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

NCT04769271 | Completed Phase 2

• 1 other identifier: Tea tree oil & periodontitis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Scaling and Root Planing (SRP)

ACTIVE COMPARATOR

Procedure: Scaling and Root Planing

Scaling and Root Planing with tea tree oil

EXPERIMENTAL

Drug: Scaling and Root Planing with tea tree oil

Interventions

Scaling and Root Planing PROCEDURE

Supra- and sub-gingival calculus and debris were removed

Scaling and Root Planing (SRP)

Scaling and Root Planing with tea tree oil DRUG

Supra- and sub-gingival calculus and debris were removed and 5% tea tree oil was applied

Scaling and Root Planing with tea tree oil

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33952216 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Tea Tree Oil

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Oils, Volatile; Oils; Lipids; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Maha R. Taalab, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Dania M. Abdel Aziz, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology department

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: November 10, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 25, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

EG (1)