Back to results

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

Primary Purpose

Periodontitis

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Scaling and Root Planing

Scaling and Root Planing with tea tree oil

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scaling and Root Planing (SRP)

Scaling and Root Planing with tea tree oil

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04769271

First Posted

February 21, 2021

Last Updated

February 21, 2021

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04769271

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

November 10, 2019 (Actual)

Primary Completion Date

August 15, 2020 (Actual)

Study Completion Date

August 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scaling and Root Planing (SRP)

Arm Type

Active Comparator

Arm Title

Scaling and Root Planing with tea tree oil

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Scaling and Root Planing

Intervention Description

Supra- and sub-gingival calculus and debris were removed

Intervention Type

Drug

Intervention Name(s)

Scaling and Root Planing with tea tree oil

Intervention Description

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

Primary Outcome Measure Information:

Title

Probing depth

Description

Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.

Time Frame

up to 6 months

Title

Clinical attachment loss

Description

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.

Time Frame

up to 6 months

Title

Bleeding on probing

Description

Time Frame

up to 6 months

Title

Biochemical assessment of inlammation

Description

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maha R. Taalab, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dania M. Abdel Aziz, BDS

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sabah A Mahmoud, PhD

Organizational Affiliation

Medical Biochemistry and Molecular Biology department. Faculty of Dentistry, Alexandria University, Alexandria, Egypt.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Riham M El Moslemany, PhD

Organizational Affiliation

Pharmaceutics department. Faculty of Pharmacy, Alexandria University; Alexandria, Egypt.

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21527

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

33952216

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs