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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Scaling and Root Planing; Drug: Scaling and Root Planing with tea tree oil

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Scaling and Root Planing (SRP)	Procedure: Scaling and Root Planing; Supra- and sub-gingival calculus and debris were removed
Experimental: Scaling and Root Planing with tea tree oil	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

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Dania M. Abdel Aziz, BDS, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Sabah A Mahmoud, PhD, Medical Biochemistry and Molecular Biology department. Faculty of Dentistry, Alexandria University, Alexandria, Egypt.; Study Director: Riham M El Moslemany, PhD, Pharmaceutics department. Faculty of Pharmacy, Alexandria University; Alexandria, Egypt.

Publications and helpful links

General Publications

• Taalab MR, Mahmoud SA, Moslemany RME, Abdelaziz DM. Intrapocket application of tea tree oil gel in the treatment of stage 2 periodontitis. BMC Oral Health. 2021 May 5;21(1):239. doi: 10.1186/s12903-021-01588-y.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Tea Tree Oil
• Other Study ID Numbers: Tea tree oil & periodontitis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No