A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus ("SLSRPD")
8. oktober 2014 oppdatert av: Manasa Ambati, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hyderabad, India, 500060
- Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år til 50 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Lycored soft gels , Scaling and Rootplaning.
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
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Lycopene 8mgms taken orally ,one per day for two months.
Andre navn:
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
Andre navn:
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Eksperimentell: Scaling and Rootplaning only.
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.
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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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Serum MDA
Tidsramme: 6 Months Post treatment.
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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.
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6 Months Post treatment.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Modified Gingival Index
Tidsramme: 6 Months post treatment.
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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.
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6 Months post treatment.
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Change in Probing pocket depth (PPD)
Tidsramme: 6 Months post treatment.
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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.
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6 Months post treatment.
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Change in Clinical attachment level (CAL)
Tidsramme: 6 Months post treatment.
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The change in CAL from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
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6 Months post treatment.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dr.Manasa Ambati, MDS(Perio), Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- Chandra 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.
- Cohen 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2013
Primær fullføring (Faktiske)
1. mars 2013
Studiet fullført (Faktiske)
1. august 2013
Datoer for studieregistrering
Først innsendt
1. oktober 2014
Først innsendt som oppfylte QC-kriteriene
8. oktober 2014
Først lagt ut (Anslag)
13. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. oktober 2014
Sist bekreftet
1. oktober 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10/98/12
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