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Completed

NCT Number: NCT04769271

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and Root Planing

Procedure

Supra- and sub-gingival calculus and debris were removed

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis (A Clinical and Biochemical Study)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2021
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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