Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis

Study Overview
=================
Brief Summary
-----------------
This study aimed to assess clinically and biochemically the effect of intrapocket application of tea tree oil (TTO) gel adjunctive to SRP in the management of stage 2(moderate) periodontitis and to correlate the biochemical levels with clinical response.

Detailed Description
-----------------
A randomized, controlled clinical trial included thirty patients with stage 2 periodontitis. They were equally divided into two groups: Group 1 (control group) treated with scaling and root planning (SRP) alone and Group 2 (test group) managed by SRP and locally delivered 5% tea tree oil (TTO) gel.

Official Title
-----------------
Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis (A Clinical and Biochemical Study)

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Procedure: Scaling and Root Planing
* Drug: Scaling and Root Planing with tea tree oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with stage 2,grade B periodontitis according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Patients with CAL 3-4 mm , BOP and radiographic horizontal bone loss related to the coronal third of the root (15%-33%). Patients with no teeth loss due to periodontitis. Patients with radiographic bone loss/age % of 0.25-1 %. Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study. Exclusion Criteria: Patients with CAL caused by non periodontal causes. Patients with grade C periodontitis. Patients having any systemic disease that may affect the treatment outcomes Smokers. Pregnant females. Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scaling and Root Planing (SRP)<br> | Procedure: Scaling and Root Planing<br>* Supra- and sub-gingival calculus and debris were removed<br>|
| Experimental: Scaling and Root Planing with tea tree oil<br> | Drug: Scaling and Root Planing with tea tree oil<br>* Supra- and sub-gingival calculus and debris were removed and 5% tea tree oil was applied<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm. | up to 6 months | 
| Clinical attachment loss | Clinical attachment loss was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm. | up to 6 months | 
| Bleeding on probing | Bleeding on probing was assessed at tested sites with graduated William's probe graduated in 1 mm increment, within 15 seconds after probing, using a dichotomous scoring system (+ and -) for presence or absence, respectively. | up to 6 months | 
| Biochemical assessment of inlammation | This involved determination of the gingival crevicular fluid (GCF) levels of matrix metalloproteinase 8 (MPP-8). A GCF sample was taken from the area showing the deepest pocket depth around the treated area.The samples were diluted in phosphate buffer saline (PBS) up to 1 mL. After waiting for 15 min, the paper points were removed, and 500 μL were centrifuged at 400 g for 4 min, then frozen at -20°C pending MMP-8 analysis using Human Matrix metalloproteinase 8/Neutrophil collagenase (MMP-8) ELISA Kit according to the manufacturer instructions. | up to 6 months |