent. 2007;5(4):327-36.
- Results publication: PubMed 5275715Cohen DW, Friedman LA, Shapiro J, Kyle GC, Franklin S. Diabetes mellitus and periodontal disease: two-year longitudinal observations. I. J Periodontol. 1970 Dec;41(12):709-12. doi: 10.1902/jop.1970.41.12.709. No abstract available.
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.
Dr.Manasa Ambati, MDS(Perio) principal investigator
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day and Scaling and root planing in people with Positive Regulation of Oxidative Stress Process, 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?
The sponsor lists 5 inclusion and 6 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 Oct 2014. 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. 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?
Change in Serum MDA (time frame: 6 Months Post treatment.). 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 NCT02263352, which also lists 3 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 Oct 2014.