Periodontal Diseases
Conditions
Keywords
periodontitis, P. gingivalis, P. intermedia, local drug delivery
Brief summary
The goal of this clinical trial is to learn if the herbal gel is more effective as compared to placebo in reducing periodontal inflammation in patients with periodontal disease. The clinicians shall check various periodontal parameters in the subjects over a scheduled duration. Participants will be administered the gel once subgingivally and the periodontal parameters shall be recorded before gel delivery then again after 1,3 and 6 months. Plaque samples were taken at baseline and 6 months
Detailed description
Chronic periodontitis is a prevalent inflammatory condition primarily caused by bacterial plaque biofilm, leading to progressive attachment and bone loss. Scaling and root planing (SRP) is the gold standard for its management. Recently, natural and herbal-based adjuncts have gained attention for their antimicrobial and anti-inflammatory properties. This study aimed to evaluate the clinical and microbiological effectiveness of 4% avocado gel as an adjunct to SRP in the treatment of chronic periodontitis. A randomized controlled clinical trial was conducted on patients diagnosed with chronic periodontitis. Subjects were divided into two groups: Group I received SRP with subgingival application of placebo gel, and Group II received SRP along with subgingival application of 4% avocado gel. Clinical parameters, including Plaque Index (PI), Papilla Bleeding Index (PBI), Probing Pocket Depth (PPD), and Relative Attachment Level (RAL), were recorded at baseline and after 4th week and 12th week. Microbiological analysis was conducted at recorded at baseline, 4th week,12th week and 24th week to assess the presence of Porphyromonas gingivalis and Prevotella intermedia using culture methods.
Interventions
DRUGplacebo gel
local drug delivery of placebo gel
DRUGherbal drug
local drug delivery of herbal gel
Sponsors
Rungta College of Dental Sciences and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with Chronic periodontitis having periodontal pockets (non-adjacent sites) of \>5mm
Exclusion criteria
* history of any systemic disease, Antibiotic treatment during the 6 months period prior to the study, Pregnant and lactating woman, Periodontal treatment during the previous 3 months, Severe caries or extensive restoration on the objective teeth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Papilla Bleeding Index | 3 months |
| Plaque Index | 3 months |
| Probing Pocket Depth | 3 months |
| Relative Attachment Level | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CFUs | 6 months | Colony Forming Units |
Countries
India
Outcome results
None listed