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

NCT ID: NCT04769271

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2020-08-25

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scaling and Root Planing (SRP)

Group Type: ACTIVE_COMPARATOR

Scaling and Root Planing

Intervention Type: PROCEDURE

Supra- and sub-gingival calculus and debris were removed

Scaling and Root Planing with tea tree oil

Group Type: EXPERIMENTAL

Scaling and Root Planing with tea tree oil

Intervention Type: DRUG

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

Interventions

Scaling and Root Planing

Supra- and sub-gingival calculus and debris were removed

Intervention Type: PROCEDURE

Scaling and Root Planing with tea tree oil

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Maha Talaab

Associate Professor, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha R. Taalab, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Dania M. Abdel Aziz, BDS

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Sabah A Mahmoud, PhD

Role: STUDY_DIRECTOR

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

Riham M El Moslemany, PhD

Role: STUDY_DIRECTOR

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

Locations

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 33952216 (View on PubMed)

Other Identifiers

Tea tree oil & periodontitis

Identifier Type: -

Identifier Source: org_study_id