- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05803031
Efficacy of Locally Delivered Tea Tree Oil Gel as an Adjunct to Non-Surgical Periodontal Management
Efficacy of Locally Delivered Tea Tree Oil Gel as an Adjunct to Non-Surgical Periodontal Management (A Randomized Controlled Clinical Trial With Biochemical Analysis)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim & objectives of the Study:
The aim of this randomized controlled clinical and biochemical trial is to assess the efficacy of locally applied Melaleuca Alternifolia (tea tree oil) gel as a supplement to non-surgical periodontal debridement in the treatment of patients with localized periodontitis.
Primary objectives:
- Assess the effectiveness of tea tree oil gel in the management of periodontitis using clinical parameters.
- Evaluate Patients' satisfaction using the patient satisfaction questionnaire.
Secondary objective:
• Determine the impact of tea tree oil gel on the level of Tumor Necrosis Factor (TNF-α) in the gingival crevicular fluid.
Treatment protocol and intervention:
- Preoperative periapical radiographs will be done initially to determine the level of bone using a standard periapical parallel technique with digital sensor.
- The patients will undergo full mouth one stage debridement using ultrasonic scalers, manual scalers and curettes.
- Full mouth periodontal charting and samples from gingival crevicular fluid will be obtained using a sterile perio-paper inserted into the deepest periodontal pocket with horizontal bone loss immediately after finishing phase I therapy.
- Melaleuca Alternifolia Gel will be gently administered in the deepest pocket by syringe with blunt tip and the syringe will be removed slowly to avoid injuring the tissues for group I patients after phase 1 therapy by two weeks.
- After 3 months of phase I therapy, the patients will be followed up with evaluation of the clinical parameters.
Social & scientific values: Provide the dentists a more convenient way to reduce periodontal pockets in periodontitis patient by locally applying Melaleuca Alternifolia gel as an adjunct to non-surgical periodontal debridement.
Risks to study participants: The participants are not subjected to any risks.
Benefits to study participants:
Since the main objective of the research is using tea tree oil as a local delivery drug in the gel form to be placed in periodontal pockets as an adjunct to non-surgical periodontal debridement for the management of localized periodontitis, the benefit of the research is to provide the patient better therapeutic effect and a safe local delivery drug with no adverse reactions.
Benefits of the study to the community: Determination of the impact of tea tree oil gel on the level of Tumor necrosis factor-alpha (TNF-α) in the gingival crevicular fluid.
Privacy, Record keeping & confidentiality: All patients' data, information and study results will be kept under strict confidentiality and will be stored and kept as required. Only the primary researcher and the main investigator will have access to such data during the period of the study. At the end of the study all participants will be informed with the results and outcomes of the study as well as any health issues if found concerning them.
The study has been approved and accepted by the Diagnosis, Oral Medicine and Periodontology Department as approved by the endorsement released from the departments' committee with the code: OMD-2021-11 on Sunday 7/11/2020.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 11566
- Ain Shams University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I (Test group)
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.
|
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.
Scaling and root surface debridement
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Placebo Comparator: Group II (Control group)
Eleven patients with localized periodontitis, receiving full mouth non-surgical periodontal debridement only.
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Scaling and root surface debridement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing Depth
Time Frame: 3 months
|
Measured in mm from gingival margin to periodontal pocket using a periodontal probe.
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3 months
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Evaluate Patients' satisfaction
Time Frame: 3 months
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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.
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3 months
|
Clinical attachment level
Time Frame: 3 months
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Measured in mm from cemento-enamel junction to the depth of the periodontal pocket.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of Tumor Necrosis Factor (TNF-α) in the gingival crevicular fluid
Time Frame: 3 months
|
GCF will be collected with sterile periopaper strips.
The periopaper should be gently inserted into the gingival crevice until slight resistance is felt.
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1045
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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