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

NCT05803031 | Completed DMC

• 1 other identifier: 1045
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Local Drug Delivery; Periodontitis; Tea Tree Oil

Outcome Measures

Primary Outcomes (3)

• Probing Depth

  Measured in mm from gingival margin to periodontal pocket using a periodontal probe.

  3 months

• Evaluate Patients' satisfaction

  The response choices requested the patients to assign a 5-point rating scale to each item. Responses would be rated from 1 to 5, with 1 being a total disagree and 5 representing a total agreement. Higher scores therefore represent better patient satisfaction.

  3 months

• Clinical attachment level

  Measured in mm from cemento-enamel junction to the depth of the periodontal pocket.

  3 months

Secondary Outcomes (1)

• Level of Tumor Necrosis Factor (TNF-α) in the gingival crevicular fluid

  3 months

Study Arms (2)

Group I (Test group)

EXPERIMENTAL

Eleven patients with localized periodontitis, receiving full mouth non-surgical periodontal debridement followed by local delivery of tea tree oil gel as an adjunctive treatment.

Drug: Melaleuca Alternifolia Oil; Procedure: Non-surgical periodontal debridement

Group II (Control group)

PLACEBO COMPARATOR

Eleven patients with localized periodontitis, receiving full mouth non-surgical periodontal debridement only.

Procedure: Non-surgical periodontal debridement

Interventions

Melaleuca Alternifolia Oil DRUG

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.

Group I (Test group)

Non-surgical periodontal debridement PROCEDURE

Scaling and root surface debridement

Group I (Test group); Group II (Control group)

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females with age range of 25-50years.
• Patients diagnosed to have (Stage II or Stage III) periodontitis; (3-6 mm CAL, pocket depth ≤ 7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis).
• Systemic (medically) free patients.
• Patients who can follow and maintain oral hygiene instructions.

You may not qualify if:

• Pregnant ladies or lactating mothers.
• Smokers.
• Patients with history of allergy against one of the components of tea tree oil.
• Asthmatic patients.
• Periodontal therapy in the last 6 months

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis

Interventions

Tea Tree Oil

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oils, Volatile; Oils; Lipids; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the type of the intervention and the whole-time frame of the study will be 12 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was designed to be a Randomized, Controlled, Parallel design, Two arms clinical trial. The patients will be randomly allocated to one of the two groups; test and control group using computer generated random tables (www.randomizer.org ) .

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: April 7, 2023
• Study Start: November 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 23, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

EG (1)