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

• ClinicalTrials.gov Identifier: NCT04769271
• Recruitment Status: Completed
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: Alexandria University
• Information provided by (Responsible Party): Maha Talaab, Alexandria University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Periodontitis	Procedure: Scaling and Root Planing; Drug: Scaling and Root Planing with tea tree oil	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis (A Clinical and Biochemical Study)
• Actual Study Start Date: November 10, 2019
• Actual Primary Completion Date: August 15, 2020
• Actual Study Completion Date: August 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Probing depth [ Time Frame: 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.
2. Clinical attachment loss [ Time Frame: 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.
3. Bleeding on probing [ Time Frame: 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.
4. Biochemical assessment of inlammation [ Time Frame: 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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Egypt

Faculty of Dentistry, Alexandria University

Alexandria, Egypt, 21527

Sponsors and Collaborators

Alexandria University

Investigators

• Study Chair: Maha R. Taalab, PhD; Faculty of Dentistry, Alexandria University, Egypt
• 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.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Maha Talaab, Associate Professor, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology department, Alexandria University
• ClinicalTrials.gov Identifier: NCT04769271
• Other Study ID Numbers: Tea tree oil & periodontitis
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tea Tree Oil; Anti-Infective Agents, Local; Anti-Infective Agents