Chronic Periodontitis
Conditions
Keywords
chronic periodontitis, Emblica officinalis (amla), antioxidant
Brief summary
This study aimed to evaluate the influence of amla (Emblica officinalis) on patients with chronic generalized periodontitis, using a single-blind, randomized controlled study design. 1. At baseline, all participants fulfilling the I/E criteria would be randomized into Arm I or II. 2. All participants in Arm I and II would undergo scaling and root planing (SRP). 3. After 1 month, Arm I participants would receive adjunct amla for 2 weeks, and Arm II participants would receive no treatment. 4. Both arms would be followed until the end of 6 months and evaluated for clinical and biochemical parameters.
Detailed description
The study is a randomized, single-blind, controlled trial, involving thirty chronic generalized periodontitis patients aged between 25 to 60 years. Participants fulfilling the Inclusion/ Exclusion criteria participants would be randomized to Arm I or II. They would be subjected to scaling and root planing (SRP). After 1 month, Arm I participants would be given amla for 2 weeks, while no adjunct therapy is planned for the participants in Arm II. Clinical parameters such as plaque index, gingival index, bleeding index, probing pocket depth, and clinical attachment loss would be assessed at baseline, 1, 3 and 6 months post-treatment. Biochemical parameters malondialdehyde (MDA) and glutathione (GTH) would be measured by spectrophotometry, while ELISA would be performed to assess the tumor necrosis factor-α (TNF- α), and C-reactive protein (CRP) in serum and saliva, at baseline and 6 months. Statistical analysis is proposed using SPSS or STATA 14 package.
Interventions
DIETARY_SUPPLEMENTScaling and root planing + Amla
Chronic generalized patients were randomly assigned to Arm I and Arm II. Arm I participants underwent scaling and root planing followed by consumption of a whole amla berry.
OTHERScaling and root planing
Chronic generalized patients were randomly assigned to Arm I and Arm II. Arm II participants underwent scaling and root planing only.
Sponsors
Mahatma Gandhi Postgraduate Institute of Dental Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigator and outcome assessor were not aware of the arms or the intervention received. The additional intervention (amla dispensing) was conducted by another member, not involved in the study.
Intervention model description
The study is a single-blind, randomized controlled trial, where one arm receives scaling and root planing along with amla (after 1 month of SRP). The other arm receives only scaling and root planing.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have at least 20 remaining teeth, with chronic generalized periodontitis, as defined as \> 30 % sites involved (extent) and with moderate to severe involvement (severity) as characterized by \> 2 interproximal sites with clinical attachment loss (CAL) \> 4mm (not on the same tooth) AND/OR \> 5 mm, probing depth (not on the same tooth) AND/OR \> 2 interproximal sites with CAL \> 6 mm AND 1 interproximal site with PD \> 5mm. 2. Systemically healthy patients
Exclusion criteria
1. Medically compromised patients 2. Smokers 3. Pregnant and lactating women 4. Patients on cholesterol-lowering medication 5. Patients who had received any antimicrobial therapy in the past 2 months, on ongoing antimicrobial therapy, or would receive antimicrobials during the course of the study. 6. Patients who had undergone any periodontal surgery in the past 6 months 7. Patients with a high caries index 8. Patients with severe tooth hypersensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in clinical parameters (plaque index) | 1, 3 and 6 months | Improvement in plaque index |
| Improvement in clinical parameters (gingival index) | 1,3 and 6 months | Improvement in gingival index |
| Improvement in clinical parameters (bleeding index) | 1,3 and 6 months | Improvement in bleeding index |
| Improvement in clinical parameters (probing pocket depth) | 1,3 and 6 months | Improvement in probing pocket depth |
| Improvement in clinical parameters (clinical attachment level) | 1,3 and 6 months | Improvement in clinical attachment level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in antioxidant levels (Malondialdehyde) in saliva and serum | 6 months | Changes in levels of Malondialdehyde |
| Changes in antioxidant levels (glutathione) in saliva and serum | 6 months | Changes in glutathione levels |
| Changes in anti-inflammatory marker levels (CRP) in serum and saliva | 6 months | Changes in C reactive protein levels |
| Changes in anti-inflammatory marker levels (TNF-alpha) in serum and saliva | 6 months | Changes in TNF-alpha levels |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORGrace T Paul, MDS
Mahatma Gandhi Postgraduate Institute of Dental Sciences
Outcome results
None listed