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

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Scaling and Root Planing; Drug: Scaling and Root Planing with tea tree oil

• Registration Number: NCT04769271
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2019-11-10
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-25
• Status Verified: 2021-02
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-21
• Last Update Submitted: 2021-02-21
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and Root Planing (SRP)	Scaling and Root Planing	-
Scaling and Root Planing with tea tree oil	Scaling and Root Planing with tea tree oil	-

Primary Outcome Measures

Name	Time	Method
Probing depth	up to 6 months	Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.
Clinical attachment loss	up to 6 months	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.
Biochemical assessment of inlammation	up to 6 months	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.
Bleeding on probing	up to 6 months	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt