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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769271
• Other study ID #: Tea tree oil & periodontitis
• Status: Completed
• Phase: Phase 2
• Start date: November 10, 2019
• Est. completion date: August 25, 2020

Study information

• Verified date: February 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 25, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Scaling and Root Planing
Supra- and sub-gingival calculus and debris were removed

Drug:
• Scaling and Root Planing with tea tree oil
Supra- and sub-gingival calculus and debris were removed and 5% tea tree oil was applied

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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