Efficacy of Locally Delivered Tea Tree Oil Gel as an Adjunct to Non-Surgical Periodontal Management

Summary

Periodontitis is an inflammatory disease of the teeth's supporting tissues caused by specific microbes or groups of microorganisms that contributes to gradual deterioration of the periodontal ligament and alveolar bone, leading to periodontal pockets, gingival recession, or both. Periodontitis is generally known to be caused by the continuous destruction of the surrounding periodontium by complexly organized bacterial communities that colonizes the tooth surface, gingival margin, and subgingival area in the form of dental plaque biofilm. Researchers suggest the dependence of the treatment of periodontal disease on controlling the residual mass of periodontal microbes. Therefore, it is proposed that non-surgical therapy is regarded as the initial treatment of periodontitis, which includes mechanical therapy, such as oral hygiene measures and mechanical debridement like scaling and root planning. Chemical therapy could supplement the non-surgical mechanical therapy, including antimicrobials that can be systemically or locally delivered. Systemic delivery of antimicrobials plays a critical role in reaching microorganisms dispersed in the oral cavity, including those in non-dental oral niches, such as the dorsum of the tongue and crypts of tonsils. Despite these advantages, it might lead to unwanted systemic effects -such as nausea, vomiting, and gastrointestinal discomfort- or bacterial resistance, as it is completely dependent on the patient's adherence. Local Drug Delivery (LDD), compared to systemic administration, provides higher therapeutic concentrations of antibiotics at site of infection that is inaccessible to the systemic route and it is independent of patient's adherence, as has been shown in various studies. Natural products have long been an important source of medications, with natural ingredients accounting for almost half of all pharmaceuticals currently in use. Oriental medicines have been studied for their antibacterial and anti-inflammatory properties, as well as periodontal tissue regeneration, in the treatment of periodontal disease. Tea tree oil (TTO), which is an example of one of these natural products, is obtained from paper bark tea tree. Tea tree oil was made from natural bush stands of plants, allegedly Melaleuca alternifolia, that generated oil with the required chemotype during that early stage. Melaleuca alternifolia's native habitat is low-lying, swampy, subtropical coastal ground along the Clarence and Richmond Rivers in northeastern New South Wales and southern Queensland, and it does not occur natively beyond Australia, unlike numerous other Melaleuca species. Tea tree oil, commonly known as "oil of the Tea tree" or "Melaleuca essential oil," is one of the most well-known essential oils. It's made from the Melaleuca alternifolia tree's leaves, which have been distilled. This plant is a member of the Myrtaceae family, which includes Australian arboreal plants. It is known as "nature's most versatile healer" among the native populations. Tea tree oil (TTO) possesses antibacterial, anti-inflammatory, antifungal, antiviral, antioxidant, and antiprotozoal properties. Components of tea tree oil include: Terpinen-4-ol, α-Terpinene, γ -Terpinene, 1,8-Cineole, α -Terpinolene, p-Cymene, (+)-α-Pinene, α -Terpineol, Aromadendrene, δ -Cadinene, (+)-Limonene, Sabinene, and Globulol. The capacity of TTO components to reduce the production of TNF α, IL-1beta, IL-8, IL-10, and PGE2 by lipopolysaccharide activated human monocytes shows TTO's anti-inflammatory action, according to the researchers. TTO's major active components are 1,8-cineole and Terpinen-4-ol, and it has been shown that 1,8-cineole possesses anti-inflammatory characteristics and may permeate human skin. Other research suggests that Terpinen-4-ol not only has anti-inflammatory characteristics like 1,8-cineol, but also has anti-bacterial capabilities. TTO has the same antibacterial effect as chlorhexidine (CHX), however the mode of action is different. Antibacterial, antiviral, and antifungal activities are all present. According to researches, TTO is capable of lowering both inflammatory mediators and periodontal pathogens, which in turn reduces the stimulation of inflammatory cytokines, allowing periodontal tissues to repair when applied locally in periodontal pockets. Melaleuca Alternifolia was chosen for this study as a local drug delivery in the gel form to be placed in periodontal pockets as an adjunct to non-surgical periodontal debridement for the management of localized periodontitis due to its therapeutic effects, ease of availability of tea tree oil, cost effectiveness, and safety with no adverse reactions.

Conditions

• Periodontal Pocket

Interventions

DRUG

Melaleuca Alternifolia Oil

Tea tree oil 5% gel (Sigma Aldrich® Steinheim, Germany) for local sub gingival application was prepared by the Department of Pharmaceutics, Faculty of Pharmacy. The gelling agent; Carbopol 940 (1% w/v) was first soaked in distilled water for 2 h then TTO dissolved in an appropriate amount of propylene glycol was added to the Carbopol dispersion. Methyl paraben 0.2% w/v dissolved in preheated water was used as a preservative. The gel mixture was then magnetically stirred for 30 min. Finally, pH was adjusted using 1 N NaOH added dropwise with gentle stirring with a spatula until the desired pH value (6.5-7) was reached. The gel was sterilized by autoclaving at 110 °C for 20 min.

PROCEDURE

Non-surgical periodontal debridement

Scaling and root surface debridement

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-01

Primary Completion

2023-02-01

Completion

2023-02-23

Countries

• Egypt

Study Locations