Effect of nutritional supplementation of Moringa oleifera on immune response in gum disease in humans

Not Applicable

Conditions: Health Condition 1: K053- Chronic periodontitis

Registration Number: CTRI/2022/02/040594

Lead Sponsor: MGM Institute of Health Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Systemically healthy participants above age of 18 years to 65 years rendering informed consent to participate in the study.

2.Participants with at least 20 permanent teeth present in the mouth with Generalized periodontitis as per American Academy of Periodontology / European Federation of Periodontology 2017 classification, defined as having 30 percent of the teeth examined with probing depth greater than 4mm, bleeding on probing, clinically evident attachment loss and radiographically evident bone loss.

Exclusion Criteria

1.Participants having taken anti-inflammatory drugs within the past 3 months

2.Participants having taken antimicrobial drugs within the past 3 months

3.Participants having taken nutritional supplements in the past 3 months

4.Participants taking immunosuppressant and immunomodulatory drugs

5.Participants with autoimmune disease

6.Participants with diabetes and hypertension

7.Participants consuming tobacco in any form and alcohol consumers

8.Participants with ongoing pregnancy and nursing mothers

9.Participants having undergone any periodontal treatment within the past 6 months

10.Participants having taken herbal home remedies during the past 3 months

11.Teeth with periodontal endodontic lesions

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in Probing depth [PD] <br/ ><br>2. Change in Relative clinical attachment level [RCAL] <br/ ><br>3. Change in Gingival recession [GR] <br/ ><br> <br/ ><br>Timepoint: 1. At Baseline <br/ ><br>2. At 6 weeks from Baseline <br/ ><br>3. At 12 weeks from Baseline

Secondary Outcome Measures

Name	Time	Method
Change in T cell associated cytokines: <br/ ><br>GM-CSF [ Ganulocyte-macrophage colony stimulating factor] <br/ ><br>IFN-Î± [ Interferon alpha] <br/ ><br>IFN-Î³ [ Interferon gamma] <br/ ><br>IL-2 [ Interleukin 2] <br/ ><br>IL-4 [ Interleukin 4] <br/ ><br>IL-5 [ Interleukin 5] <br/ ><br>IL-6 [ Interleukin 6] <br/ ><br>IL-9 [ Interleukin 9] <br/ ><br>IL-10 [ Interleukin 10] <br/ ><br>IL-12p70 [ Interleukin 12] <br/ ><br>IL-17A [ Interleukin 17 A] <br/ ><br>TNF-Î± [ Tumor necrosis factor alpha] <br/ ><br>Timepoint: Baseline <br/ ><br>6 weeks <br/ ><br>12 weeks